The Brigham is playing key roles in a clinical trial of a potential vaccine for preventing COVID-19.
The COVE (Coronavirus Efficacy) study will enroll 30,000 participants at trial sites nationwide, including four locations at the Brigham, to evaluate mRNA-1273, a vaccine candidate manufactured by Cambridge pharmaceutical company Moderna, Inc.
The trial is the country’s first COVID-19 vaccine candidate to enter Phase 3. In research studies, phases 1 and 2 establish safety and effectiveness, respectively, with small populations. Phase 3 trials seek to validate those findings in larger groups of people.
The Brigham is serving as a clinical research site as part of the COVID-19 Prevention Network (CoVPN), funded by the National Institutes of Health (NIH). Multidisciplinary teams will support the trial at the Brigham’s main campus, Brookside Community Health Center, Southern Jamaica Plain Health Center and 830 Boylston St. in Chestnut Hill.
Lindsey Baden, MD, an infectious diseases specialist at the Brigham and an expert in vaccine development for viral diseases, will serve as co-principal investigator for the COVE study.
“This is the first Phase 3 trial in the U.S. that will test the effectiveness of a vaccine against COVID-19, and we’ve been working diligently across industry, academia and government to pave a path for launching this trial rapidly and safely,” said Baden. “Our goal has been to not only launch this important trial, but also to develop a rapid, high-quality process for future vaccine trials to come.”
Study participants will be randomized to receive either two injections of the investigational vaccine or a saline placebo. The trial is blinded, so the investigators and the participants will not know who is assigned to which group. Researchers will follow up with participants for two years to closely monitor their safety and to better understand how the vaccine works over a longer term. More details about participating in the COVID vaccine study are available on the Rally for Partners site.
The COVE study is part of Operation Warp Speed (OWS), a national initiative that aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by early 2021. Additional Phase 3 vaccine trials are being planned by the CoVPN in conjunction with pharmaceutical companies.
Engaging the Local Community
The target population for this study are adults whose locations or circumstances put them at increased risk of exposure to COVID-19 due to age, underlying medical conditions, location or other circumstances that increase risk. To ensure these populations have knowledge about the vaccine trials and access to participate, the Brigham research team has made community outreach a cornerstone of the trial. The team hopes to enroll 25 to 40 percent of participants from such groups.
“We need to understand how to develop a vaccine for everybody. We won’t have a successful vaccine if we don’t know that it works in all of us,” said Baden, an expert in developing novel diagnostics and therapeutics for viral diseases that disproportionately affect high-risk patients who serves as the Brigham’s vaccine clinical research site leader for the Harvard HIV Vaccine Clinical Trials Unit.
“COVID has taught us that we are one community,” he added. “A problem anywhere in the world is everywhere. We can’t get out of this problem unless we address it in all communities that are affected.”
This includes partnering closely with communities of color, particularly Boston’s Black and Latinx populations, who have experienced disproportionately higher rates of infection and death from the disease due to systemic inequities in housing, jobs and health care placing them at greater risk.
Paramount to this work is building trust with these communities and “acknowledging the painful history of racism in research that has devastated communities of color and, understandably, led to a deep mistrust of health care and research,” said Christin Price, MD, program director of Medicaid ACO/E-Care Optimization in Brigham Care Strategies & Innovation.
“We need to reframe our approach so that we really listen and understand the concerns and fears many people may have about a study like this, and we need to continue to do so throughout the duration of the trial — not just at the time of recruitment,” she said. “We are committed to creating equitable opportunities to participate without placing an undue burden on communities of color. Our goal is to enroll patients that could be at high risk for COVID-19 infection, whether that be a result of age, medical conditions, occupational exposure or living in a community that has had high rates of COVID-19.”
To help accomplish this, Brigham faculty and staff are hosting a series of virtual and in-person events for residents and partners at community-based organizations to learn more about the trial and ask questions.
“People want to learn about these opportunities, and it is our responsibility to bring this knowledge to the community,” said Rich Joseph, MD, medical director of the Brigham and Women’s Hospital’s Center for Community Wellness at Sportsmen’s Tennis & Enrichment Center in Dorchester, who recently hosted an educational webcast with Baden and interactive Q&A session for local residents.
Primary care providers at the Brigham can also play a vital role in helping get the word out, said primary care physician and epidemiologist Paulette Chandler, MD, MPH, who is leading the community engagement and recruitment efforts for the trial.
“We’re hoping more clinicians become involved in the education and recruitment process because those one-on-one discussions between providers and patients are critical, particularly when it comes to addressing patients’ questions and concerns,” Chandler said.
In addition, the team is collaborating with colleagues at Brookside and SJPHC to host in-person information and enrollment tables with bilingual staff alongside the community health centers’ ongoing COVID-19 testing, food distribution and social determinants of health screening events.
“It is important that we make a concerted effort to engage neighborhoods and communities that were disproportionately affected by COVID-19 and could be at higher risk if we see a resurgence,” said Price, who is helping coordinate the team’s work with the community health centers. “These are the communities that would benefit the greatest from an effective vaccine, and so I believe it is our duty to ensure that members of these communities, if interested, have access to a potentially lifesaving discovery.”