Vaccine Safety and Effectiveness studies

Our research team brings its vast expertise to conduct studies to determine the safety and effectiveness of vaccine use in clinical practice and to monitor health problems after vaccination. Studies range from the incidence and outcomes of vaccine-preventable diseases to widely used vaccines such as herpes zoster and the human papillomavirus and flu vaccines. Also see our brochure on the Center for Vaccine Safety and Effectiveness Research.

Boostrix immunization in pregnant women

The goal of the Boostrix study is to examine pre-specified pregnancy-related adverse events in a cohort of women vaccinated with Boostrix at 27 weeks gestation or beyond compared to a matched historical unvaccinated control group.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

GlaxoSmithKline, LLC

Funding Years:

2017 - 2021

Comparison of vaccine effectiveness against hospitalization for influenza between cell-based and egg-based influenza vaccines

The proposed study aims to compare the vaccine effectiveness (VE) against hospitalization for influenza between Flucelvax Quadrivalent and egg-based influenza vaccines used in Kaiser Permanente Southern California (KPSC) during the 2017-2018 season.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Seqirus, Inc.

Funding Years:

2018 - 2019

Development and application of a smartphone-based data collection method for adverse events following SARS-CoV-2 vaccination in the Vaccine Safety Datalink

The proposed project will involve designing, piloting, evaluating, and expanding an SMS- and web-based Vaccine Safety Monitoring (VSM) system.

Principal Investigator:

Sara Yee Tartof, PhD, MPH

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2021 - 2024

Effectiveness of pneumococcal conjugate vaccine against severe clinical outcomes of coronavirus disease 2019 (COVID-19) among adults: a cohort study

The objectives of this study were to assess the effectiveness of PCV13 against severe COVID-19 outcomes and to assess the burden of PCV13-preventable illness attributable to COVID-19.

Principal Investigator:

Sara Yee Tartof, PhD, MPH

Funding Source:

Pfizer, Inc.

Funding Years:

2020 - 2021

Effectiveness of pneumococcal vaccination to prevent hospitalized all-cause pneumonia among adults =18 years at Kaiser Permanente Southern California

The objectives of this study are to estimate the incidence of invasive pneumococcal disease (IPD), pneumococcal pneumonia (PP), all-cause pneumonia, and lower respiratory tract infections (LRTI) by Advisory Committee on Immunization Practices (ACIP)-defined risk profile in adults =18 years.

Principal Investigator:

Sara Yee Tartof, PhD, MPH

Funding Source:

Pfizer, Inc.

Funding Years:

2020 - 2021

EPI-ZOSTER-031 Long-term vaccine effectiveness study of Shingrix in US adults 50 years and older

The objective is to conduct a long-term study at KPSC to assess vaccine effectiveness among individuals receiving recombinant zoster vaccine (RZV) compared to individuals not receiving RZV.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

GlaxoSmithKline, LLC

Funding Years:

2018 - 2034

EPI-ZOSTER-044 Concept Protocol: Effectiveness and safety of recombinant zoster vaccine in patients with rheumatoid arthritis (RA) or inflammatory bowel disease (IBD)

The objectives of this study are to evaluate the real-world effectiveness and safety of recombinant zoster vaccine (RZV) in patients with rheumatoid arthritis (RA) and patients with inflammatory bowel disease (IBD), including ulcerative colitis (UC) or Crohn’s disease (CD).

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

GlaxoSmithKline, LLC

Funding Years:

2020 - 2021

EPI-ZOSTER-089 Effect of RZV on reducing the risk of hospitalization due to COVID-19

The Recombinant Adjuvanted Zoster Vaccine (RZV, Shingrix®) was approved in 2017 by the FDA for the prevention of herpes zoster (HZ) in adults ages 50 years and older. With a potent adjuvant system, it is hypothesized that RZV could induce trained innate immunity. As the first approved and widely used vaccine with the novel AS01 adjuvant system, we are investigating the potential non-specific effect of RZV against COVID-19.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

GlaxoSmithKline, LLC

Funding Years:

2021

Extended Herpes Zoster Vaccine Effectiveness in a Health Maintenance Organization

