Washington, July 28: Pharmaceutical company Moderna has begun a phase-3 clinical trial to evaluate an investigational vaccine known as mRNA-1273 designed to protect against Covid-19 virus.
The trial, which will be conducted at the US clinical research sites, will include 30,000 participants who do not have COVID-19.
“Results from early-stage clinical testing indicate the investigational mRNA-1273 vaccine is safe and immunogenic, supporting the initiation of Phase 3 clinical trial,” said Anthony S. Fauci from National Institute of Allergy and Infectious Diseases (NIAID) in the US.
“This scientifically rigorous, randomised, placebo-controlled trial is designed to determine if the vaccine can prevent COVID-19 and for how long such protection may last,” Fauci added.
The mRNA-1273 is designed to induce neutralising antibodies directed at a portion of the coronavirus “spike” protein, which the virus uses to bind to and enter human cells.
Moderna’s vaccine was co-developed by the Cambridge University and the NIAID, part of the National Institutes of Health (NIH).
According to the researchers, the mRNA-1273 vaccine candidate will be tested at approximately 89 clinical research sites in the US, 24 of which are part of the NIH Coronavirus Prevention Network (CoVPN).
Investigators will use public health data and incidence trajectory modelling to identify sustained high-incidence areas and emerging hot zones, so sites near these locations can be prioritised for enrollment.
The Phase-3 blinded trial will evaluate the safety of mRNA-1273 and determine if the vaccine can prevent symptomatic COVID-19 after two doses.