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Infectious Diseases Studies

 

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

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
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