In the effort to save lives and find another safe and effective COVID-19 vaccine, Stony Brook Medicine is participating in a Phase 3 clinical trial to test the safety and effectiveness of a Novavax investigational vaccine for SARS-CoV-2, the novel coronavirus that causes COVID-19.
Stony Brook is the only Long Island site participating in this clinical trial, and one of two in New York State to be selected for the trial.
The study began on Dec. 27 and is led locally by principal investigator Benjamin J. Luft, MD, Edmund D. Pellegrino Professor of Medicine at the Renaissance School of Medicine at Stony Brook University, and Adult Infectious Diseases Expert; and Sub-Investigator Sharon Nachman, MD, Professor of Pediatrics and Associate Dean for Research at the Renaissance School of Medicine. The randomized, blinded placebo-controlled phase III clinical trial will assess the immunity and safety of the Novavax vaccine candidate, as well as its ability to reduce disease in those who contract the virus.
Sponsored by the National Institutes of Health’s (NIH) COVID-19 Prevention Network, the study will recruit up to 30,000 participants at multiple sites across the U.S. and Mexico. Stony Brook is expected to enroll 500 participants, with the vaccine distributed mainly through Stony Brook Medicine’s Advanced Specialty Care in Commack, because of its ease of access and on-site phlebotomy and pharmacy.
Stony Brook was chosen as a trial center, in part, because of the institution’s outstanding expertise in infectious disease research – including vaccinology – and for the ability to perform clinical trials in subjects with complex medical conditions. The study will leverage Stony Brook’s extensive relationships with the first responder and essential worker communities to offer the vaccine trial to those at particularly high risk. Additionally, Stony Brook aims to bring the vaccine trial to underrepresented populations who are also at higher risk for infection.
The clinical trial is a pivotal phase-three study, following phase one and two trials, in which volunteers produced strikingly high levels of antibodies. The results from the phase one study were published in the September issue of The New England Journal of Medicine. There are many benefits to participating in the study:
- Level of antibody production. Based on Novavax’s phase two study, patients who received the investigational vaccine have reached protective levels of antibody production lasting for as long as they have been followed in the clinical trial.
- Two-to-one randomization. The clinical trial is a two-to-one randomization of an investigational vaccine compared to placebo (most vaccine studies are one to one). This means that for every two people who receive the vaccine candidate, one will receive a placebo — increasing a participant’s chances of receiving the vaccine candidate.
- Follow-up and monitoring. Each participant will be monitored for a two-year period. This will allow for a long-term safety assessment of all participants in the clinical trial.
Participants must be enrolled over a six- to eight-week period. They must be over age 18 and have not previously tested positive for COVID-19. At least twenty-five percent of participants must be 65 years of age or older. Those who are more likely to have an increased risk of SARS-CoV-2 infection due to community exposure, such as working in jobs that requires public interaction, are encouraged to participate.
Participants must be in reasonably good health, including those who have preexisting conditions, such as high blood pressure, diabetes or heart disease, that are stable. The investigational vaccine is not live, so participants cannot become ill with COVID-19 as a result of receiving the vaccine candidate. Enrollees are encouraged to have gotten their flu vaccine prior to enrolling in the study. All vaccines, including the flu vaccine, must be received at least four days prior to, or seven days after, receiving any study-related injections.
For more details about the clinical trial and Novavax, see this link.