Second-generation COVID-19 vaccine clinical trial starts

UW Medicine investigators are starting volunteer enrollment for a clinical trial evaluating an investigational, second-generation COVID-19 vaccine. The Phase 1 multicenter study will examine safety, tolerability, and immune response for different doses of a two-part, investigational COVID-19 vaccine regimen. The second stage of the study will include vaccines with multiple SARS-CoV-2 proteins, in addition to the components of Spike protein used in the current COVID-19 vaccines given under FDA Emergency Use Authorization.

UW Medicine’s site for enrolling participants will be located at the Virology Research Clinic at Harborview Medical Center’s Ninth and Jefferson Building. It plans to enroll up 40 healthy volunteers. In this early-study, participants must be age 18 and older, healthy, and at low risk for SARS-CoV-2 infection.  Interested participants should contact:

• UW Virology Research Clinic
  • Email: gritstone@uw.edu
  • Call: 206-520-4340
  • Visit: ClinicalTrials.gov for more information,  Clinical Trials Identifier: NCT04776317

Participants will be asked to:

• Commit to coming in for 8 to 9 or more study clinic visits and participating in 4 telephone visits over 13 to 16 months, receiving two injections of vaccine, and having several blood draws for safety monitoring and to see whether the vaccine resulted in an immune response.
• Keep track of how they’re feeling after each injection. The study staff will also be in contact with each participant.
• The results of the immune tests in each vaccinated group will be shared with the participants a few months after the second vaccine.

“We know that mutations in the Spike protein have led to the emerging variant strains of the COVID-19 virus.  We hope that the addition of multiple COVID-19 immune targets to our vaccines, in the second stage of our study, will broaden the immune response and include protection against emerging variant strains,” said Dr. Anna Wald, professor of medicine, laboratory medicine and pathology and director of the Virology Research Clinic at the University of Washington School of Medicine, and the site principal investigator of the trial. She is also a professor of epidemiology at the UW School of Public Health.

Dr. Tia Babu, acting assistant professor of medicine in the Division of Allergy and Infectious Disease at the University Washington School of Medicine, is a sub-investigator working with Wald.  Babu added,  “As this is a Phase 1 study, we will be recruiting healthy participants who are at low risk for developing severe disease from COVID-19.”

The study is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institues of Health, is being conducted through the NIAID-supported Infectious Diseases Clinical Research Consortium.

This second-generation COVID-19 vaccine candidate was developed by Gritstone, a U.S.-based clinical-stage biotechnology company, under its “CORAL” COVID-19 program with support from departments within the NIH and the Bill & Melinda Gates Foundation and a license agreement with La Jolla Institute for Immunology.

Researchers at UW Medicine have been on the forefront in the battle against COVID-19 since the outbreak began. They were the first to detect widespread community spread of SARS-CoV-2 in the U.S. They were co-investigators in a major international trial that found the drug remdesivir helped patients with severe disease. UW Medicine scientists are conducting basic research into COVID-19, including analyzing body’s immune response to the virus in the hope of perhaps developing antibody therapies and other treatments to fight the infection. In addition, UW Medicine has been a model for how institutions can effectively respond to COVID-19, with multiple guidelines that have been shared with other hospitals via https://covid-19.uwmedicine.org/.

The Infectious Disease Clinical Research Consortium, 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 National Institute of Allergy and Infectious Disease. 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 the National Institute of Allergy and Infectious Diseases.

 

 

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