Beyfortus (nirsevimab) Effectiveness Against RSV Medically-Attended Events in Infants (BEAR Study)
This study will estimate the effectiveness of Beyfortus (nirsevimab) against PCR-confirmed RSV with a lower respiratory tract disease diagnosis & to estimate the effectiveness of nirsevimab against medical encounters for PCR-confirmed RSV with lower respiratory tract disease.
Investigator: Klein, Nicola
Funder: Sanofi
A Phase II, single-blind, randomized, controlled study to evaluate the immunogenicity and safety of a measles, mumps, rubella, varicella vaccine compared with ProQuad, administered in healthy children 4 to 6 years of age
This study will evaluate the immune response to the MMRVNS vaccines (formulated with different potencies) and the MMRV vaccine (pooled group) in terms of GMCs for antibodies to measles, mumps, rubella, and varicella viruses.
Investigator: Klein, Nicola
Funder: IQVIA RDS Inc.
CISA Clinical Evaluation (Contributing) CISA Clinical Vaccine Safety Evaluation – Contributing
We will provide clinical consultations to the CDC for vaccine safety cases, perform clinical case reviews and evaluation of vaccine safety issues, and coordinate activities to support these functions. We also will research studies to advance knowledge of vaccine safety and inform clinical and public health practices.
Investigator: Klein, Nicola
Funder: Centers for Disease Control and Prevention
Clinical Immunization Safety Assessment (CISA) IDIQ
We will provide clinical consultations to the CDC for vaccine safety cases, perform clinical case reviews and evaluation of vaccine safety issues, and coordinate activities to support these functions.
Investigator: Klein, Nicola
Funder: Centers for Disease Control and Prevention
Sexual health e-visit as a tool to improve access to prevention and treatment of sexually transmitted infections
This study will explore the role the sexual health e-visit plays in members’ access to sexual health services. The findings will inform future e-visit development within Kaiser Permanente Northern California and the use of similar platforms in other health care systems.
Investigator: Skarbinski, Jacek
Funder: TPMG Delivery Science Projects Program
Impact of gestational SARS-CoV-2 and maternal inflammation on child growth and neurodevelopment in a malaria-endemic setting
Leveraging longitudinal clinical data and samples from mother-infant dyads enrolled in two ongoing NIH-funded trials in Busia, Uganda, with high incidence of malaria and SARS-CoV-2, this study will evaluate the impact of gestational SARS-CoV-2 infection and vaccination on early childhood growth and neurodevelopment, and determine if the effect of gestational SARS-CoV-2 infection and vaccination on infant outcomes is mediated by specific maternal inflammatory pathways.
Investigator: Jacobson, Karen
Funder: National Institute of Allergy and Infectious Diseases
A Virtual Network to Investigate the Effectiveness of COVID-19 and influenza vaccines and evaluate the burden and epidemiology of respiratory viruses
This project’s core objectives are: 1) assessing COVID-19, influenza and RSV testing frequency, test type, and test results across age groups, care settings, disease severity, and population subgroups; 2) assessing COVID-19 and influenza VE across age groups, care settings, disease severity, and population subgroups; when RSV vaccines are available, evaluating RSV VE in eligible persons; 3) assessing COVID-19, influenza, and RSV vaccination coverage by dose number and product type; 4) describing the epidemiology and clinical characteristics of COVID-19, influenza, and RSV across age groups, care settings, disease severity, and population subgroups; 5) describing the trajectory of care for individuals with COVID-19, influenza, and RSV including severe outcomes and post-acute sequelae; and 6) assessing use of therapies for the treatment and prophylaxis for COVID-19, influenza, and RSV, and impact of these therapies in preventing illness and/or attenuating disease severity.
Investigator: Klein, Nicola
Funder: Centers for Disease Control and Prevention
Safety of Tetanus, Diphtheria, Acellular Pertussis with 5 Acellular Pertussis Components (Tdap5) Vaccination during Pregnancy: A Cohort Study using US Electronic Health Record Data
The primary objective of this study is to further evaluate the safety of Adacel vaccine among pregnant individuals exposed to Adacel during the third trimester of pregnancy and their offspring with regards to pre-defined pregnancy, birth, and neonatal outcomes.
Investigator: Klein, Nicola
Funder: Sanofi Pasteur S.A.
Multiregional partnership to evaluate cognitive impairment and dementia in older adults with HIV infection
The goal of this project is to establish a multiregional partnership to study cognitive impairment and dementia in people with HIV infection. We will launch this collaborative effort by constructing a research cohort for predictive modeling of dementia in the HIV setting, with data pooled from multiple Kaiser Permanente regions to increase diversity and ensure research findings accurately represent dementia risk across population subgroups. Our long-term vision is that this cohort will facilitate ongoing research on care delivery and outcomes related to dementia and aging in the growing population of older people with HIV infection.
Investigator: Lam, Jennifer
Funder: Garfield Memorial Fund
Cabotegravir PrEP: Actionable Robust Evidence for Translation into Practice (CABARET)
This study will characterize adoption, quantify impact, and determine cost-effectiveness of long-acting injectable HIV preexposure prophylaxis (LAI PrEP) to inform implementation strategies. We will evaluate implementation and impact of LAI PrEP in geographically and racially diverse areas of the U.S. with high HIV incidence and will include members of 3 regions of Kaiser Permanente: Northern California, Mid-Atlantic, and Georgia. Specific Aims include: 1) characterizing adoption and clinical outcomes of LAI PrEP in clinical practice; 2) quantifying the impact of LAI PrEP on HIV incidence and drug resistance; and 3) determining the cost-effectiveness of LAI vs. oral PrEP. The expected outcome of this study is actionable evidence on the adoption and projected impact of LAI PrEP in the first years of its availability, informing long-term implementation strategies for PrEP scale-up in the U.S.
Investigator: Silverberg, Michael
Funder: National Institute of Allergy and Infectious Diseases
A Prospective Observational Study to Evaluate the Safety of COVID-19 Vaccination in Children and Adolescents
Kaiser Permanente will recruit 20 participants (ages 5 to 16 years old) into the CISA COVID-19 Pediatrics study during the period of performance of (07/25/2022 through 9/2/2022).
Investigator: Klein, Nicola
Funder: Centers for Disease Control and Prevention
Optimizing identification of frailty among older adults with HIV infection
This study will: 1) describe the incidence, prevalence, and trends of frailty in people with and without HIV infection at Kaiser Permanente Northern California (KPNC), 2) quantify the contribution of sociodemographic, behavioral, and comorbidity-related factors to frailty, and 3) evaluate the use of an electronic health record-based frailty index to predict frailty-related clinical events. This study will be conducted in an established KPNC cohort of people with HIV and matched uninfected comparators.
Investigator: Lam, Jennifer
Funder: KP National Office of Community Health
Cervical Cancer Screening After Age 65 in the Era of HPV Testing: Estimating Benefits and Harms of Screening Cessation and Continuation
Although cervical cancer screening has been successful in the United States, little is known about the optimal circumstances under which screening can safely end. This study will address this research gap by estimating cervical cancer screening benefits and harms after age 65 in a large group of women enrolled in two large integrated healthcare systems in California. Using data from 2 KP regions (KPNC, KPSC), this study aims to: 1) determine whether cervical cancer incidence and mortality in individuals over age 65 varies by historical clinical factors used in guidelines for ending cervical cancer screening; 2) estimate cervical cancer screening benefits and harms in individuals over age 65; and 3) use cost-effectiveness analyses to identify the optimal criteria for ending cervical cancer screening in women.
