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.

Copyright © 2020
To access all The ScienceBoard content create a free account now:

Email Address:  

First Name:

Last Name:

Learn about ScienceBoard

Get the latest life sciences research and industry news, delivered straight to your inbox, for free.

Why subscribe?

ScienceBoard is uniquely focused on the business of research, addressing the biggest problems that the biomedical industry face. You’ll get breaking news, events coverage, and deep dives into the science that drives innovation, delivered to your inbox daily.

Letter from the Editor Please send me twice-weekly roundups of all the latest life research and industry news.
SAB Announcements Please send me the latest announcements from The Science Advisory Board and their partners.
Spotlight Receive notifications about new content, services, or educational resources designed to help you sharpen your skills and grow professionally.
I have read and agree to the privacy policy and terms of service and wish to opt-in for

Already have an account? Sign in here