Phase 3 Trial of Moderna/NIH COVID-19 Vaccine Candidate is Launched

A phase 3 clinical trial designed to investigate the efficacy of biotechnology company Moderna's coronavirus disease 2019 (COVID-19) vaccine candidate has been launched, according to a statement from the US National Institutes of Health (NIH). The vaccine, known as mRNA-1273, is being codeveloped by Cambridge, MA-based Moderna and the National Institute of Allergy and Infectious Disease (NIAID).

“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. This scientifically rigorous, randomized, placebo-controlled trial is designed to determine if the vaccine can prevent COVID-19 and for how long such protection may last," said NIAID Director Anthony S Fauci, MD, in the NIH statement.

The trial, which will be conducted at US clinical research sites, is expected to enroll approximately 30,000 adult volunteers who do not have COVID-19. Moderna will supply the investigational vaccine and funding for the trial is provided by the US Biomedical Advanced Research and Development Authority (BARDA).

There will be 89 US clinical research sites involved, 24 of which are part of the NIH Coronavirus Prevention Network (CoVPN). CoVPN is comprised of existing NIAID-supported clinical research networks and will assist with trial logistics. Investigators will use public health data and incidence trajectory modeling to identify sustained high-incidence areas and emerging hot zones, so sites near these locations can be prioritized for enrollment.

Safety, efficacy, mortality prevention

Under investigation will be the safety of mRNA-1273 and whether the vaccine can prevent symptomatic COVID-19 after 2 doses. Secondary outcomes include whether the vaccine can prevent severe COVID-19 or laboratory-confirmed SARS-CoV-2 infection with or without disease symptoms. Efficacy after 1 dose in preventing symptomatic COVID-19 and prevention of infection-related death will also be evaluated.

Volunteers in the double-blind trial will be randomized 1:1 to receive 2 injections of either 100 mcg mRNA-1273 or a saline placebo. A nasopharyngeal swab and blood sample will be collected at initial screening and at specified time points after each vaccination and over the 2 years following the second vaccination. Informed consent is required to participate.

If a SARS-CoV2 infection is suspected, the participant will provide a nasal swab within 72 hours; if the test is positive, appropriate medical follow-up and needed care will be provided.

The vaccine efficacy trial is the first to be implemented under Operation Warp Speed, a multi-agency collaboration led by HHS that aims to accelerate the development, manufacturing and distribution of medical countermeasures for COVID-19.

“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, in the NIH announcement. “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.”

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People 18 years of age and older who are interested in participating in this trial can visit https://www.coronaviruspreventionnetwork.org (link is external)or ClinicalTrials.gov and search identifier NCT04470427 for details.