National Institutes of Health launches 4th phase III COVID-19 vaccine study

By The Science Advisory Board staff writers

September 23, 2020 -- A phase III clinical trial evaluating the investigational Janssen COVID-19 vaccine Ad26.COV2.S for the prevention of symptomatic COVID-19 in a single-dose regimen has begun.

The trial is part of Operation Warp Speed (OWS) and is being funded by Johnson & Johnson (a Janssen company); the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH); and the Biomedical Advanced Research and Development Authority (BARDA), a U.S. federal health agency.

The study will enroll up to 60,000 volunteers at nearly 215 clinical research sites in the U.S. and internationally. The trial sites are part of an NIAID-supported COVID-19 Prevention Network.

The Accelerating COVID-19 Therapeutic Interventions and Vaccines public-private partnership will ensure the protocols of all NIH- and OWS-supported phase III trials of investigational vaccines use the same assays and enables transparent evaluation of vaccines across trials.

Johnson & Johnson's vaccine candidate is a recombinant vector vaccine that uses human adenovirus to express the SARS-CoV-2 spike protein in cells. Preclinical data demonstrated that the vaccine induced neutralizing antibody responses in rhesus macaques and provided complete or near-complete protection against the virus in the lungs and nose. Interim results from an ongoing phase I/IIA trial in the U.S. and Belgium indicate that the vaccine has a positive safety profile and immunogenicity after a single vaccination.

J&J to provide U.S. with 100M doses of COVID-19 vaccine
Johnson & Johnson will manufacture and deliver 100 million doses of its SARS-CoV-2 investigational vaccine to the U.S. government once it receives...
J&J reports positive preclinical results for COVID-19 vaccine
Johnson & Johnson reported that its lead COVID-19 vaccine candidate protected against SARS-CoV-2 in preclinical studies.
NIH forms COVID-19 clinical trials network
The National Institute of Allergy and Infectious Diseases, part of the U.S. National Institutes of Health (NIH), has established a new clinical trials...
J&J to start clinical trial for COVID-19 vaccine in July
Johnson & Johnson is accelerating its investigational SARS-CoV-2 vaccine candidate, Ad26.COV2-S, recombinant, with the initiation of a phase I/IIA...
NIH leadership discusses COVID-19 vaccine collaborations
Public-private partnerships could help meet the unprecedented need to manufacture and distribute safe and effective COVID-19 vaccines around the globe,...

Copyright © 2020

Register below for our weekly Letter from the Editor to receive the latest Science news and insights.
Science Advisory Board on LinkedIn
Science Advisory Board on Facebook
Science Advisory Board on Twitter