Large-Scale NIH-Sponsored COVID-19 Vaccine Trials Underway

Four large-scale, phase III clinical trials to evaluate vaccines against COVID-19 codeveloped by the National Institutes of Health (NIH) and pharmaceutical companies have launched as part of the NIH’s Coronavirus Prevention Network (CoVPN).

The trial of Moderna’s mRNA-1273 has enrolled 30,000 adult volunteers, making it the largest study of a COVID-19 vaccine so far. Testing is being conducted at approximately 89 clinical research sites in the U.S., 24 of which are part of the CoVPN. Participants are being randomized 1:1 to receive either two intramuscular injections of mRNA-1273 100 µg or two shots of saline placebo, approximately 28 days apart.

AstraZeneca’s AZD1222 is being investigated in a phase III trial that plans to enroll approximately 30,000 adults at 80 sites in the U.S, which was implemented as part of Operation Warp Speed and the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership. The trial’s primary aim is to determine whether AZD1222 can prevent symptomatic COVID-19 after two doses. Participants will be followed for 2 years after their second vaccination.

Janssen’s JNJ-78436735 is being evaluated in the randomized, double-blind phase III ENSEMBLE trial, which plans to enroll up to 60,000 volunteers at more than 200 clinical research sites in the U.S. and internationally. Per trial protocol, JNJ-78436735 can be administered in a single- or two-dose schedule.

The phase III trial of NVX-CoV2373, from Novavax, is being conducted in the U.K., in partnership with the U.K. Government’s Vaccines Taskforce. It is expected to enroll and immunize up to 10,000 adults with COVID-19, with and without relevant comorbidities. Half of participants will receive two intramuscular injections of the vaccine, while half of the trial participants will receive placebo.

“These trials need to be multigenerational, they need to be multiethnic, they need to reflect the diversity of the United States population,” said Larry Corey, MD, President and Director Emeritus of the Fred Hutchinson Cancer Research Institute, who is co-leading CoVPN’s vaccine efforts.

“Four COVID-19 vaccine candidates are in phase III clinical testing in the United States just over 8 months after SARS-CoV-2 was identified. This is an unprecedented feat for the scientific community made possible by decades of progress in vaccine technology and a coordinated, strategic approach across government, industry and academia,” said Anthony S. Fauci, MD, Director of the NIH’s National Institute of Allergy and Infectious Diseases. “It is likely that multiple COVID-19 vaccine regimens will be required to meet the global need.”

Sources: NIH news release, September 23, 2020; AP, July 27, 2020.