UC Davis Health was one of about 120 trial sites selected worldwide to participate in the Phase 2/3 stage testing of the COVID-19 vaccine candidate known as BTN162, developed by Germany’s BioNTech and Pfizer Inc. The addition of this pivotal clinical trial adds even a more significant component to the university’s response to COVID-19. Now Davis, California—near Sacramento—is hosting the major clinical trial and 200 volunteers are needed. UC Davis’ Medical Center providers diagnosed and treated the first apparent case of COVID-19 in the United States, according to their recent news release. UC Davis Health represents the hub of medical research for Sacramento, California’s capital and rapidly growing metropolis.
UC Davis Health, according to David Lubarsky, vice chancellor of human health sciences and chief executive officer for UC Davis Health is “uniquely positioned to help with a possible breakthrough,” contributing to this pivotal study because 1) deep clinical trials expertise, 2) ability to expedite the recruitment of study volunteers, and 3) track record of engaging with minority communities that can translate to more diverse volunteers.
The research trial, known as a phase 2/3 study, seeks to determine the efficacy and side effects of a single nucleoside-modified messenger RNA (modRNA) candidate from their BNT162 mRNA-based vaccine program. The vaccine candidate has undergone rigorous evaluation in the United States and Germany and has previously shown significant positive results.
The phase 2/3 trial is designed as a 1:1 investigational vaccine candidate for placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review.
The study represents “A historic opportunity for the UC Davis School of Medicine and the community at large,” quoted Allison Brashear, dean of the UC Davis School of Medicine. Dean Brashear confidently pointed out, “Our academic medical center is well equipped and staffed to take on this critical role and we are eager to take an active role in helping develop a vaccine.”
This vaccine study seeks high risk volunteers, that is those that face a higher probability of COVID-19 infection, from health care employees and those working in businesses with high volumes of customers to essential workers who spend considerable time outside the home. Certain ethnic groups have been hit harder by COVID-19, such as Blacks and Latinos. UC Davis should contribute to recruiting higher proportions of these demographic groups based on risk severity profiles. First responders could also fit in this category. Candidates must be healthy and between the ages of 18 and 85.
Diversity in the Sacramento Region
TrialSite has profiled small commercial research sites in the Sacramento metropolitan area. In “Will Clinical Research Grow In California’s Capital,” UC Davis Health is considered the research hub in a thriving, incredibly diverse metropolis of 2.2 million people, just an hour from the 7 million inhabitants of the San Francisco Bay Area and Silicon Valley. The region continues to grow as housing is more affordable than the astronomical prices of the adjacent Bay Area, while access to the spectacular Sierra Nevada mountain range to just over an hour’s drive to the coast, Wine Country and all that Northern California has to offer, the City of Sacramento itself may just be one of the most integrated places in the United States.
Hence, UC Davis Health provides healthcare needs to multiple races and ethnicities, which the university posits in its recent press release, “increases the chances of identifying clinical trial candidates from more diverse backgrounds than other communities in the United States.” The academic medical center’s article reminds all readers that Blacks and Latinos have been hit particularly hard by the pandemic, with infections significantly higher than other demographic groups.
Collaborative Academic Medical Center
UC Davis’ current efforts involve an intensive collaboration between pulmonologists and infectious diseases specialists in the medical center’s intensive care units, clinical laboratory pathologists, virologists from medical microbiology, the California National Primate Research Center and the Center for Immunology and Infectious Diseases. The university seeks to better understand the biology and infectious pathology of this new virus and collaborate on new treatment and diagnostic approaches.
The pharmaceutical giant Pfizer, which has teamed up with the smaller BioNTech of Germany, selected vaccine study sites known for their world-class research experience, infrastructure, and nearby concentrations of known and anticipated positive COVID-19 cases.
Principal Investigator Point of View
Timothy Alberton, chair of the UC Davis Health internal medicine department and leading expert in pulmonary and critical care medicine, serves the study as principal investigator while Angela Haczku, associate dean for translational research will support as co-principal investigator.
Dr. Alberton commented, “UC Davis and our research group are pleased to be part of this global trial, which is a testament to our long history of working with our pharmaceutical partners to improve the lives of not only our patients, but people around the world.” While Dr. Haczku sought to position the investigational vaccine by suggesting: “Although there are a number of COVID-19 vaccine candidates worldwide, this one differs because it utilizes a novel modified mRNA (messenger ribonucleic acid), which includes a piece of the genetic code of SARS-CoV-2, the virus that causes COVID-19,” Haczku said. “We are very excited, as this is the first time in history that mRNA-based vaccines are used against an infectious disease. Based on the promising results of preliminary trials, we expect to see protection of vaccinated individuals against COVID-19.
Timothy Albertson, MD, MPH, PhD, chair of the UC Davis Health internal medicine department and leading expert in pulmonary and critical care medicine
Angela Haczku, MD, PhD, associate dean for translational research
Call to Action: If you live in the Sacramento area, consider participation in this study. Also UC Davis Health shows up in a lot of “Bests” with the recent US News & World Report provider rankings.