NIH-Sponsored COVID-19 Vaccine Trials Launch with 30,000 Volunteers

Phase III clinical trials to evaluate mRNA-1273, an investigational vaccine against COVID-19 developed by the National Institutes of Health (NIH) and drug developer Moderna, have enrolled 30,000 adult volunteers. It is the largest study of a COVID-19 vaccine so far, and the vaccine is one of several candidates being studied worldwide.

Testing will be conducted at approximately 89 clinical research sites in the U.S., 24 of which are part of the NIH’s Coronavirus Prevention Network (CoVPN). Participants will be randomized 1:1 to receive either two intramuscular injections of mRNA-1273 100 mcg or two shots of saline placebo, approximately 28 days apart.

The randomized, double-blind trials are designed to evaluate vaccine safety and to determine whether treatment with mRNA-1273 can prevent symptomatic COVID-19 after two doses. Secondary goals include assessing if the vaccine can prevent severe COVID-19 and laboratory-confirmed SARS-CoV-2 infection with or without symptoms. Researchers also will examine whether the vaccine can prevent death caused by COVID-19 and whether a single dose can prevent symptomatic infection.

This is the first in a series of similar testing phases that will be carried out by CoVPN. The network plans to roll out a new study of a leading vaccine candidate every month through the fall, each with 30,000 volunteers. The phase III U.S. study of the vaccine developed by Oxford University will begin in August, followed by plans to test candidates from Johnson & Johnson and Novavax in September and October, respectively.

“These trials need to be multigenerational, they need to be multiethnic, they need to reflect the diversity of the United States population,” said Larry Corey, MD, President and Director Emeritus of the Fred Hutchinson Cancer Research Institute, who is co-leading CoVPN’s vaccine efforts.

Sources: AP, July 27, 2020; NIH news release, July 27, 2020.