A Phase I open-label study of mRNA-1273 is being conducted by the US National Institutes of Health (NIH). It has completed enrolment of the original study: 45 healthy adult volunteers ages 18 to 55 years in three dose cohorts (25µg, 100µg and 250µg). The NIH recently amended the Phase I protocol to include an additional six cohorts: three cohorts of older adults (ages 56 -70) and three cohorts of elderly adults (age 71 and above). Enrolment of the later cohorts is still ongoing.
Dependent on the safety data from the Phase I study, the company will begin a Phase II study of mRNA-1273 under an Investigational New Drug (IND) application in the second quarter of 2020. The enterprise stated that subject to the data from these studies and discussions with regulators, a Phase III trial could begin in autumn 2020.
BARDA funding will support these late-stage clinical development programmes, as well as the scale-up of mRNA-1273 manufacture to enable the company to meet the demand of a pandemic response.