Investigator: Silverberg, Michael
Funder: National Cancer Institute
Assessing Syndemics of Cardiovascular Disease in People with and without HIV
Cardiovascular disease (CVD) is a large and growing public health problem, especially for people with HIV (PWH). Within Kaiser Permanente, we use a syndemic approach to investigate combinations of social and biological conditions that may act synergistically to increase risk for of CVD in PWH, with a focus on the understudied conditions of mental health, substance use, economic factors, social isolation, stigma/discrimination, trauma history, and healthcare access challenges. This study will use Kaiser Permanente’s comprehensive electronic health record data, detailed Research Bank survey data, and stored serum to investigate the association of HIV status on Major Adverse Cardiovascular Events and preclinical biomarkers for cardiovascular disease. Study findings have potential to identify community- and health system-based CVD prevention interventions for vulnerable PWH.
Investigator: Silverberg, Michael
Funder: National Heart, Lung, and Blood Institute
Kaiser PrEP data
The purpose of this study is to initiate a 5-year collaboration between the Centers for Disease Control and Prevention (CDC) and 3 KP regions (KPNC, KPSC and KPMAS) to include PrEP prescription data and key demographics in the U.S. Department of Health and Human Service America’s HIV Epidemic Analysis Dashboard (AHEAD). This data will be used by the CDC to enhance existing surveillance, evaluation, and research activities in support of the federal Ending the HIV Epidemic in the U.S. Initiative.
Investigator: Silverberg, Michael
Funder: Centers for Disease Control and Prevention
A Phase IIIB, Randomized, Observer-blind, Multicenter Study to Assess the Safety and lmmunogenicity of GSK Meningococcal Group B Vaccine when Administered Concomitantly with GSK Meningococcal MenACWY Conjugate Vaccine to Healthy Subjects 16-18
This study will assess the safety and tolerability of rMenB+OMV NZ and MenACWY vaccines when administered concomitantly or alone in healthy subjects 16-18 years of age.
Investigator: Klein, Nicola
Funder: GlaxoSmithKline PLC
Pediatric COVID-19 Vaccination RCT in Young Children
We are providing technical expertise, consultation, and enrolling participants in a randomized clinical trial to evaluate the safety of simultaneous mRNA COVID-19 vaccine with other childhood vaccines in young children aged 6 months to 5 years.
Investigator: Klein, Nicola
Funder: Centers for Disease Control and Prevention
VSD Infrastructure
We conduct administrative tasks, data management, and contribute to vaccine safety assessments to support the management and development of the ongoing work of the VSD. This includes
producing and maintaining a high-quality electronic data infrastructure encompassing health plan members of
all ages that is accessible through a distributed data model.
Investigator: Klein, Nicola
Funder: Centers for Disease Control and Prevention
CEIP Post COVID Fatiguing Illness
This study aims to identify and characterize persons who are at risk of developing or who have developed post-COVID conditions, including those with medically unexplained illness in certain risk groups, and identify risk factors for post-COVID conditions.
Investigator: Skarbinski, Jacek
Funder: Centers for Disease Control and Prevention
Effectiveness of Adacel Vaccination in Pregnancy in Preventing Infant Pertussis
This observational cohort study will determine the effectiveness of the Adacel vaccine against pertussis disease in infants aged 2 months and 1 year when administered at any time during pregnancy.
Investigator: Klein, Nicola
Funder: Sanofi Pasteur S.A.
COVID-19 Vaccine Effectiveness in Pregnant Women and their Infants
The overall goals are to: Determine COVID-19 vaccine effectiveness in pregnant women for preventing laboratory-confirmed COVID-19 and hospitalization for COVID-19 using real-world clinical data; Determine effectiveness of maternal COVID-19 vaccination during pregnancy for infants 0-12 months for outcomes of laboratory-confirmed COVID-19, and hospitalization for COVID-19, and determine whether effectiveness varies by trimester of vaccination; Estimate COVID-19 vaccination rates among pregnant women and identify sociodemographic, geographic clusters and other factors associated with being unvaccinated.
Investigator: Zerbo, Ousseny
Funder: National Institute of Allergy and Infectious Diseases
An Expanded National Cohort Study of Transgender People
The Study of Transition, Outcomes and Gender (STRONG) is an ongoing cohort study of transgender people enrolled in Kaiser Permanente (KP) integrated health care plans in Georgia (KPGA), Northern California (KPNC) and Southern California (KPSC), and includes 6,459 members for years 2006 through 2014. In this study, we add a new site at Kaiser Permanente Mid-Atlantic States (KPMAS) and extend cohort members and follow-up through 2022. We will study acute cardiovascular events in relation to gender affirming testosterone (HT), characterize mental health status of transgender people, and evaluate changes in clinical health indicators in relation to HT receipt.
Investigator: Silverberg, Michael
Funder: National Institute on Aging
Monitoring shared variation in genomes of SARS-CoV-2 among persons with COVID-19 with and without vaccination in Northern California
We are studying the genomes of SARS-CoV-2 in persons with COVID-19 with and without vaccination to identify and describe variants circulating within our patients, including variants of concern (such as Delta or Omicron. We also are assessing which shared genomic variations are associated with a greater risk for infection (symptomatic and asymptomatic) and severe outcomes (such as hospitalization, intensive care unit use, and death), and whether certain subpopulations, such as those with certain medical comorbidities, might be at a greater risk for infection and severe outcomes from identified variants. Through modeling, we are investigating whether and which mutations result in decreased vaccine effectiveness for prevention of infection and severe outcomes, and which may require a booster or an updated vaccine.
Investigator: Skarbinski, Jacek
Funder: The Rockefeller Foundation
Tuberculosis Epidemiologic Studies Consortium III
This study will identify primary care systems and settings that serve non-U.S.-born persons at risk for latent tuberculosis infection (LTBI) and tuberculosis disease; collect retrospective and prospective electronic medical record data; design and implement clinical care-based interventions to improve performance measures across the LTBI care cascade; and monitor and evaluate intervention performance over time to identify efficient and effective strategies.
Investigator: Skarbinski, Jacek
Funder: Centers for Disease Control and Prevention
Electronic Health Record-Based Dementia Prediction for HIV Primary Care
The goal of this K01 Career Development Award is to receive mentored training on the development of risk prediction models for dementia in people with HIV using electronic health records data.
The project will quantify the contribution of HIV- and non-HIV-related factors to risk of dementia; develop and validate a model to predict incident dementia in people with HIV; and investigate strategies to optimize translation and implementation of research findings into clinical care settings.
Investigator: Lam, Jennifer
Funder: National Institute of Allergy and Infectious Diseases
Analysis to evaluate the effectiveness of a serogroup B outer membrane vesicle meningococcal vaccine against gonorrhea
The goal of this study is to use electronic medical records from 2016 to 2020 to evaluate the protective effect of MenB-4C vaccine against gonococcal infections among 16- to 23-year-old persons.
