Moderna and the National Institutes of Allergy and Infectious Diseases have initiated a phase 3 trial evaluating the vaccine candidate mRNA-1273 against coronavirus disease 2019 (COVID-19).
The trial, which is the first to be implemented under Operation Warp Speed, is expected to enroll around 30,000 adults and will be conducted at multiple clinical research sites across the US. In addition, the National Institutes of Health (NIH) Coronavirus Prevention Network will participate in conducting the trial. Testing sites in areas with emerging cases or high incidence rates will be prioritized for enrollment.
Participants will be randomized to receive 2 intramuscular injections of either mRNA-1273 or saline placebo approximately 28 days apart. The study’s primary aim will be to assess whether the vaccine is able to prevent symptomatic COVID-19 after the administration of 2 doses; prevention after 1 dose will also be investigated as a secondary goal. Moreover, researchers will look at whether vaccination with mRNA-1273 prevents severe COVID-19 or laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection with or without disease symptoms, as well as death.
“Results from early-stage clinical testing indicate the investigational mRNA-1273 vaccine is safe and immunogenic, supporting the initiation of a phase 3 clinical trial,” said NIAID Director Anthony S. Fauci, MD.
At the initial screening, participants will provide a nasopharyngeal swab and a blood sample. They will then be followed at specified time points after each vaccination and for 2 years following the last dose; additional blood samples will be taken throughout the study period. Participants will be asked to keep a diary to record symptoms and to do temperature checks.
If COVID-19 is suspected, a study participant will be asked to provide a nasal swab for testing. If positive, the participant will be followed closely and will be asked to provide daily assessment of symptoms until resolution, in addition to providing saliva samples for SARS-CoV-2 testing.
As for safety, an independent data and safety monitoring board will review data at scheduled meetings.
“Having a safe and effective vaccine distributed by the end of 2020 is a stretch goal, but it’s the right goal for the American people,” said NIH Director Francis S. Collins, MD, PhD. “The launch of this phase 3 trial in record time while maintaining the most stringent safety measures demonstrates American ingenuity at its best and what can be done when stakeholders come together with unassailable objectivity toward a common goal.”
For more information visit nih.gov.