We help protect public health with the following programs:
Pre-licensure Clinical Trials
We conduct studies for manufacturers that are developing new vaccines that are not yet licensed. Our role is to examine how the vaccines work and how effective they are. Study participants are drawn from our large population of Kaiser Permanente members. We carry out randomized, controlled clinical trials at many different Kaiser Permanente medical facilities, under the direction of full-time clinical research registered nurses, with oversight from physicians at each facility. The information from these trials goes to the Food and Drug Administration (FDA), which decides whether or not to license the vaccine.
Vaccines undergo three phases of testing for safety and efficacy before they can be licensed and brought to market. The Kaiser Permanente Vaccine Study Center conducts Phase 2 and Phase 3 studies of vaccines for manufacturers. Our phase 2 studies typically enroll 300 to 700 participants. Phase 3 studies typically enroll between 2,000 and 3,000 of our members. We conduct these studies in clinics at our largest Northern California medical centers. Each study is carried out by a full-time clinical research registered nurse, with supervisory oversight from a physician at the medical facility where the study is being conducted. The principal investigator at the Kaiser Permanente Vaccine Study Center has ultimate supervisory responsibility for each study.
Enrollment and Follow-Up
Patients who are eligible for a study are invited by their personal physician to speak with the study nurse, who presents the study in detail and explains the time commitment involved, the risks and the potential benefits. Those who choose to enroll in the study give their consent to participate through a formal process that follows a protocol approved by Kaiser Permanente’s Northern California Institutional Review Board. Study participants receive study materials, and are followed throughout the study, including a follow-up exit call six months after their last vaccine dose.
Post-licensure Surveillance Studies
Once the vaccine is licensed and marketed, the FDA requires the manufacturer to conduct another study with larger numbers of participants to test the vaccine’s safety in real-world use. We monitor the records of vaccine recipients, using a variety of studies that we design and carry out, to make sure the vaccine is safe.
Typically, our Phase 4 studies involve monitoring the records of anywhere from 10,000 to 190,000 patients, depending on the vaccine being tested, to detect and analyze any adverse events, such as illness, associated with immunizations. We coordinate with the manufacturer to develop a protocol well before a vaccine comes into use.
Once the vaccine is licensed, we submit the study protocol to Kaiser Permanente’s Northern California Institutional Review Board for approval. We then scan our vast databases to gather information about members who have received the vaccine. (This information is not identified with individual patients.) Our aim is to learn about events, such as Emergency Department visits or hospitalizations, which might possibly be associated with the immunizations. We monitor and use statistical techniques to compare data from the same patient population six weeks after immunization and, again, three months after immunization.
Other types of studies
Epidemiological Studies
We collaborate with other researchers, industry, and government to study the impact of a disease on the public and to assess whether or not the impact is sufficiently serious and widespread to warrant developing a new vaccine to prevent the disease.
Surveillance of Influenza and other Respiratory Viruses
Respiratory viruses, including influenza and respiratory syncytial virus (RSV), have a significant impact on public health, and bring outbreaks of respiratory disease every winter. For many years, the Kaiser Permanente Vaccine Study Center has tracked these viruses and their impact on our members. We send memos to all our physicians giving them the most current information about how to test and treat patients. We know before anyone else in the state when the flu season begins.
Studies of Vaccine Effectiveness
Our studies seek to determine how well vaccines prevent the illness they are designed to prevent. We have developed new, more precise epidemiological methods for assessing the effectiveness of the flu vaccine. Our new methods address certain biases in data that have affected such studies in the past. We are grateful to Kaiser Permanente’s Community Benefit Program for supporting this work.
Studies of Vaccine Safety in Special Populations
We conduct studies specifically evaluating the safety of vaccines administered to children in special populations. These can include infants and children such as babies born prematurely or children with genetic or chronic medical conditions. These children are vulnerable to becoming very sick from vaccine-preventable diseases, but there have been limited numbers of studies investigating the safety of vaccinating this fragile population.
Genetics of Vaccine Responses and Adverse Events Following Immunization
We are very interested in studies evaluating genomic influences on both vaccine responses and vaccine adverse events.
How We Work
Resources
As part of Kaiser Permanente, the nation’s largest nonprofit health plan, we have the unique opportunity to conduct trials and research drawing upon the following:
- research participants from Kaiser Permanente’s large, diverse member base
- the largest civilian electronic medical record system in the world
- a patient database that is one of the largest and most comprehensive in the world
- Kaiser Permanente’s integrated, comprehensive health care system, which enables us to track all aspects of the care provided to research participants
Research Capacity
Our research team includes the director, who serves as principal investigator with primary responsibility for our studies; a research scientist; an administrative director; research and project managers; programmers who specialize in vaccine safety; statisticians; medical records analysts who review the accuracy of patients’ charts; research associates.
Our computing capacity includes an array of dedicated servers.
We conduct studies of vaccine efficacy and safety at Kaiser Permanente medical centers throughout Northern California. All study personnel are certified as investigators by Kaiser Permanente’s Northern California Institutional Review Board.
Partnerships
We share staff, technology and other key resources with our primary collaborator, the Kaiser Permanente Division of Research (DOR). We draw upon the programming, statistical and epidemiological expertise available at the DOR and related organizations throughout Kaiser Permanente.
In collaboration with industry, we conduct pre-licensure clinical studies of vaccine safety and efficacy for all major vaccine producers in the United States, and we monitor the safety of vaccines that have been licensed. Manufacturers for whom we conduct clinical trials to test the safety and efficacy of vaccines before they can be licensed and post-licensure safety surveillance include: GSK, MedImmune, Merck, Novartis, Pfizer, Protein Sciences and Sanofi-Pasteur.
We also work closely with the federal government, through partnerships with the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA), conducting research on vaccine safety and efficacy both before and after vaccines are licensed for use in the United States.
Our work for the CDC involves vaccine surveillance and retrospective research examining vaccine safety.
We collaborate with CDC’s Immunization Safety Office (ISO), which includes the following:
- Vaccine Safety Datalink (VSD) Project
- Clinical Immunization Safety Assessment (CISA) Network
- Vaccine Adverse Event Reporting System (VAERS) – See Food and Drug Administration, below
The Kaiser Permanente Vaccine Study Center is the only organization in the country that participates in both the CISA Network and the VSD Project.
VSD Project
In partnership with the CDC and other large health care organizations, we conduct studies of vaccine safety using large linked databases. This approach enables us to study large numbers of people who have received a vaccine to determine whether they have had any adverse outcomes. Studying large populations is particularly important for detecting the possibility of a relationship between vaccines and adverse events, such as illnesses, especially if the adverse event is rare.
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CISA Network
In partnership with the CDC and six academic medical research centers throughout the United States, we examine the physiological mechanisms of adverse reactions to vaccines and the risk factors associated with having an adverse event following immunization (AEFI). CISA also counsels clinicians about vaccine safety and is developing evidence-based evaluation guidelines for clinicians.
Learn more
VAERS
We participate with other research organizations in the Vaccine Adverse Event Reporting System (VAERS), a national vaccine safety surveillance program co-sponsored by the CDC and the FDA. As part of VAERS, we help gather, analyze and disseminate information about possible adverse outcomes that occur after vaccines licensed for use in the United States have been administered. VAERS also disseminates information about vaccine safety.
