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Infectious Diseases Studies

 

Rapid Cycle Analysis for COVID-19 Vaccines in the VSD

The Vaccine Study Center (VSC) will develop a protocol, coordinate and lead Rapid Cycle Analysis activities to monitor the safety of COVID-19 vaccines in near real-time. Through near-real time monitoring the VSC will identify and investigate possible asso...
Funder: Centers for Disease Control and Prevention
Investigator: Klein, Nicola

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
Funder: Pfizer Inc.
Investigator: Klein, Nicola

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...
Funder: Centers for Disease Control and Prevention
Investigator: Klein, Nicola

Neurocognitive Impairment and Dementia in People With and Without HIV

People with HIV are at increased risk for dementia due to the combined effects of HIV-associated inflammation and traditional (non-HIV) risk factors such as chronic drug use and cerebrovascular disease. With the widespread use of antiretroviral therapy fo...
Funder: Northern California Community Benefit Programs
Investigator: Lam, Jennifer

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-Centere...
Funder: Patient-Centered Outcomes Research Institute
Investigator: Silverberg, Michael

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 sa...
Funder: ICON Clinical Research PLC
Investigator: Klein, Nicola

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 ...
Funder: National Institute on Alcohol Abuse and Alcoholism
Investigator: Satre, Derek; Silverberg, Michael

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 Imm...
Funder: Merck & Company, Inc.
Investigator: Klein, Daniel; Klein, Nicola

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 and Gender (STRONG). STRONG is a cohort of transgen...
Funder: Patient-Centered Outcomes Research Institute
Investigator: Silverberg, Michael

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 Pe...
Funder: Protein Sciences Corporation
Investigator: Klein, Nicola

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 vac...
Funder: Centers for Disease Control and Prevention
Investigator: Klein, Nicola

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. Positiv...
Funder: Pfizer Inc.
Investigator: Klein, Nicola

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...
Funder: Shoo the Flu, LLC
Investigator: Klein, Nicola

A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants


Funder: ICON Clinical Research PLC
Investigator: Klein, Nicola

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 ...
Funder: GlaxoSmithKline PLC
Investigator: Klein, Nicola

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...
Funder: Patient-Centered Outcomes Research Institute
Investigator: Silverberg, Michael

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, includi...
Funder: Gilead Sciences, Inc.
Investigator: Silverberg, Michael

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...
Funder: Patient-Centered Outcomes Research Institute
Investigator: Silverberg, Michael

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 ...
Funder: National Institute of Allergy and Infectious Diseases
Investigator: Zerbo, Ousseny

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 col...
Funder: Pfizer Inc.
Investigator: Klein, Nicola

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 Oct...
Funder: Patient-Centered Outcomes Research Institute
Investigator: Silverberg, Michael

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 infl...
Funder: Centers for Disease Control and Prevention
Investigator: Klein, Nicola

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 ...
Funder: Pfizer Inc.
Investigator: Klein, Nicola

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...
Funder: National Institute on Alcohol Abuse and Alcoholism
Investigator: Satre, Derek; Silverberg, Michael

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 i...
Funder: Pfizer Inc.
Investigator: Klein, Nicola
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