2nd-generation COVID-19 vaccine trial seeks volunteers

Researchers at the University of Washington School of Medicine are enrolling volunteers in an investigational COVID-19 booster vaccine trial.

This study is recruiting COVID-19-vaccinated and boosted persons interested in receiving additional investigational  vaccination against SARS-CoV-2, the virus that causes COVID-19.

The Gritstone second-generation vaccines are different from the currently available COVID-19 vaccines. They are designed to generate immune responses to multiple SARS-CoV-2 proteins, in addition to the spike protein targeted by vaccines now in use that are made by Moderna, Pfizer or Johnson & Johnson.

By targeting several coronavirus proteins, the investigational vaccines may provide enhanced protection against a wide variety of SARS-CoV-2 strains and variants. The vaccine candidates were developed by Gritstone bio, a biotechnology company headquartered in Emeryville, California.

“As the SARS-CoV-2 virus continues to change, we need to consider modifying our vaccines to cover both emerging and future variants,” said Dr. Anna Wald, professor of medicine, epidemiology, and laboratory medicine and pathology, director of the Virology Research Clinic in Seattle and the site principal investigator of the trial. 

“We are looking for all interested healthy persons and we encourage persons older than 60 years old to apply,” said Dr. Tia Babu, acting assistant professor of medicine in the Division of Allergy and Infectious Disease at the UW School of Medicine and one of the trial investigators.

To enroll, participants must be age 18 or older and have been vaccinated and boosted against COVID-19 at least four months prior to enrollment.

Participants will be asked to:

• Make 7 to 14 or more study clinic visits in-person and  also receive one to two telephone check-ins with the study staff over the study period.
• Receive one or two injections of an investigational booster vaccine.
• Have blood drawn several times to see whether the vaccine resulted in an immune response.
• Keep track of how they’re feeling after the injection.

Interested people should visit: www.uwvteu.org, click on “Join the Participant  Registry” and fill out a short survey. The Virology Research Clinic Team will contact you if you are eligible for a study. You can also email  vteu+gritstone@uw.edu or call 206-520-4212.  

For more information about the COVID-19 clinical trials at UW, visit ClinicalTrials.gov. The study’s Clinical Trials Identifier is NCT04776317.

This study is sponsored and funded under grant UM1 AI148573 by the U.S. National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and is being conducted through the NIAID-supported Infectious Diseases Clinical Research Consortium.

This activity is supported by the Infectious Diseases Clinical Research Consortium through the National Institute of Allergy and Infectious Diseases  (grant 5UM1AI148684-03). The IDCRC, consisting of the Vaccine Treatment and Evaluation Units and the IDCRC Leadership Group, was formed in 2019 to support the planning and implementation of infectious diseases clinical research that efficiently addresses the scientific priorities of NIAID. 

The consortium includes infectious diseases leaders and clinical researchers from Emory University, University of Maryland School of Medicine, Baylor College of Medicine, Cincinnati Children’s Medical Center and University of Cincinnati, FHI360, Fred Hutchinson Cancer Research Center, Johns Hopkins University, Kaiser Permanente Washington Health Research Institute, New York University, Saint Louis University, Vanderbilt University Medical Center, University of Alabama at Birmingham, University of Rochester, University of Washington, and NIAID.

For more information about the IDCRC, please visit www.IDCRC.org.

For details about UW Medicine, please visit http://uwmedicine.org/about.