- Moderna (MRNA -1.1%) is set to begin its first human study for the COVID-19 vaccine candidate targeting a new coronavirus strain as early as next week, The Wall Street Journal reports.
- According to the details posted on the federal database of clinical trials, the Phase 1 open-label, randomized clinical trial will evaluate the experimental variant vaccine, mRNA-1273.351 alone or in combination with the mRNA-1273 vaccine that is already approved in the U.S.
- The trial will be conducted in five U.S. research sites. Cohort one involving 60 subjects aged 18 years and older will include those who received two vaccinations of mRNA-1273. They will be followed up for 12 weeks after a single intramuscular ("IM") injection with mRNA-1273.351.
- The second cohort involving 150 healthy individuals aged 18 - 55 years will be those who did not receive any COVID-19 vaccine and had no history of COVID-19 infection.
- Assigned to one of six treatment arms, each will receive 2 or 3 intramuscular injections of the vaccine and will be followed through 12 months after the last vaccination.
- The primary objective of the trial is to assess the safety and efficacy of mRNA-1273 and mRNA-1273.351 vaccines and the secondary objective is to assess the antibody-mediated immunity of mRNA-1273 and mRNA-1273.351 vaccines.
- In February, Moderna announced it has completed the manufacturing of clinical trial material for a variant-specific vaccine candidate targeting the strain first detected in South Africa.