The Phase 1 of the Moderna, SARSCoV2 vaccine results published by NEJM and they are very encouraging for immune response and safety in 45 healthy people, 2 shots, increasing doses. The study is funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 ClinicalTrials.gov number, NCT04283461).
This phase 1, dose-escalation, open-label trial including 45 healthy adults, 18 to 55 years of age, who received two vaccinations, 28 days apart, with mRNA-1273 in a dose of 25 μg, 100 μg, or 250 μg. There were 15 participants in each dose group.
As per study results, after the first vaccination, antibody responses were higher with higher dose. After the second vaccination, serum-neutralizing activity was detected by two methods in all participants evaluated, with values generally similar to those in the upper half of the distribution of a panel of control convalescent serum specimens.
Solicited adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Systemic adverse events were more common after the second vaccination, particularly with the highest dose, and three participants (21%) in the 250-μg dose group reported one or more severe adverse events. One participant in the 25-μg group was withdrawn because of an unsolicited adverse event, transient urticaria, judged to be related to the first vaccination.
From the results published in article, the increased proportion of systemic AEFI (adverse event following immunization), including moderate events, on second dose is notable, especially given that post-vaccine exposure to circulating virus is highly probable.
Link for article: https://www.nejm.org/doi/full/10.1056/NEJMoa2022483?query=featured_home
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