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Infectious Diseases Studies

 

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 Kaise...
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...
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 influ...
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...
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 ...
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 pro...
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

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

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

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

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

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) T...
Funder: Office of the Assistant Secretary for Health
Investigator: Klein, Nicola

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 ...
Funder: The Permanente Medical Group
Investigator: Silverberg, Michael

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.
Funder: 
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 o...
Funder: National Heart, Lung, and Blood Institute
Investigator: Silverberg, Michael

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.
Funder: Pfizer Inc.
Investigator: Klein, Nicola
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