Stony Brook selected to participate in a COVID-19 Prevention Network study that aims to test the safety and effectiveness of a COVID-19 vaccine candidate
Stony Brook Medicine is the only site on Long Island and one of two in New York State to be selected to participate in the Novavax Phase Three clinical trial to assess the safety and effectiveness of an investigational vaccine designed to protect against SARS-CoV-2, the novel coronavirus that causes COVID-19. The clinical trial, to enroll participants over the course of six to eight weeks, will measure whether the vaccine candidate can protect against COVID-19 infection, as well as its ability to reduce the severity of the disease.
A need for several effective vaccines to curb the pandemic
Sponsored by the National Institutes of Health’s (NIH) COVID-19 Prevention Network (CoVPN), the Novavax clinical trial will recruit up to 30,000 participants at approximately 110 sites across the U.S. The trial arm at Stony Brook Medicine will involve an estimated 500 participants.
“In order to bring rapid public vaccination programs to both the U.S. and other countries of the world, we need several effective COVID-19 vaccines,” said principal investigator Benjamin Luft, MD, Edmund D. Pellegrino Professor of Medicine at the Renaissance School of Medicine at Stony Brook University. “We all want to see economies reopen, schools resume in person, travel restrictions lifted and the ability to gather with the people who matter to us.”
Stony Brook Medicine was chosen as a trial center, in part, because of its expertise in infectious disease research — including vaccinology — and for its ability to perform clinical trials in people with complex medical conditions. Stony Brook was also selected for its strong relationships with the first responder and essential worker community, and for its ability to bring vaccine trial opportunities to underrepresented populations who are at higher risk for infection.
“Our researchers are an important part of the national scientific response to finding an ‘exit strategy’ to curb this terrible pandemic — by contributing on a local and global scale with research grounded in early detection, monitoring, efficacy of new and existing treatments, and, ultimately, effective vaccines to prevent future outbreaks,” said Kenneth Kaushansky, MD, MACP, Senior Vice President, Health Sciences and Dean, Renaissance School of Medicine at Stony Brook University.
Importance of inclusivity in trial enrollment
According to the Centers for Disease Control and Prevention (CDC), the rate of COVID-19 Black and Latin cases are three times that of white cases, and in New York State, people who are Black are twice as likely to die from the disease than those who are white. Native Americans are also particularly vulnerable to developing severe health problems as a result of COVID-19, as are older adults of all populations.
“In our area, like other areas across the country, the coronavirus has disproportionately affected people who live in underserved communities and those who are over the age of 65,” said Dr. Luft. “For a vaccine to be effective for all, it is important to level out the existing inequities as much as we can by reaching out to those who are underrepresented and allow easy access to investigational vaccine clinical trial participation.”
Who’s eligible, and how will the trial work?
Study participants must be 18 or older and have not previously tested positive for COVID-19. The study is a randomized placebo-controlled clinical trial, the “gold standard” for testing. That means that volunteers are randomly assigned — that is, selected by chance. In this case, for every two people who receive the investigational vaccine, one will receive a placebo. The participant will receive two doses, 21 days apart. Participants cannot get COVID-19 from the vaccine, as it does not contain a live virus.
Those who are more likely to be at increased risk of SARS-CoV-2 infection due to community exposure, such as working in jobs that require public interaction, are encouraged to participate. People who are in stable health with preexisting conditions — such as obesity, type 2 diabetes, and chronic kidney, lung or cardiovascular disease — that put them at a higher risk for developing severe health complications as a result of COVID-19 are also encouraged to participate.
“We cannot emphasize enough the importance of clinical trial participation when it comes to novel infections we don’t know yet how to prevent or treat completely effectively,” said co-investigator Sharon Nachman, MD, and Associate Dean for Research at the Renaissance School of Medicine at Stony Brook University. “The hope is that people who receive the vaccine will be less likely to develop COVID-19 infection and less likely to develop severe disease as compared to those who get the placebo.”
A reason for hope
The Novavax Phase Three study began in the UK in September and at selected centers across the US in December. This randomized, observer-blinded, placebo-controlled trial — the gold standard for clinical trials — is the fifth major trial supported by Operation Warp Speed, the federal government effort to bring a coronavirus vaccine to market.
“We are particularly excited about this pivotal Phase Three study because of the promising results of earlier safety studies, and because it uses the structure of the SARS-CoV-2 spike protein, which has been shown to have a high efficacy in other major vaccine trials,” said Dr. Luft.
The Novavax vaccine developmental approach is what’s known as a recombinant nanoparticle vaccine, which is derived from the coronavirus surface or “spike” protein. It is used in combination with a proprietary adjuvant, a compound that is designed to boost the immune response and stimulate high levels of neutralizing antibodies. It does not contain viral material and cannot replicate causing infection. The investigational vaccine can be shipped and stored at two to eight degrees Celsius, allowing for greater ease of distribution.
“Participation in this clinical trial gives us an important opportunity to contribute to this global effort of finding hope for the future, especially for those who are most vulnerable to the disease,” said Dean Kaushansky. “With our close proximity to what was once the epicenter of the virus, our Stony Brook Medicine community at the frontlines gained key insights early to help save lives, and now we are eager to scale our efforts up even further to help bring a successful vaccine to defeat the COVID-19 pandemic.”
Learn more about the clinical trial now by reading our frequently asked questions. Have other questions or want to discuss the vaccine clinical trial? Please call us at (631) 638-COVID (2684) or email SBRVP_Research@stonybrookmedicine.edu.