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Infectious Diseases Studies

 

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...
Funder: National Institute of Allergy and Infectious Diseases
Investigator: Lam, Jennifer

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 impleme...
Funder: Centers for Disease Control and Prevention
Investigator: Skarbinski, Jacek

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 co...
Funder: Centers for Disease Control and Prevention
Investigator: Skarbinski, Jacek

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.
Funder: Centers for Disease Control and Prevention
Investigator: Zerbo, Ousseny

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.
Funder: Pfizer Inc.
Investigator: Klein, Nicola

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.
Funder: Pfizer Inc.
Investigator: Klein, Nicola

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...
Funder: Merck & Company, Inc.
Investigator: Klein, Nicola

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 ...
Funder: Merck & Company, Inc.
Investigator: Klein, Nicola

(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 ...
Funder: National Cancer Institute
Investigator: Silverberg, Michael

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 o...
Funder: Merck & Company, Inc.
Investigator: Klein, Nicola

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.
Funder: Pfizer Inc.
Investigator: Klein, Nicola

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

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 v...
Funder: Sanofi Pasteur S.A.
Investigator: Klein, Nicola

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

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

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.
Funder: Gilead Sciences, Inc.
Investigator: Skarbinski, Jacek

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.
Funder: National Cancer Institute
Investigator: Skarbinski, Jacek

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
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