A university in D.C. is participating in what Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, called a “truly historic event”—and it’s looking for volunteers to help make that happen.
The country’s first final-stage clinical trial of a potential coronavirus vaccine began on Monday, and George Washington University will be among 89 sites around the country to test the experimental vaccine on hundreds of volunteers. According to the university, it is the only site in D.C. to be selected by the National Institutes of Health, and the university is still looking for applicants willing to take the vaccine.
Researchers around the globe are developing over 150 coronavirus vaccines, and only five—including one in the U.S.—are in phase three of testing. Phase three means a vaccine is being monitored for efficacy, so researchers give a vaccine to thousands of people to see how many get infected as compared to those given just a placebo. The vaccine now in phase three is developed by the biotechnology company Moderna in partnership with the National Institutes of Health.
The vaccine uses genetic material from the virus, called mRNA, to trigger an immune response. Results in the phase one trial published in the New England Journal of Medicine were promising, and appeared safe and generated an immune response in 45 people tested. Now, the vaccine will be tested on 30,000 volunteers nationwide, including 500 in the clinical trial at GW. The hope is two doses of the mRNA vaccine will prevent people from catching COVID-19 or stop those with the disease from getting sick or dying.
“If we do have a very effective vaccine that prevents people from getting sick from the infection, then we could conceive of life going back to relative normal—if a sufficient number of people actually got vaccinated to interrupt transmission, so we don’t have to worry anymore,” says Dr. David Diemert, a professor of medicine at the GW School of Medicine and Health Sciences and the principal investigator of the clinical trial at the university.
“I just hope that people are willing to and wanting to participate,” says Elissa Malkin, an assistant research professor of medicine at GW School of Medicine and Health Sciences and co-investigator on the trial. “It’s really making a contribution to the future, not just to today.”
Moderna’s mRNA vaccine is being developed at an accelerated speed: It typically takes years of research and testing to develop new vaccines. It has also not yet completed the second phase of its clinical trial, which the Food and Drug Administration notes can occur in cases where phase one trial results appear promising. In phase one of a vaccine trial, an experimental vaccine is tested for safety and dosage on a small group of people, while in phase two, researchers widen the scope of their testing and administer the vaccine among a larger and more diverse range of participants.
The clinical trial comes as pressure continues to mount on researchers, including from the president, to develop a coronavirus vaccine. Nearly 12,000 people in D.C. alone have tested positive for the virus, and over 580 have died; nationally, there are about 4.4 million known cases of the virus, and over 150,000 deaths.
“Despite the pressure and the fast pace, no corners are being cut,” says Diemert, “And definitely there’s no compromise being made on assessment of safety. So there’s lots of safety checks that are being built into all of these studies so that we can pick up potential safety issues if there are any and act accordingly.”
“There’s no compromise on scientific integrity,” he says.
The GW site “activates” Friday and enrollment in the trial will begin next week. The hope is to give all 500 volunteers the first of two doses within two months time. The injections are in the arm muscle, like the flu vaccine, and are spaced one month apart. Half the volunteers will receive a saline placebo, not a vaccine.
Participating in the trial
GW is enrolling residents 18 or older who live in the DMV region. Those who have contracted COVID-19 aren’t eligible, because it remains unclear to researchers whether having the disease makes patients immune to getting it again. Those who have compromised immune systems are also ineligible to participate.
What will it mean for the 500 volunteers? According to Diemert, no one needs to change their daily habits to participate in the phase three trial. Volunteers will be regularly monitored for symptoms and side effects, with researchers following up routinely for two years after the second injection. There are at least seven in-person visits required of volunteers, while the rest of the check-ins are done virtually, either by computer or phone. Volunteers can visit the university’s Foggy Bottom clinic, mobile van, or a trailer on loan by the Department of Defense. Volunteers will also keep track of any symptoms they experience in a journal. Compensation is provided for every visit volunteers make to the university, totaling just over one thousand dollars at the end of the two years.
The first person to be given a shot for the phase three trial was a woman in Savannah, Georgia on Monday at 6:45 a.m. The volunteer, Dawn Baker, does not know if she got the vaccine or placebo. “It’s a very important role to have and be part of that research,” Baker tells CNN. “I never thought I’d do something like this.”
Getting a diverse group of volunteers is key for GW—diverse in age, health status, ethnicity and race. Researchers want to include participants from communities that have been disproportionately impacted by COVID-19. In D.C., the Latinx community has seen the highest rate of COVID-19 infections, while the Black community has seen the highest rate of deaths related to COVID-19. Researchers also want to include individuals in industries hardest hit by the pandemic, so GW is conducting targeted outreach to employees of the restaurant and construction industries, as well as institutions like unions, churches, and senior living facilities. All study materials have been translated into Spanish.
“We want to help and we want to end up with something that’s going to help them,” says Diemert.
People of color are underrepresented in research. There are a host of reasons why. The horrific Tuskegee Syphilis Studies, for example, has also caused lasting mistrust between Black people and the medical establishment. There’s also federal law that seeks to protect vulnerable populations from medical exploitation.
The GW team is acutely aware of this. The study is in partnership with the NIH-funded GW HIV Prevention Trials Network clinical research site, led by Dr. Manya Magnus, a professor of epidemiology at GW’s Milken Institute School of Public Health.
“They have been working on primarily HIV prevention research for several years and have a very strong history and expertise in reaching out to underserved and minority communities to participate in such studies, because in the past HIV prevention studies have not always enrolled diverse populations,” saysDiemert.
Other sites in the region selected to participate are in Baltimore, through the University of Maryland and Johns Hopkins University.
“We have the expertise. We have the person-power in order to be able to do such a big study. And we all think it’s a really important thing to work on,” says Diemert. “We know we need something because a pandemic has shown no signs of abating.”