The objectives of this study are to conduct a retrospective cohort study to evaluate the long-term effectiveness of the zoster vaccine for preventing HZ and PHN among persons 60 years of age or older. Understanding the long-term duration of vaccine effectiveness will be critical for monitoring impact of the zoster vaccination program, as well as for informing policy decisions that the ACIP will face, such as the consideration of a booster dose, and determining the optimum age to begin vaccination.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2014 - 2020

Feasibility Assessment prior to conducting a BNT162b2 Vaccine Effectiveness case-control study at Kaiser Permanente South California

The objectives of this large retrospective data-only study are to use two parallel study designs to assess the VE of Pfizer COVID-19 vaccine against 2 primary endpoints: 1.) Severe outcomes (COVID-19 associated hospitalization, ICU admission, and death); and 2.) Outpatient laboratory-confirmed COVID-19 diagnosis.

Principal Investigator:

Sara Yee Tartof, PhD, MPH

Funding Source:

Pfizer, Inc.

Funding Years:

2020 - 2021

HEPLISAV-B Post Marketing Surveillance Study

The primary objective of this post-marketing observational surveillance study is to compare the occurrence of acute myocardial infarction (AMI) in recipients of HEPLISAV-B with recipients of another hepatitis B vaccine. The study will also evaluate the incidence of new onset immune-mediated diseases, herpes zoster, and anaphylaxis in recipients of HEPLISAV-B compared to recipients of another hepatitis B vaccine.

Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

Dynavax Technologies

Funding Years:

2017 - 2021

Impact of the introduction of the Recombinant Zoster Vaccine (RZV) on clinical outcomes and payer budgets over a short-to-intermediate horizon- HO-17-18378

To better understand the short-term impact of the introduction of RZV on clinical outcomes and payer budgets, GSK has developed a US-specific budget impact model that is utilized as a flexible tool for different types of US population-based decision makers. The model can be customized to reflect the patient population information and outcomes associated with RZV vaccination scenarios. We will describe the demographics, epidemiology, and health care utilization associated with herpes zoster in the KPSC population. This information will contribute to the inputs for the budget impact model.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

GlaxoSmithKline, LLC

Funding Years:

2018 - 2019

Impact of Tier 6 in Medicare Part D on Zoster Vaccination Uptake

The objective of this study is to assess the impact of the introduction of Tier 6 in Medicare Part D on zoster vaccination rates among persons who are 65 years or older with Medicare Part D coverage, accounting for secular factors such as vaccine supply, DTC advertising, increasing awareness of the zoster vaccine, and general promotion of vaccination among the elderly.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

GlaxoSmithKline, LLC

Funding Years:

2013 - 2015

Kaiser Permanente Southern California and Novavax Collaboration on RSV Epidemiology

The purpose of this study is to provide critical information about the predictors of severe RSV disease, describe epidemiology and burden of hospitalized RSV disease in older adults, and assess healthcare utilization associated with hospitalized RSV disease in older adults in a community setting. A population of hospitalized older adults testing positive for influenza will also be identified for comparison purposes.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Novavax, Inc.

Funding Years:

2016 - 2018

Long Term Herpes Zoster Vaccine Effectiveness in a Health Maintenance Organization

The objectives of this study are to conduct a retrospective cohort study to evaluate the long-term effectiveness of the zoster vaccine for preventing HZ and PHN among persons 60 years of age or older. Understanding the long-term duration of vaccine effectiveness will be critical for monitoring impact of the zoster vaccination program, as well as for informing policy decisions that the ACIP will face, such as the consideration of a booster dose, and determining the optimum age to begin vaccination.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2013 - 2016

Measuring Effectiveness of Two Doses of Varicella Vaccine in Los Angeles County

The primary objective of this study is to calculate the incremental effectiveness of the 2-dose varicella vaccination regimen in preventing breakthrough disease compared to the 1-dose regimen among children aged 5 to 14 years in Antelope Valley, California.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2010 - 2011

