Recruitment of adult volunteers for a fourth Phase 3 clinical trial evaluating an investigational vaccine against COVID-19 has already begun in the United States, the National Institutes of Health (NHS) announced Wednesday.

The trial, designed to evaluate whether the Janssen COVID-19 investigational vaccine (JNJ-78436725) can prevent symptomatic COVID-19 after a single-dose regimen, will seek to enroll up to 60,000 volunteers at about 215 clinical research sites, both domestic and international.

“Having a single vaccine candidate in Phase 3 trials less than a year after a virus is first reported would be a remarkable achievement. To have four candidates at that stage is extraordinary,” said Department of Health and Human Services (HHS) Secretary Alex Azar.

“By creating a portfolio of candidate vaccines, we maximize the chances that we will have substantial supplies of a safe and effective vaccine, and perhaps multiple vaccine options, by January 2021,” he added.

For his part, National Institute of Allergy and Infectious Diseases (NIAID) director and the nation’s leading epidemiologist, Anthony S. Fauci, called it an “unprecedented feat” that there are now four COVID-19 vaccine candidates in Phase 3 clinical trials “just over eight months after SARS-CoV-2 was identified.

This “has been made possible by decades of progress in vaccine technology and a coordinated strategic approach across government, industry and academia,” he added.
Janssen’s vaccine candidate is a recombinant vector vaccine that uses a human adenovirus to express the SARS-CoV-2 peak protein in cells.

Adenoviruses are a group of viruses that cause the common cold; however, the adenovirus vector used in the candidate vaccine has been modified so that it can no longer replicate in humans and cause disease.

Janssen uses the same vector in the first dose of its primary Ebola virus disease booster vaccine regimen that recently received marketing authorization from the European Commission.

Johnson & Johnson’s Janssen pharmaceutical companies developed the investigational vaccine and are leading the clinical trial as a regulatory sponsor. Janssen, NIAID and the Biomedical Advanced Research and Development Authority (BARDA) and the HHS Office of the Assistant Secretary are funding the trial.

The Phase 3 trial is being conducted in collaboration with Operation Warp Speed (OWS), a multi-agency partnership overseen by HHS and the Department of Defense that aims to accelerate the development, manufacture and distribution of medical measures for COVID-19.

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