Ranked as the 18th largest healthcare system in the United States, Kaiser Permanente isn’t afraid of ambitious targets as its’ California-based research organizations are no exception, raising the bar by planning to enroll up to 5% of all study participants in the worldwide Phase 3 Pfizer and BioNTech BNT162b2 clinical trial. Kaiser Permanente commenced participation in the “Project Lightspeed” initiative, which is the partnership between Germany’s BioNTech and Pfizer Inc. to develop and commercialize one of the leading COVID-19 vaccine candidates known as BNT162b2, part of the mRNA-based BNT162 vaccine program. Launching the pivotal Phase 3 clinical trial, Kaiser Permanente plans on enrolling approximately 1,400 participants at four sites in California and Oregon, representing a substantial 5% of the total global volunteer pool. This enrollment effort contributes to a total of 30,000 participants that will ultimately be enrolled from 120 sites, required for the pivotal Phase 3 study. Participating sites include Kaiser Permanente Center for Health Research in Portland, Oregon, as well as the Department of Research & Evaluation in Pasadena, California, and the Division of Research in Oakland, California.
The Study Participants
Kaiser Permanente clinical trial participants must be adult health plan members aged 18 to 85 years old who are not pregnant or planning to become pregnant during the trial.
The phase 3 trial is a randomized trial in which half of the participants will receive the vaccine, and half will receive a placebo. Neither the participants nor the clinicians will know who is receiving the vaccine versus the placebo (known as a double-blind study). During this phase of the trial, data will be gathered about safety, immune response, and efficacy as required for regulatory review.
Principal Investigator POV
Nicola Klein, MD, PhD, director of the Kaiser Permanente Vaccine Study Center and Principal Investigator for the clinical trial out of Northern California (Oakland) reports, “Kaiser Permanente is extremely well-positioned to address this public health emergency.” Dr. Klein emphasized this prominent health system’s experience “We have been a leader in vaccine research for more than 30 years and have participated in clinical trials for almost every vaccine that has been licensed in the United States. We know we can meaningfully contribute to helping determine whether this vaccine is effective in preventing COVID-19 disease.”
While Stephen Fortmann, MD working out of Portland, OR at Kaiser Permanente Center for Health Research commented, “Our researchers and physicians are eager to contribute to the independent science that will ultimately lead the development of a vaccine for COVID-19.” Dr. Fortmann continued. We are working with researchers globally to ensure timely, safe, and effective vaccines can be developed so that we can prevent illness and save lives.
“This virus is a tremendous health threat and has affected the world profoundly both economically and socially,” said William J. Towner, MD, regional physician director, Division of Clinical Trials Research, and principal investigator for the trial at Kaiser Permanente’s Department of Research & Evaluation. “It is imperative that we find a safe and effective vaccine as quickly as possible.”
Kaiser Permanente is working on two of the most prominent COVID-19 vaccine trials in the United States, playing an integral role in the development of another COVID-19 investigational vaccine, co-developed by the National Institute of Allergy and Infectious Diseases and Moderna, Inc. The Kaiser Permanente Washington Health Research Institute in Seattle was the first site to enroll participants in the phase 1 trial. The vaccine began phase 3 trials at the end of July.
About Kaiser Permanente
The Kaiser Permanente Division of Research conducts, publishes and disseminates epidemiologic and health services research to improve the health and medical care of Kaiser Permanente members and society at large. It seeks to understand the determinants of illness and well-being and improve the quality and cost-effectiveness of health care. Currently, DOR’s 600-plus staff is working on more than 450 epidemiological and health services research projects. For more information, visit divisionofresearch.kaiserpermanente.org or follow us @KPDOR.