mRNA-1273 Vaccine Shows Promise in Early Stage Trial for COVID-19

Preliminary results from a phase 1 trial of the investigational mRNA-1273 vaccine, designed to protect against SARS-CoV-2, have shown promising results in healthy adults. The vaccine was generally well-tolerated and prompted neutralizing antibody activity, which is essential for preventing the virus from entering human cells. The trial, supported by the National Institute of Allergy and Infectious Diseases (NIAID), involved 45 participants aged 18 to 55 years who received two intramuscular injections of the vaccine.

Key Takeaways:

  • The mRNA-1273 vaccine was generally well-tolerated, with no serious adverse events reported.
  • More than half of the participants experienced side effects such as fatigue, headache, chills, myalgia, or pain at the injection site.
  • Systemic adverse events were more common following the second vaccination and in those who received the highest vaccine dose.
  • The vaccine prompted high levels of neutralizing antibody activity that were above the average values seen in convalescent sera obtained from persons with confirmed COVID-19 disease.
  • Two doses of the vaccine induced high levels of neutralizing antibody activity, which was above the average values seen in convalescent sera obtained from persons with confirmed COVID-19 disease.
  • The trial's initial findings informed the doses used or planned for use in the phase 2 and 3 clinical trials of the vaccine.
  • Plans are underway to launch a phase 3 efficacy trial in July 2020.
  • Additional information about the phase 1 clinical trial design is available at ClinicalTrials.gov using the identifier NCT04283461.

Statistics:

  • 45 participants aged 18 to 55 years were enrolled in the phase 1 trial.
  • Three groups of 15 participants received two intramuscular injections, 28 days apart, of either 25, 100, or 250 micrograms (mcg) of the investigational vaccine.
  • 42 participants received both scheduled injections.
  • The vaccine prompted high levels of neutralizing antibody activity, with values above the average seen in convalescent sera obtained from persons with confirmed COVID-19 disease.

Sources:

  • LA Jackson et al. A SARS-CoV-2 mRNA vaccine--preliminary report. New England Journal of Medicine DOI: 10.1056/NEJMoa2022483 (2020)
  • NIAID News Release (Note: The original text does not mention a specific publication date, so I did not add a date to the reference)