Investigator: Zerbo, Ousseny
Funder: Centers for Disease Control and Prevention
Comparing the frequency of SARS-CoV-2 variants of concern among vaccinated and unvaccinated COVID-19 cases
In partnership with the California Emerging Infection Program and the California Department of Public Health, Kaiser Permanente Northern California will contribute to statewide whole genome sequencing efforts for surveillance for SARS-CoV-2 variants of concern by submitting samples from all vaccine breakthrough cases, a subset of hospitalized cases, and a set of matched controls. Sequencing will be done in a central laboratory and sequence data reported to public health authorities.
Investigator: Skarbinski, Jacek
Funder: Centers for Disease Control and Prevention
(PQ3) Addressing Cancer Treatment Disparities for Persons with HIV
Cancer is the leading cause of death among persons with HIV (PWH). Studies have found significant disparities in cancer therapy initiation and survival for PWH compared with the general population. This study will evaluate differences in cancer treatment by HIV status and measure the impact of HIV status and patient-related risk factors on the rates of adverse events and long-term comorbidity and mortality.
Investigator: Silverberg, Michael
Funder: National Cancer Institute
A Phase 3 Master Protocol to Evaluate Additional Dose(s) of BNTJ 62b2 in Healthy Individuals Previously Vaccinated with BNTJ 62b2
This study will evaluate the safety, tolerability, and efficacy of a booster dose of BNT162b2 when administered to study participants who previously received 2 doses of BNT162b2 at least 6 months prior to randomization.
Investigator: Klein, Nicola
Funder: Pfizer Inc.
Long-term Outcomes Associated with Extended-Interval Dosing of the 9vHPV Vaccine: a Prospective, Observational Cohort Study Supplementary to V503-069 Clinical Trial
This prospective, observational cohort study, an extension of clinical trial V503-069, will enroll and administer a second dose of 9vHPV to approximately 200 children/teens ages 10 to 15 who received their first 9vHPV vaccine at least 1 year prior. These children/teens will be followed for 6 years via electronic medical record and e-survey to assess long-term outcomes associated with extended-interval dosing schedules on the incidence and prevalence of genital warts; assess reasons of non-compliance to the 9vHPV vaccine schedule; and assess the association between sexual behavior and genital warts.
Investigator: Klein, Nicola
Funder: Merck ＆ Company, Inc.
A Phase 3 International, Multicenter, Open-label Study to Evaluate the Safety and Immunogenicity of 9vHPV Vaccine Administered as 2-dose Regimen with Extended Dosing Intervals in 9- to 14-Year-Old Boys and Girls Compared with a Standard 3-dose
This study will evaluate extended 2-dose regimens in boys and girls ages 10 to 15 who previously received 1 dose of 9vHPV vaccine and did not complete the series and in HPV vaccine-naive boys and girls ages 9 to 14. Both groups will be compared with young women ages 16 to 26 who receive a standard 3-dose vaccine regimen.
Investigator: Klein, Nicola
Funder: Merck ＆ Company, Inc.
A Phase 1, Open-Label Dose-Finding Study to Evaluate Safety, Tolerability, and Immunogenicity Study of a Sars-Cov-2 RNA Vaccine Candidate Against Covid-19 in Healthy Children 12 Years of Age
This phase I open-label dose-finding study will evaluate the safety, tolerability, and immunogenicity of a Sars-Cov-2 RNA vaccine candidate against COVID-19 in healthy 12-year-old children.
Investigator: Klein, Nicola
Funder: Pfizer Inc.
Phase 3 Study to Evaluate the Lot Consistency, Safety, Tolerability, and Immunogenicity of the Vaccine Candidate BNT162b2 Against COVID-19 in Healthy Adults
To demonstrate that the immune responses induced by BNT162b2 are consistent across the 3 U.S. lots (Lots 1, 2, and 3) in participants without evidence of SARS-CoV-2 infection during the study.
Investigator: Klein, Nicola
Funder: Pfizer Inc.
Genome Sequencing Study, Flublock Quadrivalent Vaccine
Study will perform sequencing on 300 specimens from a mixture of Flublok Quadrivalent vaccine recipients, SD-IIV4 recipients, and unvaccinated individuals; and describe the molecular epidemiology of approximately 300 influenza strains causing disease in vaccinated (Flublok Quadrivalent vaccine and SD-IIV4) and unvaccinated individuals.
Investigator: Klein, Nicola
Funder: Sanofi Pasteur S.A.
COVID-19 Infrastructure and Activities Vaccine Safety Datalink Project
This work will support and contribute to the COVID-19 vaccine safety work of the VSD: managing site contributions, and participating on working groups and attending conference calls; providing high-quality electronic data for COVID-19 vaccine safety activities; participation on vaccine safety monitoring and evaluation studies; conducting medical record reviews.
Investigator: Klein, Nicola
Funder: Centers for Disease Control and Prevention
Phase 3 Study to Evaluate the Safety and Immunogenicity of 9vHPV Vaccine in 9- to 14-Year Old Boys and Girls
This study will evaluate extended 2-dose regimens in 2 different populations: (1) boys and girls 10 to 15 years of age who previously received 1 dose of 9vHPV vaccine and did not complete the series and (2) HPV vaccine-naive boys and girls 9 to 14 years of age compared with young women 16 to 26 years of age who receive a standard 3-dose vaccine regimen.
Investigator: Klein, Nicola
Funder: Merck ＆ Company, Inc.
Rapid Cycle Analysis for COVID-19 Vaccines in Vaccine Safety Datalink
We will develop a protocol, coordinate, and lead Rapid Cycle Analysis (RCA) activities in order to monitor the safety of COVID-19 vaccines in near real-time and investigate possible associations between the COVID-19 vaccines and a pre-specified list of adverse events for the Centers for Disease Control and Prevention.
Investigator: Klein, Nicola
Funder: Centers for Disease Control and Prevention
A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Conjugate Vaccine in Healthy Infants
This study is part of the Phase 3 pediatric clinical development program to evaluate the 20-Valent Pneumococcal Conjugate Vaccine for use in infants and children. This clinical trial will provide key safety and pivotal comparative immunogenicity data in infants to support licensure in this population.
Investigator: Klein, Nicola
Funder: Pfizer Inc.
SARS-CoV-2 Serological Antibody Testing for Disease Surveillance and Clinical Use
This study will assess the sero-prevalence and sero-incidence of SARS-CoV-2 infection in Kaiser Permanente Northern California and assess correlates of exposure and immunity among KPNC members.
Investigator: Skarbinski, Jacek
Funder: National Cancer Institute
A Phase 3 Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Remdesivir (GS-5734) Treatment of COVID-19 in an Outpatient Setting
This clinical trial will evaluate treatment with IV administered remdesivir in an outpatient setting in patients with COVID-19 who are at risk for disease progression.
Investigator: Skarbinski, Jacek
Funder: Gilead Sciences, Inc.
A Phase 1/2/3, Placebo-controlled, Randomized, Observer-blind, Dose-finding Study to Describe the Safety, Tolerability, Immunogenicity, and Potential Efficacy of SARS-Co V-2 RNA Vaccine Candidates Against COVID-19 in Healthy Adults
To describe the safety and tolerability profiles of prophylactic BNT162 vaccines in healthy adults after 1 or 2 doses
Investigator: Klein, Nicola
Funder: Pfizer Inc.
Innovative Methods to Inform Estimates of Vaccine Effectiveness Using Information on the Epidemiology and Incidence of Influenza and Other Acute Respiratory Illnesses
This study will estimate influenza vaccine effectiveness by vaccine type and for different ages by combining data from medical records, vaccine registries, and results of clinician-ordered molecular tests for influenza virus infection at Kaiser Permanente Northern California.
