Moderna, Inc.’s COVID-19 vaccine candidate mRNA-1273 will advance to a 30,000-participant Phase III trial later this month, following publication of additional positive Phase I data from a study led by the National Institutes of Health (NIH)’s National Institute of Allergy and Infectious Diseases (NIAID).

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Moderna said its closely-watched COVID-19 vaccine candidate mRNA-1273 will advance to a 30,000-participant Phase III trial later this month, following publication of additional positive Phase I data from a study led by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID).

The Phase III “COVE” study (NCT04470427) is expected to begin registration at study centers nationwide beginning on July 21 with study initiation set for six days later. The primary endpoint of the randomized, 1:1 placebo-controlled trial will be the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease as defined by the need for hospitalization, and prevention of infection by SARS-CoV-2, Moderna said.

Moderna disclosed plans for the Phase III trial on Clinicaltrials.gov the same day that researchers from NIAID, Moderna, and their clinical research partners reported that mRNA-1273 induced rapid and strong immune responses against SARS-CoV-2, in an interim analysis of results from their Phase I study (NCT04283461).