The Pittsburgh Vaccine Trials Unit is now enrolling children in the “KidCOVE” Moderna vaccine trial!
The PVTU, working with UPMC Children’s Hospital of Pittsburgh, is one of 100 study sites in the U.S. and Canada participating in the study, which seeks to enroll 7,050 children. It is being conducted 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, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
The trial is a Phase 2/3 study of the mRNA-1273 vaccine, which is the Moderna COVID-19 vaccine that the U.S. Food and Drug Administration in December granted an emergency use authorization for people age 18 and older. This two-part trial evaluates the safety, tolerability, reactogenicity and efficacy of the vaccine.
In part one, older participants may receive one of two dose levels and participants six months to 2 years of age may receive one of three dose levels. Each child will receive a second “booster” dose 28 days later.
In part two, an interim analysis will determine which dose will be used in comparison to a placebo. Children will be given either two doses of vaccine 28 days apart or two doses of a saline placebo 28 days apart in a 3:1 ratio, meaning of every four children, three will receive vaccine and one will receive placebo. The children, their parents and their pediatricians will not know whether they received vaccine or placebo.
Participants will receive 12 months of follow-up after the second vaccination to determine its effectiveness in protecting against COVID-19.