Investigator: Klein, Nicola
Funder: Centers for Disease Control and Prevention
Neurocognitive Impairment and Dementia in People With and Without HIV
People with HIV infection are at increased risk for dementia, possibly due to the combined effects of HIV-associated inflammation and traditional dementia risk factors such as chronic drug use and cerebrovascular disease. With the widespread use of antiretroviral therapy for HIV treatment, severe forms of HIV-associated dementia are now uncommon, but milder forms of neurocognitive impairment affect up to 50% of people living with HIV. In preparation for future investigations on cognitive impairments in people aging with HIV, we are conducting a study to establish baseline knowledge on: 1) The prevalence of neurocognitive impairment and dementia, and 2) Risk factors for neurocognitive disorders among Kaiser Permanente Northern California patients with and without HIV infection.
Investigator: Lam, Jennifer
Funder: Northern California Community Benefit Programs
Comparison of Cross-Sex Hormone Therapies in Relation to Risks of Vascular Events
The risk of acute thrombotic events such as venous thromboembolism (VTE) and ischemic stroke in transgender women receiving hormone therapy was addressed in our longitudinal Study of Transition, Outcomes & Gender (STRONG), supported by the Patient-Centered Outcomes Research Institute. STRONG is a cohort of transgender people enrolled in Kaiser Permanente’s Georgia, Northern California, and Southern California regions. This project found increased risk of VTE and ischemic stroke among transwomen treated with estrogen; however, the development of practical recommendations for the management of transwomen will require a more formal pharmacoepidemiologic analysis evaluating comparative risks of different hormone formulations, routes of administration, and doses. These data are available, but the definitive analyses were not possible due to sparse treatment-specific strata. To address these limitations, with this supplement we will include additional subjects identified at existing STRONG sites through the end of 2018 and extend follow up through mid-2019.
Investigator: Silverberg, Michael
Funder: Patient-Centered Outcomes Research Institute
A Phase 3 Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-Valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naive Adults 18 through 49 Years of Age
A phase 3, randomized, double-blind trial will evaluate the safety and immunogenicity of 3 lots of 20-valent Pneumococcal conjugate vaccine in Pneumococcal vaccine–naive adults 18 through 49 years of age. The purpose of this study is to evaluate the safety and consistency of immune response elicited across 3 different lots of 20vPnC.
Investigator: Klein, Nicola
Funder: ICON Clinical Research PLC
Mentoring Alcohol-Use Intervention Research in Health Care Settings
This research will examine the relationship of alcohol use and depression over time using data based in the electronic health record (EHR), in the context of health care. We will conduct secondary analysis of depression and hazardous drinking patterns in an HIV-positive patient alcohol intervention trial sample (n = 614). We will also examine use of EHR tools and other factors associated with reduction in hazardous drinking over time (e.g., use of patient portals and secure messaging) in order to develop additional EHR-assisted alcohol interventions.
Investigator: Silverberg, Michael; Satre, Derek
Funder: National Institute on Alcohol Abuse and Alcoholism
A Phase 3 Study to Evaluate the Safety and Tolerability of V114 in Healthy Infants (PNEU-LINK)
The primary objective of this study is to evaluate the safety and tolerability of V114 with respect to the proportion of participants with adverse events. Secondary objectives are:
1) To evaluate the anti-pneumococcal polysaccharide serotype-specific Immunoglobulin Geometric Mean Concentrations at 30 days following dose 3, prior to dose 4, and at 30 days following dose 4 for each vaccination group; and
2) To evaluate the anti-PnPs serotype-specific IgG response rates.
Investigator: Klein, Nicola
Funder: Merck ＆ Company, Inc.
Examining Vaccine Effectiveness of Flublok Relative to Standard Dose Inactivated Influenza Vaccine Among Kaiser Permanente Northern California Members Aged 18-64 Years
This study employs a cluster randomization design to examine the vaccine effectiveness of Flublok relative to that of other flu vaccines used at Kaiser Permanente Northern California over two influenza seasons (2018 to 2019 and 2019 to 2020), in Kaiser Permanente Northern California members aged 18 to 64 years (comparator vaccines will not include high-dose or live vaccines). The primary age group of interest is 50- to 64-year-olds. Primary outcomes may include: 1) an influenza diagnosis confirmed by polymerase chain reaction (PCR) test as positive for influenza (A or B), 2) hospitalization with a PCR-confirmed influenza diagnosis regardless of the principal discharge diagnosis, and 3) hospitalization for pneumonia in December through March (regardless of whether there is a PCR test). Secondary outcomes may include other flu-related events, such as cardiovascular events (e.g., myocardial infarction or stroke) and other respiratory outcomes.
Investigator: Klein, Nicola
Funder: Protein Sciences Corporation
Shingrix Lead Site Evaluating the Effectiveness of Recombinant Zoster Vaccine
The purpose of this project is, first, to estimate the proportion of the population under study receiving one and two doses of recombinant zoster vaccine (RZV). Second, among live zoster vaccine (ZVL)-naive persons, this study aims to: 1) estimate the vaccine effectiveness of one dose of RZV, 2) estimate the vaccine effectiveness of two doses of RZV in 50- to 64-year-olds and those aged 65 and above, and 3) calculate the incremental vaccine effectiveness of a complete series (two-dose vaccine effectiveness versus one-dose vaccine effectiveness). Lastly, this study aims to estimate the vaccine effectiveness of one-dose RZV and of two-dose RZV among persons who previously received ZVL, as well as among immunocompromised persons.
Investigator: Klein, Nicola
Funder: Centers for Disease Control and Prevention
Effect of Maternal Influenza Vaccination during Pregnancy on Risk of Infant Influenza
This project has three major aims: 1) to examine whether influenza vaccination during pregnancy prevents influenza and other respiratory infections in infants aged 0 to 12 months, with a sub-aim to examine the effect of vaccine timing during pregnancy on these outcomes; 2) to evaluate the effect of maternal influenza vaccination during pregnancy on the effectiveness of influenza vaccine administered to infants; and 3) to examine whether influenza non-vaccination during pregnancy clusters geographically, and determine if those clusters are associated with influenza and influenza-like illnesses during pregnancy.
Investigator: Zerbo, Ousseny
Funder: National Institute of Allergy and Infectious Diseases
A Phase IIIB Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine when Administered Concomitantly with Routine Vaccines to Healthy Infants
This is a phase IIIB, observer-blind, randomized, placebo-controlled, multi-center study to assess the safety and immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine when administered concomitantly with routine vaccines to healthy infants
Investigator: Klein, Nicola
Funder: GlaxoSmithKline PLC
Statistical Analysis Studies Comparing Flucelvax to Egg-Based Influenza Vaccinations
This study has three primary aims: 1) to estimate the relative vaccine effectiveness of Flucelvax versus inactivated influenza vaccine (IIV) in vaccinated Kaiser Permanente Northern California members aged 4 to 64 years against all PCR-confirmed influenza A5; 2) to estimate the vaccine effectiveness of Flucelvax against all PCR-confirmed influenza A, comparing Flucelvax vaccinees versus unvaccinated in Kaiser Permanente Northern California members aged 4 to 64 years; and 3) to estimate the vaccine effectiveness of IIV (not including Flucelvax) against all PCR-confirmed influenza A, comparing IIV vaccinees versus unvaccinated Kaiser Permanente Northern California members aged 4 to 64 years. Secondary aims are 1) to estimate the relative vaccine effectiveness of Flucelvax versus trivalent influenza vaccine (TIV) in vaccinated Kaiser Permanente Northern California members aged 4 to 64 years against all PCR-confirmed influenza B; and 2) to estimate the relative vaccine effectiveness of Flucelvax versus IIV in vaccinated Kaiser Permanente Northern California members aged 4 to 64 years against PCR-confirmed hospitalized influenza A.
