Researchers at the University of Washington School of Medicine are enrolling volunteers for a COVID-19 booster vaccine trial. Volunteers will participate in the second stage of a phase 1 vaccine trial. Phase 1 vaccine trials are designed to test the safety and tolerability of and immune response to a new vaccine.
In the first stage of the trial, the experimental vaccines were given to unvaccinated volunteers. In this second stage, the vaccines will be given as a booster shot to volunteers who have already been vaccinated against SARS-CoV-2.
Unlike current vaccines, the trial vaccines seek to elicit an immune response to multiple SARS-CoV-2 proteins in addition to the spike protein that is targeted by currently available vaccines made by Moderna, Pfizer and Johnson & Johnson.
The hope is that by targeting a number of coronavirus proteins, the vaccine will provide protection against a wide variety of SARS-CoV-2 strains and variants. The vaccine candidates were developed by Gritstone bio, headquartered in Emeryville, CA.
“With the emergence of the Delta and other COVID-19 variants, we need to stay ahead of the virus by developing effective vaccines that will aid in the prevention of all strains of COVID,” said Dr. Anna Wald, director of the UW Medicine Virology Research Clinic and head the UW School of Medicine’s allergies and infectious diseases division. She is the trial site principal investigator.
“We hope that these investigational vaccines enhance and broaden the immune response elicited by vaccines currently available in the U.S.,” said Dr. Tia Babu, acting assistant professor at the University of Washington School of Medicine and a trial investigator.
To enroll, participants must be age 18 or older, healthy, without significant allergies, without a history of prior SARS-CoV-2 infection and have been vaccinated against COVID-19 at least four months prior to enrollment. Persons over age 60 are encouraged to participate.
Participants will be asked to:
- Make nine to 14 or more in-person clinic visits and also will receive one to two telephone check-ins with study staff over 12 to 14 months.
- Receive one or two injections of investigational vaccine.
- Have blood drawn several times to monitor safety and to see whether the vaccine results in an immune response.
- Keep track of how they’re feeling after the injection.