Pittsburgh kids can make history by participating in Moderna KidCOVE vaccine trial

By Pittwire

The Pittsburgh Vaccine Trials Unit (PVTU) has joined the pediatric COVID-19 Moderna KidCOVE vaccine trial and is enrolling children ages 6 months to 12 years.

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.

“Last year, Pittsburghers rolled up their sleeves and volunteered to participate in our local Moderna vaccine adult trials, helping to make this vaccine available to the public in record time,” said Judy Martin, primary investigator of the PVTU research registry, professor of pediatrics at the University of Pittsburgh School of Medicine and member of Pitt’s Center for Vaccine Research. “We are excited to now have the opportunity to invite our children to volunteer as well.”

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 ages 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 6 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.

The study 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.

For more information, visit the KidCOVE website. To register for potential participation in the Pittsburgh site of the trial, visit the Pittsburgh Vaccine Trials Unit website.

Pittwire is a publication of the University of Pittsburgh Office of University Communications.