Investigator: Klein, Nicola
Funder: Shoo the Flu, LLC
A Continuation of Assessment of the Impact of Prevnar 13 on Invasive Pneumococcal Disease Caused by Vaccine Serotypes of Streptococcus pneumoniae After Introduction Into Routine Pediatric and Adult Use for the Period of May 2015 – April 2020
This project will estimate Prevnar 13 (PCV13) vaccine effectiveness against invasive pneumococcal disease using a test-negative design in the Kaiser Permanente Northern California adult population from September 1, 2014, through December 31, 2017. Positive cases will be defined as patients with invasive pneumococcal disease where serotype 3 is identified. Test-negative controls will be defined as patients with invasive pneumococcal disease where a non-PCV serotype is identified. As a sensitivity analysis, the vaccine effectiveness of Prevnar 13 against invasive pneumococcal disease caused by serotype 3 will also be compared with the vaccine effectiveness of 23-valent pneumococcal polysaccharide vaccine (PPV23) serotypes against invasive pneumococcal disease. In addition, invasive pneumococcal disease cases will be compared with the entire Kaiser Permanente Northern California adult population with similar characteristics matched on age, race, sex, and calendar time to better understand vaccination rates among different serotypes.
Investigator: Klein, Nicola
Funder: Pfizer Inc.
Safety of Direct Acting Antiviral Medications for Hepatitis C
This project will identify all patients who have a laboratory-confirmed diagnosis of Hepatitis C. The intervention group will be those who had a prescription filled for a new antiviral medication after October 10, 2014, and who were naive to treatment for Hep C prior to the prescription. The comparison group will be those who have not been treated for Hep C. Incidence of the following types of adverse events will be measured: acute or acute-on-chronic or uncertain cause liver failure (including liver transplant), acute kidney failure, myocardial infarction, liver cancer, multiple organ failure, stroke, and death. For liver failure in particular, a chart review will be conducted to validate the outcome. The initial analysis will use a Poisson model that includes exposure time (time to adverse event or censoring event). Other analytic methods may be employed to address channeling by indication.
Investigator: Silverberg, Michael
Funder: Patient-Centered Outcomes Research Institute
HIV Infection, Use of Tenofovir and Other Antiretrovirals, and Risk of Fatal and Non-Fatal Comorbidities: Cohort Study in Kaiser Permanente
Although the benefits of combination antiretroviral therapy (ART) for reducing HIV-related morbidity and mortality are well-recognized, toxicity from some ART may potentially contribute to excess age-related comorbidities. Certain antiretrovirals, including tenofovir, have known renal toxicity, but recent formulations may be associated with improved outcomes. Tenofovir-based ART is also increasingly used in high-risk HIV-uninfected individuals for HIV preexposure prophylaxis (PrEP), although the long-term health outcomes are unknown. The goal of this study is to characterize the incidence and predictors of key fatal and non-fatal comorbidities in HIV patients, and in demographically similar comparison groups of HIV-uninfected patients, including a general population sample, and HIV-uninfected individuals prescribed PrEP. This research will be conducted in approximately 39,000 HIV-infected and 390,000 HIV-uninfected subjects from Kaiser Permanente Northern California, Kaiser Permanente Southern California, and Kaiser Permanente of the Mid-Atlantic States.
Investigator: Silverberg, Michael
Funder: Gilead Sciences, Inc.
A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants
Investigator: Klein, Nicola
Funder: ICON Clinical Research PLC
Continuation of Group B Streptococcus Epidemiology Study (Phase II)
Kaiser Permanente Northern California has recently collaborated with Pfizer in identifying invasive and noninvasive group B streptococcus (GBS) disease burden in adults during a seven-year time period spanning 2007 to 2014. In Phase 1 of this research collaboration, comorbid medical conditions in subjects with GBS disease were identified. In Phase 2 of this research collaboration, the burden of invasive and/or noninvasive GBS disease among subjects with the most commonly identified medical conditions identified in Phase 1 will be evaluated. These data will inform potential future study populations for the evaluation of a GBS vaccine in adults. The objective is to identify populations at highest risk for GBS disease (invasive and noninvasive) based on the pre-specified medical conditions and age groups from the Phase 1 analyses. Prediction models for patient risks of GBS will be developed, and with the models, each risk factor and combination of risk factors will be evaluated.
Investigator: Klein, Nicola
Funder: Pfizer Inc.
Safety of Direct-Acting Antiviral Medications for Hepatitis C
This study will investigate the safety of direct-acting antiviral medications in patients who have a laboratory-confirmed diagnosis of hepatitis C. The intervention group will be those who had a prescription filled for a new antiviral medication after October 10, 2014. The comparison group will be those who have not been treated for hepatitis C. Incidence of the following types of adverse events will be measured: acute or acute-on-chronic or uncertain-cause liver failure (including liver transplant), acute kidney failure, myocardial infarction, liver cancer, multiple organ failure, stroke, and death. For liver failure in particular, a chart review will be conducted to validate the outcome. Initial analysis will use a Poisson model that includes exposure time (time to adverse event or censoring event). Other analytic methods may be employed to address channeling by indication.
Investigator: Silverberg, Michael
Funder: Patient-Centered Outcomes Research Institute
Predictors of Pneumococcal Vaccination, Pneumococcal Vaccine Effectiveness, and Trends in Pneumonia
The three objectives of this study are to: 1) Identify and compare the clinical, demographic and neighborhood characteristics associated with receipt of pneumococcal vaccine among persons 65 years of age and older, and among persons 18 to 64 years of age with risk conditions (at-risk and high-risk); 2) Estimate the effectiveness of 13-valent pneumococcal conjugate vaccine (PCV13) and 23-valent pneumococcal polysaccharide vaccine (PPSV23) in preventing health care utilization for invasive pneumococcal disease, lower respiratory tract infections, and all-cause pneumonia in persons 18 to 64 years of age and in persons 65 years of age and older; and 3) Identify cases of all-cause pneumonia and lower respiratory tract infections , and describe trends in the incidence of health care services utilization under different definitions in persons 18 to 64 years of age with risk conditions (at-risk and high-risk) and in persons 65 years of age and older in the Kaiser Permanente Northern California population.
Investigator: Klein, Nicola
Funder: Pfizer Inc.
California Emerging Infections Program
The goal of this project is to determine the age-specific rates of laboratory-confirmed influenza-associated hospitalization among children, and to describe clinical and epidemiologic characteristics of pediatric hospitalized case-patients during the influenza season.
