In the phase I study, patients were dosed at 25 µg or 100 µg; all participants seroconverted by day 15 after a single dose. Researchers found that mRNA-1273 vaccination-neutralizing antibody titers in eight patients exceeded those seen in convalescent sera. Moreover, the vaccine was generally safe and well-tolerated by participants.
In the phase II study, the company will amend the dose levels, at 50 µg and 100 µg, with the goal of selecting a pivotal dose. The NIAID-led phase I study is also amending doses to include a 50 µg dose level cohort across three age groups.
Phase II and III studies of mRNA-1273 are supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA). They are also supporting the scale-up of mRNA-1273 manufacturing at two Moderna facilities as well as at Lonza facilities, a strategic partner of the company.
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