The first Phase 3 clinical trial of a coronavirus vaccine in the United States began Monday. The investigational vaccine was developed by the biotechnology company Moderna and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
The trial is to be conducted at nearly 100 US research sites, according to Moderna. The first patient was dosed at a site in Savannah, Georgia.
The trial is expected to enroll about 30,000 adult volunteers and evaluates the safety of the Moderna/NIH vaccine and whether it can prevent symptomatic Covid-19 after two doses, among other outcomes. Volunteers will receive either two 100 microgram injections of the vaccine or a placebo about 28 days apart.
The New York Times reports:
Neither the volunteers nor the medical staff giving the injections will know who is getting the real vaccine. Researchers will then monitor the subjects, looking for side effects and waiting to see if significantly fewer vaccinated people get Covid-19, indicating that the vaccine works. T
he main goal is to determine whether the vaccine can prevent the illness. The study will also try to find out if it can prevent severe Covid-19 and death; if it can prevent infection entirely, based on lab tests; and if just one shot can prevent the illness.
Earlier tests of the vaccine showed that it stimulated a strong immune response, with minor and transient side effects like sore arms, fatigue, achiness and fever. But exactly what type of immune response is needed to prevent the illness is not known, so phase 3 studies are essential to determine whether a vaccine really works.