Investigator: Klein, Nicola
Funder: Centers for Disease Control and Prevention
Extension of the Consortium to improve OutcoMes in HIV/Aids, Alcohol, Aging & multi-Substance (COMpAAAS)
With support from the National Institute on Alcohol Abuse and Alcoholism, the Consortium to improve OutcoMes in HIV/Aids, Alcohol, Aging & multi-Substance (COMpAAAS) has analyzed data from patients in the Veterans Administration Cohort Study. This project seeks to extend this consortium to include Kaiser Permanente and the antiretroviral therapy cohort collaboration at the University of Bristol as new partners to increase sample diversity and representation of people living with HIV. The primary goals of the study are to evaluate the risk of alcohol and tobacco exposure on mortality, hospitalizations, comorbidities, and physiologic frailty for people living with HIV and matched HIV-uninfected controls. Each of the collaborating sites will share aims and study protocols, and will coordinate data management, statistical analysis, and reporting of results to increase sample size, include diverse populations, enhance comparability and generalizability, and maximize impact, as well as utilize resources efficiently.
Investigator: Silverberg, Michael; Satre, Derek
Funder: National Institute on Alcohol Abuse and Alcoholism
Hosting a Hub Server for the Vaccine Safety Datalink
The hub server is used to transfer programs and related files to Vaccine Safety Datalink (VSD) sites from the Centers for Disease Control and Prevention (CDC), and to transfer output from these programs back to CDC. The hub provides a common point that can be accessed by both CDC and participating VSD sites. The purpose of the hub is to provide a secure centralized location to transfer programs and output between CDC and the VSD sites.
Investigator: Klein, Nicola
Funder: Centers for Disease Control and Prevention
A Phase 3, Randomized Study of a Two-Dose Bivalent Rlp2086 Regimen and a First-In-Human Study of the MenABCWY Vaccine
This study is a phase 3, randomized, active-controlled, observer-blinded study to assess the immunogenicity, safety, and tolerability of bivalent rLP2086 when administered as a two-dose regimen in healthy subjects 10 to 26 years of age. The project also includes a first-in-human study to describe the immunogenicity, safety, and tolerability of a bivalent rLP2086-containing pentavalent vaccine (MenABCWY) in healthy subjects 10 to 26 years of age.
Investigator: Klein, Nicola
Funder: Pfizer Inc.
Clinical Immunization Safety Assessment (CISA), 1) Clinical Evaluation Activities and 2) Rapid Assessment of Post-Immunization Data (RAPID) Project
The purpose of this project is to provide the Centers for Disease Control and Prevention (CDC) Immunization Safety Office with an as-needed mechanism to obtain required services through the issuance of individual task orders in support of vaccine safety monitoring and evaluation that meet public health priorities for CDC. The CISA clinical consulting activity covers two CISA goals: a) To serve as a vaccine safety resource for consultation on clinical vaccine safety issues, including individual case reviews, and assist with immunization decision-making; and b) To assist CDC in developing strategies to assess individuals who may be at increased risk for adverse events following immunization. The purpose of the Rapid Assessment of Post-Immunization Data (RAPID) project is to conduct case-centered method analyses to assist with assessments of causality of adverse events following immunization.
Investigator: Klein, Nicola
Funder: Centers for Disease Control and Prevention
Optimizing Lung Cancer Treatment in HIV Infected Persons
Lung cancer is now a leading cause of death in HIV infected persons. Lung cancer survival is worse in HIV infected persons, in part due to uncertainty regarding the optimal treatment pathways for this group. In this project we will use data from several large, representative HIV cohorts to calibrate a well-validated, biologically-based simulation model of lung cancer (the Lung Cancer Policy Model) to determine the lung cancer treatments that offer the best life expectancy and quality-of-life for HIV infected lung cancer patients.
Investigator: Silverberg, Michael
Funder: National Cancer Institute
A phase IIIA, randomized, single-blind, multi-centric study to evaluate the immunogenicity, reactogenicity and safety of three doses of Pediarix, Hiberix and Prevenar 13
A phase IIIA, randomized, single-blind, multi-centric study to evaluate the immunogenicity, reactogenicity and safety of three doses of Pediarix, Hiberix and Prevenar 13 when co-administered with two doses of the PCV-free liquid formulation of GSK Biologicals oral live attenuated HRV vaccine as compared to the currently licensed lyophilized formulation of the HRV vaccine in healthy infants 6-12 weeks of age.
Investigator: Klein, Nicola
Funder: GlaxoSmithKline PLC
Safety Research of Currently Recommended Immunizations: Identifying Genetic, Immunologic and Clinical Factors Predisposing to Adverse Events after MMR Vaccine
The aims of this study are: 1) To determine genetic factors and immunologic patterns that may predict the occurrence of fever after measles vaccines by analyzing previously collected biospecimens during a randomized controlled MMR clinical trial. 2) To investigate for a familial clinical phenotype that predicts fever after MCV using KPVSC’s large pregnancy database to assess whether parental clinical risk factors are associated with fever in the child.
Investigator: Klein, Nicola
Funder: Office of the Assistant Secretary for Health
Effectiveness and safety of interferon-free treatment for hepatitis C virus (HCV) infection in a clinical practice setting
This a cohort study of KPNC patients initiating interferon-free treatment for HCV infection, with the following specific aims: 1) Determine the short- and long-term effectiveness of interferon-free treatment for HCV infection, 2) determine the safety of interferon-free treatment for HCV infection, and 3) compare the effectiveness and safety of 8- versus 12-week interferon-free treatment for HCV infection. Our results will guide clinical decision-making to maximize the effectiveness and safety of HCV treatment for KPNC patients.
Investigator: Silverberg, Michael
Funder: The Permanente Medical Group
A prospective, epidemiological, interventional, multi-country based, cohort study to assess the disease burden of respiratory syncytial virus (RSV) associated, suspected lower respiratory tract infections (LRTIs) in newborns, etc.
A prospective, epidemiological, interventional, multi-country based, cohort study to assess the disease burden of respiratory syncytial virus (RSV) associated, suspected lower respiratory tract infections (LRTIs) in newborns, etc.
Investigator: Klein, Nicola
Optimizing Cardiovascular Risk Prediction in HIV
The objective of this study is to develop methods to accurately predict cardiovascular disease (CVD) risk for HIV patients. CVD risk is increased for HIV patients, yet accurate methods for risk prediction remain unclear. We will evaluate the performance of the Framingham Risk Score (FRS) and the ACC/AHA risk prediction algorithm among HIV patients and generate new CVD risk prediction algorithms incorporating HIV and HIV-related factors to assess whether risk prediction can be improved for this population. The HIV-specific CVD risk prediction algorithms will be generated in collaboration with Framingham Heart Study investigators using an HIV clinical care cohort from the Partners HealthCare System and will be externally validated using the Kaiser Permanente Northern California (KPNC) HIV cohort. The ability to accurately risk-stratify HIV patients will ensure that the highest risk patients receive appropriate treatment and will directly impact long-term HIV care strategies.
Investigator: Silverberg, Michael
Funder: National Heart, Lung, and Blood Institute
A Phase II, Double-Blind, Randomized, Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 Compared to Prevnar13 in Healthy Infants
A phase II, double-blind, randomized, multicenter study to evaluate the safety, tolerability, and immunogenicity of V114 compared to Prevnar13 in healthy infants.
Investigator: Klein, Nicola
Funder: Merck ＆ Company, Inc.
