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
At the Kaiser Permanente Vaccine Study Center
Research Team
Our team includes the director, who serves as principal investigator with primary responsibility for our studies; a postdoctoral research fellow; 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.
Computing Capacity
Our computing capacity includes an array of dedicated servers.
In the Field
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.
Pre-licensure Field Studies
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 principle 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 Field Studies
The final phase of vaccine testing, Phase 4, occurs after a vaccine has been licensed and brought to market. This culminating study is of vital importance, because it tests the safety of the new vaccine in real-world use, after it has been administered to many more patients than those included in earlier research. 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.
Process
We typically prepare for a Phase 4 study by coordinating 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.
Partnerships
Kaiser Permanente Division of Research
We share staff, technology and other key resources with the Division of Research (DOR), our primary collaborator in all aspects of our work. Our close link enables us to draw upon the programming, statistical and epidemiological expertise available at the DOR and related organizations throughout Kaiser Permanente.
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.
Government
We work closely 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. The programs in which we participate include the following:
Communicating Research Findings
Kaiser Permanente Vaccine Study Center researchers disseminate their findings through publications, presentations at conferences, and lectures throughout the nation.
