IDCRC launches COVID-19 vaccine trial for young children

Moderna’s mRNA-1273 vaccine, the KidCOVE Study

Researchers from Infectious Diseases Clinical Research Consortium (IDCRC) sites across the country are participating in a clinical trial testing Moderna’s COVID-19 vaccine in children ages six months to less than 12 years.

This is the same Moderna mRNA-1273 vaccine that is being distributed nationwide for adults following an emergency use authorization from the U.S. Food and Drug Administration in December. The initial phase of the KidCOVE study will test different doses of the vaccine to evaluate safety in a younger population.

The study is being conducted by the IDCRC in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority.

Moderna, trial sponsor, is testing its mRNA-1273 COVID-19 vaccine in three dose levels in healthy children ages six months to less than 12 years. The phase 2/3 study will be conducted in two parts to evaluate the safety and effectiveness of the investigational vaccine to protect against SAVS-CoV-2, which causes COVID-19, by administering two doses of mRNA-1273 given 28 days apart. This study will enroll approximately 6,750 pediatric participants in the U.S. and Canada.

 Participating IDCRC sites:

  • Vanderbilt University Medical Center Vaccine and Treatment Evaluation Unit (VTEU)
  • University of Maryland School of Medicine VTEU
  • Emory University VTEU Emory Children’s Center – Vaccine Research Center
  • Baylor College of Medicine VTEU
  • University of Rochester VTEU
  • Cincinnati Children’s Hospital Medical Center VTEU
  • Children’s Hospital of Philadelphia, subsite of Vanderbilt VTEU
  • University of Pittsburgh, subsite of Vanderbilt VTEU
  • Washington University in St. Louis, subsite of Vanderbilt VTEU

“This is a critical step for younger children and could make it possible for them to receive the same type of immune protection now provided to adults by vaccination,” says Evan Anderson, MD, attending physician at Children’s Healthcare of Atlanta and Emory University School of Medicine and the study co-principal investigator. 

“We know from a previous Phase 3 clinical trials that the Moderna mRNA-1273 vaccine is safe and very effective at preventing COVID-19 in adults. This study can help provide critical information about the safety, reactogenicity, and immune responses observed with the vaccine in children and could ultimately allow the vaccine to be approved for children. This is crucial in getting children back to their usual pre-2020 activities,” Anderson says.

Visit ClinicalTrials.gov and visit the KidCOVE website for additional details.

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.