IDCRC researchers study several COVID-19 variant vaccines

March 29, 2022

Researchers and leadership from the Infectious Diseases Clinical Research Consortium (IDCRC) and other sites across the country (in collaboration with NIAID) have launched a Phase 2 clinical trial to evaluate the safety and efficacy of additional doses of prototype and variant (alone or in combination) COVID-19 vaccine candidates in previously vaccinated participants with or without prior SARS-CoV-2 infection. The COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial) will also evaluate innate, cellular and humoral immune responses to inform on how to shift the immune response to cover new SARS-CoV-2 variants as they emerge. This research is crucial to inform decisions about additional booster doses to protect against rapidly evolving variants.

“The COVAIL study is addressing an important public health need by testing different potential booster shots of variant vaccines to expand and optimize immune coverage to existing and emerging antigenic variants,” says Nadine Rouphael, MD, MSc, study co-principal investigator and executive director of the Hope Clinic at the Emory Vaccine Center.

Participants will include individuals 18 years of age and older who are in a stable state of health and have received a complete authorized/approved vaccine series (primary series and booster either with homologous or heterologous vaccine products) 16 weeks prior to enrollment. Participants will be stratified by age and history of confirmed prior SARS-CoV-2 infection, and randomly assigned to receive one of several variant vaccines. Enrollment will be open to all age groups including older adults and those with or without confirmed COVID-19. The trial aims to enroll 600 participants at 24 sites across the country, 12 of which are IDCRC sites. The primary objective is to evaluate humoral immune responses of candidate SARS-CoV-2 variant vaccines, alone or in combination.

“The SARS-CoV-2 virus will continue to evolve over time, leading potentially to new variants and the possibility of periods of higher incidence of symptomatic disease,” says Angela Branche, MD, study co-principal investigator and associate professor at the University of Rochester. “Our hope with the COVAIL study is to move from responsiveness to preparedness.” 

Visit ClinicalTrials.gov for additional details. This study is being conducted in collaboration with academic medical centers across the US, NIAID’s Infectious Diseases Clinical Research Consortium and the NIAID SARS-CoV-2 Assessment of Viral Evolution (SAVE) Program.

Participating IDCRC Sites:

  • Emory Children's Center - Vaccine Research Clinic
  • Emory Vaccine Center - The Hope Clinic
  • University of Illinois at Chicago College of Medicine - Division of Infectious Diseases
  • Saint Louis University - Center for Vaccine Development
  • Washington University School of Medicine in St. Louis - Infectious Disease Clinical Research Unit
  • NYU Grossman School, NYU Langone Vaccine Center, Long Island site
  • NYU Langone Vaccine Center Research Clinic, Manhattan site
  • University of Rochester Medical Center - Vaccine Research Unit
  • Baylor College of Medicine - Molecular Virology and Microbiology
  • University of Texas Medical Branch - Division of Infectious Disease
  • Kaiser Permanente Washington Health Research Institute - Vaccines and Infectious Diseases
  • The University of Washington - Virology Research Clinic

About Infectious Disease Clinical Research Consortium (IDCRC)
This activity is supported by the Infectious Diseases Clinical Research Consortium (IDCRC) through the National Institute of Allergy and Infectious Diseases (NIAID) (UM1AI148684). The IDCRC, consisting of the Vaccine Treatment and Evaluation Units (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. 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.