University of Rochester vaccine researcher Angela Branche M.D. has been named national co-chair of a National Institutes of Health-sponsored study to test the effectiveness of new formulations of mRNA COVID-19 vaccines.
Branche, who along with vaccine researcher Anne Falsey M.D. co-chairs the UR Medical Center’s Vaccine Evaluation and Treatment unit, shares leadership of the NIH study with Nadine Rouphael M.D., director of the Hope Clinic at the Emory University’s Emory Vaccine Center in Atlanta.
The 12- to14-month, Phase II clinical trial kicks off as the Centers for Disease Control recommend a fourth shot for mRNA-vaccinated and boosted individuals over the age of 50 with chronic illnesses and people whose immune systems are compromise.
While protection against serious illness and hospitalization remains strong in those inoculated against COVID, Branche says, the CDC’s authorization of second booster acknowledges “what we know: that immunity does wane (and that) we have to continue to protect people, particularly those who are most at risk—adults over the age of 50 with underlying conditions as well as those who are immunocompromised.”
In a statement, Anthony Fauci M.D., director of NIH’s National Institute of Allergies and Infectious Diseases, describes the trial’s aim as “looking beyond the Omicron variant to determine the best strategy to protect against future variants.”
The trial seeks to tell researchers “if we can use prototype and variant vaccines alone or together to shift immune responses to cover existing and emerging COVID-19 variants,” Fauci explains.
The study also looks to head off the possibility that future COVID variants might develop the ability to overcome the immunity current vaccines provide.
Researchers have determined that third shots of mRNA vaccines or second shots of Johnson & Johnson’s single-dose COVID vaccine given as boosters strengthen immune response, Falsey says. Whether a fourth shot also adds protection is not fully established. This study hopes to determine whether additional boosters provide similar added protection.
Dubbed the COVID-19 Variant Immunologic Landscape or COVAIL for short, the vaccine study needs to enroll 600 volunteers nationwide. Participants must have already received two shots of an mRNA COVID vaccine and one booster at least four months ago.
Volunteers accepted for the COVAIL trial will be inoculated either with a shot of the standard Moderna vaccine or dosed with one or two of several newly formulated mRNA vaccines tailored to combat the virus’ Omicron, Beta or Delta variants. Some will get shots combining two specially formulated vaccines and others will be asked to get two new booster shots.
Branche is optimistic about finding a sufficient number of volunteers here and at other academic medical centers around the country conducting the trial. Though the study hasn’t been widely publicized, four individuals—two in Rochester and two in Atlanta—have already enrolled, Branche says. Researchers plan to recruit volunteers over the next month.
The new formulations have already been through Phase I tests and all have been determined to be at least as effective as the prototype Moderna shot, Branche says. The trial will test whether newly formulated vaccines provide better protection and determine what side effects, if any, the new formulations might have.
Anyone wanting to sign up as a volunteer for the Rochester study should visit covidresearch.urmc.edu or call 585-273-3990.