Led by Cindy Gay, MD, clinical researches in the UNC Division of Infectious Diseases are leaning on years of experience and expertise to partake in a large phase 3 clinical trial for a COVID-19 vaccine.
In February 2020, as bits of data about the SARS-CoV-2 virus started to emerge, Cindy Gay, MD, MPH, and UNC infectious diseases colleagues began meeting to formulate a local response to the virus. They’ve met weekly ever since, resorting to Zoom calls once the university sent employees home in March. They’ve shared data, compared notes with colleagues globally, and updated treatment recommendations.
In June, Gay agreed to lead the phase 3 clinical trial UNC site for a potential COVID-19 vaccine. Sites across the country are testing the mRNA-1273 vaccine developed by Moderna in a large-scale study aiming for 30,000 participants. Gay and her team — which includes David Wohl, MD, and Joseph Eron, MD, chief of infectious diseases — hope to start seeing participants by mid- to late August. They are developing sites in Chapel Hill and surrounding communities that will offer safe and easy access for participants, away from UNC Hospitals.
The potential Moderna vaccine is one of a handful of treatment and prevention studies launching soon to fight COVID-19. The National Institutes of Allergies and Infectious Diseases created the COVID Prevention Network (CoVPN) to coordinate the multiple studies. The network maximizes the strength of four existing clinical trials networks established to study HIV prevention, including the HIV Prevention Trials Network (HPTN) based at Family Health International in Durham, NC. Myron Cohen, director of UNC’s Institute for Global Health and Infectious Diseases (IGHID), is co-principal investigator for HPTN and a leader of the new CoVPN.
“We’re building on well-established networks,” Gay says. “Everyone in CoVPN has great experience in large, multi-site studies.”
“In order to respond to the COVID-19 pandemic, we need to develop both effective treatment and prevention strategies,” Eron says. “An effective vaccine is a critical component of that response. Our dedicated research team in ID and IGHID is fully engaged in this critical effort.”
For Gay, the shift to COVID clinical trials has been as seamless as possible in the face of a global pandemic. She has a deep background in HIV research, developing protocols, directing large-scale studies, and supporting basic scientists. She has served as principal investigator and co-chair of large-scale HPTN studies and as medical director for UNC’s HIV Cure Center trials. Similar to the Moderna vaccine, both the HPTN and HIV Cure trials involve infusion and injection treatments.
One of her team’s greatest challenges is reaching their target participants. “We are committed to making this study available to the populations who are most affected by the disease in our community,” Gay says. This includes people of color and the elderly. “The challenge is building trust and making them want to participate,” she adds. “The LatinX community has historically not been approached for clinical trials, and they may be undocumented, so they have legitimate trust issues with healthcare and with the government.”
Other communities have concerns with clinical research as well. And within all communities, there are basic concerns regarding new vaccines.
Potential candidates sign up to be screened for the study through a national registry, where their degree of risk for acquiring COVID-19 is assessed. Phase 3 trials confirm and expand on Phase 1 and 2 trials by evaluating a large number of people, in this case ideally those who are at increased risk for COVID-19, so that the effectiveness of the vaccine can be determined.
Gay is pleasantly surprised by how her UNC Health colleagues are offering to pitch in on recruitment. “They know we need to reach out to populations at risk, like the LatinX community and nursing home residents. Colleagues are offering to help recruit patients from their clinics. It’s really remarkable, I haven’t seen this kind of generosity before.”
Moderna has brought its vaccine candidate to trials with unprecedented speed, but Gay notes that none of the precautions for participants have been shortchanged. “The acceleration comes not in skipping any of the safety steps of three-phase trials but in speeding up all the other research components. All the different groups that have to review and approve the studies; they’ve all had to make this a priority instead of having a year to do so,” she says.
Locally, Gay’s challenges include ramping up a large-scale study and trying to hire staff with less support, with most of the IGHID staff working remotely.
“A lot of people are working hard, long hours with less support, no doubt,” she says. “But our infectious diseases group is made up of very committed, purpose-driven individuals. And that purpose-driven mindset keeps you going. We know that we have to think about this as a marathon,” she says, “not a sprint.”
Gay is asked often about how soon we’ll have an effective COVID vaccine. She can’t really say how quickly it will be available, but she feels sure that it will be developed. “With the coronavirus, we’re not dealing with issues of rapid mutation like we are with HIV,” she says. “We have a great track record of responding quickly to viruses, and advances in technology are helping us. I feel quite hopeful.”
Written by Lisa Watts, communications manager for the UNC Institute for Global Health and Infectious Diseases.