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Infectious Diseases Studies

 

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

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

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 an...
Funder: Centers for Disease Control and Prevention
Investigator: Silverberg, Michael

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.
Funder: GlaxoSmithKline PLC
Investigator: Klein, Nicola

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

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

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

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

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

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 includ...
Funder: National Institute on Aging
Investigator: Silverberg, Michael

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 ...
Funder: The Rockefeller Foundation
Investigator: Skarbinski, Jacek

Tuberculosis Epidemiologic Studies Consortium III

The goals of this study are to identify primary care settings that serve non-U.S.born persons at risk for latent tuberculosis infection and tuberculosis disease; collect retrospective and prospective electronic medical record data; design and implement cl...
Funder: Centers for Disease Control and Prevention
Investigator: Skarbinski, Jacek

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
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