A Phase 3, Placebo-Controlled, Randomized, Observer-Blinded Study to Evaluate the Efficacy, Safety and Tolerability of a Clostridium Difficile Vaccine in Adults 50 Years of Age and Older
Pfizer’s investigational Clostridium difficile vaccine (PF-06425090) is a prophylactic vaccine that is currently being investigated for the prevention of primary C difficile infection in adults 50 years of age and older.
Investigator: Klein, Nicola
Funder: Pfizer Inc.
Impact of Eliminating Non-Medical Exemptions in California
The goal of this study is to develop an evidence base for the implementation of immunization legislation relating to exemptions. We will achieve this goal by addressing four specific aims: 1) Analyze rates, clustering and variances of immunization exemptions and conditional entrants before and after implementation of SB277; 2) Evaluate health care providers motivations, attitudes, beliefs and health care practice burden relating to vaccinations in the context of SB277; 3) Assess the determinants and implications of variability in implementation and enforcement of legislation at the school level; and 4) Ascertain the impact of SB277 on the rates of home schooling.
Investigator: Klein, Nicola
Funder: National Institute of Allergy and Infectious Diseases
Post-Marketing Observational Study of Safety Following Vaccination with Flublok Compared to Licensed IIV in Adults 18 Years of Age and Older
Post-marketing observational study of safety following vaccination with Flublok compared to Licensed IIV in adults 18 years of age and older.
Investigator: Klein, Nicola
Funder: Protein Sciences Corporation
A Phase III, Open Label, Multicenter Study of GSK Biological Herpes Zoster HZ/su Candidate Vaccine
A phase III, open label, multicenter study of GSK Biological herpes zoster HZ/su candidate vaccine (GSK1437173A) administered intramuscularly on a 0 and 2 month schedule evaluating the immunogenicity, safety and reactogenicity in adults 65 years of age with a previous Zostavax vaccination 5 years earlier, compared to group-matched adults not previously vaccinated with Zostavax.
Investigator: Klein, Nicola
Funder: GlaxoSmithKline PLC
HIV Status and Incidence and Outcomes of Heart Failure
Antiretroviral therapy (ART) has prolonged the lifespan of HIV-infected patients, resulting in a growing number of individuals aging with HIV infection. As this population ages, comorbidities, such as cardiovascular disease have increasingly contributed to excess morbidity and mortality. Unlike acute myocardial infarction, heart failure incidence is increasing in the general population, with associated serious morbidity and excess mortality, but has received less attention in the HIV population. Leveraging the Cardiovascular Research Network’s Heart Failure consortium, our study goals are: 1) To characterize the association of HIV status with the incidence of heart failure; 2) Among HIV-infected patients, to evaluate the effect of ART use, CD4 and HIV viral replication on the incidence of heart failure; and 3) To examine the influence of HIV status on heart failure-related treatment patterns, hospitalizations and death among incident heart failure patients.
Investigator: Silverberg, Michael
Funder: National Heart, Lung, and Blood Institute
HPV Vaccine Impact Study
The California Emerging Infections Program will collaborate with the California Department of Health Services to develop a comprehensive plan to conduct systematic population-based cervical intraepithelial neoplasia surveillance and implement a pilot project in Alameda County. This population-based surveillance project aims to monitor the impact of the HPV vaccine on cervical cancer precursor lesions.
Investigator: Silverberg, Michael
Funder: Centers for Disease Control and Prevention
Post-Licensure Observational Safety Study of Gardasil 9
In December 2014, the FDA approved the Human Papillomavirus (HPV) 9-valent vaccine, Gardasil 9, for use in young males (9-15 years of age) and females (9-26 years of age). While clinical trials in large populations have shown that Gardasil 9 is generally safe and well tolerated, this observational study is being conducted by Merck and Co., Inc. as a post-licensure regulatory commitment to the FDA to monitor the general safety of Gardasil 9 when administered as part of routine health care.
Investigator: Klein, Nicola
Funder: Merck ＆ Company, Inc.
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety And Efficacy of Staphylococcus Aureus 4-Antigen Vaccine (Sa4ag) in Adults Undergoing Elective Posterior Instrumented Lumbar Spinal Fusion Procedures
Clinical trial of staphylococcus aureus 4-Antigen vaccine.
Investigator: Klein, Nicola
Funder: inVentiv Health Clinical, LLC
HIV Drug Resistance Mutation as Predictors of Clinical Outcome
In collaboration with KPNC clinicians and investigators, Stanford performs research investigations regarding the relationship of HIV resistance, antiretroviral therapy and clinical outcomes, including CD4 and HIV RNA response.
Investigator: Silverberg, Michael
Funder: Stanford University
A Post Marketing Safety Study of Q/LAIV in Subjects 2 through 49 Years of Age
Investigator: Klein, Nicola
Funder: MedImmune, LLC
Identifying Target Populations for an Investigational C. difficile Vaccine
C. difficile-associated disease’s (CDAD) clinical importance and its increasing incidence have resulted in C. difficile being a target for vaccine development. However, questions regarding which population may most benefit from receipt of a C. difficile vaccine remain. While CDAD is known to be associated with hospitalization, limited information exists regarding the burden of disease in specific populations such as those with underlying medical conditions. Further, the burden disease among those in long term care facilities and those in the outpatient setting is not well understood. The overall goal of this study is to identify potential at-risk groups which could be targeted to receive an investigational preventative C. difficile vaccine as part of a Phase 3 clinical trial.
Investigator: Klein, Nicola
Funder: Pfizer Inc.
A Phase 3b, Controlled, Open-Label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Single Dose of GSKs Meningococcal ACWY Conjugate Vaccine, Admin to Healthy Individuals 15 – 55 years of age, approx. 4-6 years after vaccination
A Phase 3b, Controlled, Open-Label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Single Dose of GlaxoSmithKlines Meningococcal ACWY Conjugate Vaccine (Menveo), Administered to Healthy Individuals 15 through 55 years of age, approximately 4-6 years after primary ACWY vaccination, 205352 (V59_77).
Investigator: Klein, Nicola
Funder: GlaxoSmithKline PLC
A phase III, open label, multicenter study to evaluate the impact of reactogenicity on Quality of Life (QoL), after intramuscular administration of GSK Biologicals candidate Herpes Zoster subunit (HZ/su) vaccine in adults 50 years of age
A phase III, open label, multicenter study to evaluate the impact of reactogenicity on Quality of Life (QoL), after intramuscular administration of GSK Biologicals candidate Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A) in adults 50 years of age.
Investigator: Klein, Nicola
Funder: GlaxoSmithKline PLC
Health Outcomes and Healthcare Resource Utilization Associated with Mild versus Moderate-to-Severe Laboratory-Confirmed Influenza in a Retrospective Cohort of US Children
This study will evaluate differences in health outcomes and healthcare resource utilization between moderate-to-severe influenza compared to mild influenza as defined by Jain et al 2013 in children aged 6 to 35 months in the US. Secondary objectives: To evaluate differences in health outcomes and healthcare resource utilization between moderate-to-severe influenza compared to mild influenza as defined by Jain et al 2013 in children aged 6 months to 18 years in the US, and to evaluate differences in health outcomes and healthcare resource utilization between moderate-to-severe influenza compared to mild influenza as defined by Jain et al 2013 in children aged 6 to 12 months in the US.
