UW Medicine to Run Mix-and-Match COVID Vaccine Booster Trial


Researchers with UW Medicine are among those at 12 sites nationally that will be studying whether a single dose of the Johnson & Johnson vaccine will keep COVID-19 and its scary variants away. And they need volunteers to help.

The purpose of the clinical trial, which is sponsored by the National Institute of Allergy and Infectious Diseases, is to test the safety and effectiveness of additional doses of vaccines in people who have already received emergency-use authorized vaccines.

The three vaccines that have been approved for emergency use in the U.S. are made by Pfizer, Moderna and Johnson & Johnson.

The trial could also indicate whether getting a booster with a different vaccine platform provides broader protection as immunity wanes or helps fight against variants, said Dr. Christine Johnston, principal investigator and an associate professor of medicine at UW Medicine's Division of Allergy and Infectious Diseases.

"It is possible that immunity may decrease with time after vaccination, which could make it more difficult to prevent COVID-19, particularly if there are variants of concern circulating," she said Monday.

The delta variant is responsible for surges in cases across the world, including 95% of the new infections in Britain where more than 50% of the population has been fully vaccinated.

The study will enroll two groups:

* Group 1: Participants who have gotten two doses of Pfizer or Moderna or one dose of the J&J vaccine at least 12 weeks before joining the study.

* Group 2: Participants who have not previously received any of the U.S.'s authorized vaccines, but are willing to be vaccinated. This second group will receive the two-shot Moderna series as part of the study, and may receive a booster shot later.

To be eligible for the trial, you must:

* Be 18 years of age or older.

* Have become fully vaccinated against COVID-19 no less than 12 weeks ago; or be willing to receive an initial COVID-19 vaccine, in addition to the booster.

* Have not tested positive for COVID-19.

* Are not currently pregnant or breastfeeding.

* Do not have a history of serious reactions to vaccines.

For completing the entire study, which will last about one year and involve at least seven to 11 in-person visits, participants in Group 1 will be paid $800, while those in Group 2 will be paid $1,400.

"We just want to be ready for whatever this virus throws at us," Johnston said.

"We want to have the evidence about whether boosters are effective or not," Johnston said in a UW announcement. "Right now, I think we still need a lot more data to understand when to get boosters, how to get them, how to phase them, the timing.  And so that is exactly what this trial is trying to address."