Menveo Post-Licensure Safety Study in Individuals 2-10 and 11-21 Years of Age

This study will fulfill a post-marketing commitment between Novartis Vaccines and Diagnostics and the FDA to expand the safety profile of this vaccine in this age group. This is an observational study and is expected to span multiple years within KPSC. Subjects will be immunized with Menveo as part of their routine care. Subjects who have been vaccinated with Menveo and have experienced an event of interest during the first year are selected for analysis; and subjects are selected for analysis using the SCCS methodology, which sums the occurrence of events that fall within a risk window and those that do not fall within these windows.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Novartis Pharmaceuticals Corporation

Funding Years:

2011 - 2018

Menveo Pregnancy Registry Study

The objective of the Menveo Pregnancy Registry is to evaluate pregnancy outcomes among women immunized with the Menveo vaccine within 28 days prior to conception or at any time during pregnancy. The primary outcomes of interest include major congenital malformation, preterm birth, and low birth weight. Other pregnancy outcomes will be collected, including spontaneous abortions and stillbirths.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

GlaxoSmithKline, LLC

Funding Years:

2015 - 2018

Pfizer COVID-19 BNT162b2 Vaccine Effectiveness Study

Collect positive SARS-CoV-2 specimens and conduct sequencing to identify variant types.

Principal Investigator:

Sara Yee Tartof, PhD, MPH

Funding Source:

Pfizer, Inc.

Funding Years:

2021 - 2024

Post-licensure observational safety surveillance study of quadrivalent meningococcal ACWY conjugate vaccine in children 2-23 months of age

This study is an observational post-marketing safety study required by the United States Food and Drug Administration (FDA). The primary objective of this study is to describe medical events that require emergency room visit or hospitalization in 6 months following MenACWY-CRM vaccination in children 2-23 months of age in a health maintenance organization (HMO) in the United States.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Novartis Vaccines and Diagnostics, Inc.

Funding Years:

2014 - 2018

Real-World Study of Effectiveness of Moderna COVID-19 Vaccine under Emergency Use Authorization and Subsequent Licensure

An observational cohort study to evaluate vaccine effectiveness of Moderna COVID-19 vaccine in preventing COVID-19 diagnosis and severe COVID-19 disease.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

ModernaTX, Inc.

Funding Years:

2020 - 2026

Understanding and supporting COVID-19 vaccine confidence among health care providers

The purpose of this mixed-methods study is to examine perceptions of COVID-19 vaccines among health care providers, willingness to receive and recommend COVID-19 vaccine, drivers of vaccine hesitancy, and needs for tailored interventions to support confidence in COVID-19 vaccines among health care providers and community members.

Principal Investigator:

Katia Bruxvoort, PhD, MPH

Funding Source:

Kaiser Permanente

Funding Years:

2021

Vaccine Safety Datalink (VSD) COVID-19 Vaccine Infrastructure and Participating Site Activities

The purpose of this task order is for the contractors to contribute to the main functions of VSD COVID-19 vaccine safety activities. The work from this task order will support and contribute to the COVID-19 vaccine safety work of the VSD. The objective is to provide high quality electronic data specific to COVID-19 vaccine safety activities. Contractors will also contribute to vaccine safety assessments through their participation on vaccine safety monitoring and evaluation studies, and by conducting medical record reviews.

Site Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2021 - 2024

Vaccine Safety Datalink Project-CDC

VSD is a multi-site study of vaccine safety in a network of managed care organizations from across the US. The VSD project allows for planned immunization safety studies as well as timely investigations of hypotheses that arise from review of medical literature, reports to the Vaccine Adverse Event Reporting System (VAERS), changes in immunization schedules, or the introduction of new vaccines.

Site Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2017 - 2022

Zoster Vaccine and Risk Factors of Zoster and Post-Herpetic Neuralgia

The aims of the study are to determine the incidence of reactivation of Oka strain VZV in community-dwelling persons vaccinated with zoster vaccines; to test clinical isolates for evidence of recombination between vaccine and wild-type strains VZV; to identify risk factors of HZ among individuals vaccinated with zoster vaccines; to identify risk factors for post-herpetic neuralgia (PHN) among HZ cases who were either vaccinated or unvaccinated with zoster vaccines, and to compare the clinical manifestations and risk of PHN between vaccinated and unvaccinated individuals.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

National Institute of Allergy and Infectious Diseases (NIAID)

Funding Years:

2011 - 2017