Volunteers needed for expanded COVID-19 booster trial

New arm of NIAID-sponsored mix-and-match trial will look at Novavax protein vaccine

Kaiser Permanente Washington Health Research Institute (KPWHRI) is recruiting volunteers in the Seattle area for a study exploring the possible benefits of the Novavax vaccine as a booster for people who have gotten the Moderna, Pfizer, or Johnson & Johnson COVID-19 vaccine for their initial series.

The study is a new arm of the ongoing mix-and-match COVID-19 vaccine booster trial, a national clinical trial funded by the National Institutes of Health (NIH).

The Novavax COVID-19 vaccine is a protein-based coronavirus vaccine that uses a method of developing virus proteins that’s similar to what’s used to make licensed vaccines for influenza and HPV (human papillomavirus). This differs from the methods used by the Moderna and Pfizer COVID-19 vaccines, which employ mRNA technology.

The mix-and-match COVID-19 vaccine booster trial includes KPWHRI and 8 other research centers in the Infectious Diseases Clinical Research Consortium (IDCRC). The study aims to assess the use of different boosters that may or may not match the type of vaccine that participants received earlier. The researchers aim to determine the safety and effects of mix-and-match boosters on immunity to SARS-CoV-2, the coronavirus that causes COVID-19.

“In this new arm of the study, the question is whether protein-based Novavax COVID-19 vaccines can induce a more effective immune response,” said Lisa A. Jackson, MD, MPH, who is leading the trial at KPWHRI. “Previous research on other infectious diseases indicates that mixing vaccine types can lead to stronger immunity, so it makes sense to include the Novavax vaccine in our study and investigate how this works for COVID-19.”

To gauge the potential efficacy, researchers will test how the different matches of vaccine and booster affect the levels of antibodies that help to produce an immune response to the coronavirus. The study will also track adverse events to assess the safety of the different pairings.

Participating in the trial

This arm of the clinical trial is currently enrolling healthy individuals age 18 and older who have received exactly 2 doses of a COVID-19 vaccine: 2 (and only 2) doses of Moderna, or 2 (and only 2) doses of Pfizer, or 2 (and only 2) doses of Johnson & Johnson.

Participation in the study involves receiving one study COVID-19 booster vaccination and having several follow-up visits. Participants will receive $75 for each research clinic visit. Seattle-area residents who are interested in participating can join the KPWHRI vaccine trial registry at https://corona.kpwashingtonresearch.org/ or email kpwa.vaccine@kp.org for more information.

Additional information about the trial is available on the clinicaltrials.gov website, maintained by the National Library of Medicine at the NIH.

The study is being conducted by the IDCRC in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH. The co-principal investigators of the trial are Robert Atmar, MD, professor of infectious diseases, Baylor College of Medicine, and Kirsten E. Lyke, MD, professor of medicine, University of Maryland School of Medicine.

The trial is slated to run through 2025, although preliminary results may be available in several weeks.

In addition to KPWHRI, the other participating IDCRC sites are Baylor College of Medicine Vaccine and Treatment Evaluation Unit (VTEU); University of Texas Medical Branch at Galveston, subsite of Baylor VTEU; Cincinnati Children’s Hospital Medical Center VTEU; Emory University VTEU; University of Rochester VTEU; New York University VTEU; University of Washington VTEU; and University of Pittsburgh, subsite of Vanderbilt VTEU.

The IDCRC, consisting of the VTEUs 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.