Investigator: Klein, Nicola
Funder: GlaxoSmithKline PLC
Retrospective Cohort Study of Staphylococcus Aureus Surgical Site Infections in Patients Undergoing Elective Surgical Procedures in Kaiser Permanente Northern California (KPNC) Integrated Health System
This project will expand enrollment in an ongoing Staph vaccine trial. This will descriptive analyses of Staph infections following multiple types of surgeries, and risk factors associated with infection.
Investigator: Klein, Nicola
Funder: Pfizer Inc.
Surgical Site Infection Rates for Patients Undergoing Elective Posterior Lumbar Spinal Fusion Surgery in Kaiser Permanente Northern California Hospitals
Surgical site infection rates for patients undergoing elective posterior lumbar spinal fusion surgery in Kaiser Permanente Northern California hospitals.
Investigator: Klein, Nicola
Funder: Pfizer Inc.
Beta Hemolytic Streptococcal Infections in a Managed Care Population
Beta Hemolytic Streptococcal Infections in a Managed Care Population
Investigator: Klein, Nicola
Funder: Pfizer Inc.
Implementing Computerized Substance Use and Depression Screening and Evidence-Based Treatments in an HIV Primary Care Population
This proposal will develop and test the delivery of integrated, sustainable, evidence-based interventions to improve health outcomes of people living with HIV with substance use disorders (SUDs). The intervention will be delivered in advance of routine health care visits, and aims to systematize SUD screening aided by use of patient portals, within several large HIV clinics in KPNC. Outcomes of interest include ongoing substance use, linkage with primary-care-based SUD-services, antiretroviral therapy adherence and response, and comorbidities linked to both SU and HIV.
Investigator: Silverberg, Michael
Funder: National Institute on Drug Abuse
HPV Impact Typing Study (HiTS) part II, 2015-2017
This is a follow-up study of of a previous study which evaluated HPV type prevalence in residual cervical specimens from screening. The current study will measure the impact of HPV typing ollowing the introduction of the human papillomavirus vaccine. This study will collect leftover Pap specimens from the clinical lab and sending them to CDC for HPV typing.
Investigator: Klein, Nicola
Funder: Centers for Disease Control and Prevention
Post-licensure Safety Surveillance Study of Menactra Vaccine When Administered as a 2-dose Schedule to Children 9 Months Through 23 Months of Age (MTA57)
In this project, we will conduct a case-control genome-wide association study to evaluate the human genome of who experienced a febrile seizure (FS) 7-10 days after a measles-containing vaccine, including MMRV and MMR given either alone or concomitantly with varicella vaccine in order to identify genetic risk factors associated with fever and FS.
Investigator: Klein, Nicola
Funder: Sanofi Pasteur S.A.
Post-Licensure Evaluation of the Long-Term Effectiveness of ZOSTAVAX
This study consists of data collection on patients receiving treatment with Prevnar (13vPnC) as part of their standard medical care.
Investigator: Klein, Nicola
Funder: Merck ＆ Company, Inc.
Incidence of Group A Beta Hemolytic Streptococcus Pharyngitis in Children and Group A, B, C and G Invasive Streptococci Disease in Adults Older than 65 years of Age: A Six Year Retrospective Surveillance Study (2004-2009)
This study consists of data collection on patients receiving treatment with Prevnar (13vPnC) as part of their standard medical care.
Investigator: Klein, Nicola
Funder: Pfizer Inc.
Evaluation of Waning Protection Against Pertussis Following GSK DTaP Vaccines
California, including the Kaiser Permanente Northern California (KPNC) population area, experienced the largest pertussis outbreak in more than 50 years during 2010-2011.This study will assess the durability of protection against pertussis in children who received 5 doses of DTaP vaccines made by GlaxoSmithKline, a major producer of vaccines in the US and globally. The primary objective is to assess waning protection against pertussis following 5 doses of DTaP among children who received all GSK pertussis vaccines.
Investigator: Klein, Nicola
Funder: GlaxoSmithKline PLC
Postlicensure Observational Safety Study of 13 Valent Pneumococcal Conjugate Vaccine Administered in Routine Use to Infants and Toddlers
This study is non-interventional and consists of data collection on patients receiving Pfizer product Prevnar 13.
Investigator: Klein, Nicola
Funder: Pfizer Inc.
A Postmarketing Observational Study Estimating the Impact of Prevnar 13 (13vPnC) on Invasive Pneucoccal Disease Caused by Vaccine of Streptococcus pneumoniae After Introduction into Routine Pediatric Use
This study is non-interventional and consists of data collection on patients receiving treatment with the Pfizer product Prevnar (13vPnC) as part of their standard medical care.
Investigator: Klein, Nicola
Funder: Pfizer Inc.
Antiretroviral Therapy Strategies to Lower Cancer Risk in HIV-Infected Persons
The overarching goal of this study is to formulate evidence-based recommendations about the preferred CD4 T-cell count at which to initiate antiretroviral therapy (ART), and the preferred initial ART regimen, that would minimize cancer incidence among HIV-infected persons.
Investigator: Silverberg, Michael
Funder: National Cancer Institute
Using Comparative Effectiveness Analyses to Optimize Cervical Cancer Screening
The overall goal of this study is to identify optimal cervical cancer screening strategies that minimize associated screening harms, while maximizing benefits. The approach will use decision analytic models and comparative effectiveness analyses to identify novel screening strategies that provide similar benefits and harms, resulting in a range of options for cervical cancer screening, which might vary by individual risk factors.
Investigator: Silverberg, Michael
Funder: National Cancer Institute
Fever in Young Children after Simultaneous Versus Sequential Vaccination with Inactivated Influenza Vaccine (IIV) and PCV13/DTaP Vaccines
The purpose of this project is to provide the Centers for Disease Control and Prevention (CDC), Immunization Safety Office, an as needed mechanism to obtain required services through the issuance of individual task orders in support of vaccine safety monitoring and evaluation that meet public health priorities for CDC. Work performed will be based on the following technical requirements: Clinical Immunization Safety Assessment (CISA) project will be a resource to address clinical vaccine safety issues and provide a public health service to the nation. The project will also contribute to or conduct studies to answer questions about why certain individuals experience adverse events following immunization (AEFI), that are believed to be causally linked to vaccines, and how to prevent them. Results from such studies shall provide evidence to better inform vaccination practices.
Investigator: Klein, Nicola
Funder: Centers for Disease Control and Prevention
Autoimmune disease risk following quadrivalent HPV vaccine/Prevention and Public Health Funds (PPHF)
Quadrivalent human papillomavirus vaccine (HPV4) is recommended for males and females 9-26 years of age. Pre-licensure trials for HPV4 did not find an imbalance of autoimmune diseases between study arms, however, associations between rare adverse events and the vaccine in these trials were difficult to detect due to limited sample sizes. Many autoimmune diseases manifest during the young adult years; it is important to assess if there is an increased risk of incident autoimmune disease following HPV4, which is recommended just before adolescence.
Investigator: Klein, Nicola
Funder: Centers for Disease Control and Prevention
North America AIDS Cohorts Collaboration on Research and Design (NA-ACCORD)
The NA-ACCORD is a consortium of HIV cohorts across U.S. and Canada endeavoring to address major HIV-related clinical and epidemiologic questions that cannot be addressed through smaller studies. Dr. Silverberg is leading the HIV and Cancer research efforts in NA-ACCORD.
Investigator: Silverberg, Michael
Funder: National Institute of Allergy and Infectious Diseases
