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

EPI-ZOSTER-031 VE, Long-term effectiveness study of Shingrix in US adults>=50 years

The objective is to examine the feasibility of conducting 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

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 - 2024

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.

Principal Investigator:

Steven J. Jacobsen, MD, PhD

Funding Source:

Dynavax Technologies

Funding Years:

2017 - 2020

Impact of the introduction of the HZ/su Vaccine on clinical outcomes and payer budgets over a short-to-intermediate horizon- HO-17-18378

The objective of the study is to understand the impact of the introduction of recombinant zoster vaccine (RZV) for herpes zoster (HZ) over a short-to-intermediate time frame in collaboration with GlaxoSmithKline (GSK).

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

GlaxoSmithKline, LLC

Funding Years:

2018 - 2019

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:

Prevention and Public Health Fund (PPHF)

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

These studies are initiated to fulfill this post-marketing commitment between Novartis Vaccines and Diagnostics and the FDA to expand the safety profile of this vaccine in this age group. These are observational studies and are 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 ages 11-21 years of age 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

Occurrence of Herpes Zoster Among Elderly Population 60 or More Years of Age: A Comparison Between Vaccinated and Unvaccinated Population

The specific aims of the study are to evaluate the incidence of HZ among elderly population 60 or more years of age who were either vaccinated or not vaccinated with the vaccine and to evaluate whether some potential chronic conditions would modify the effect of the vaccine. The additional aims are to compare the healthcare utilization between vaccinated HZ cases and unvaccinated HZ cases, to compare the incidence of stroke in one year after HZ episode between vaccinated HZ cases and unvaccinated HZ cases, and to compare the incidence of HZ between concomitant and sequential administration of PPV 23 and Zostavax.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2012

Post-licensure observational safety surveillance study of quadrivalent meningococcal ACWY conjugate vaccine

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

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.

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