Recruitment of adult volunteers for a fourth Phase 3 clinical trial evaluating an investigational vaccine against COVID-19 has begun in the United States, the National Institutes of Health (NHS) announced on Wednesday.
The trial, designed to assess whether the investigational Janssen COVID-19 vaccine (JNJ-78436725) can prevent symptomatic COVID-19 after a single-dose regimen, will seek to enroll up to 60,000 volunteers at around 215 clinical research sites, both national and international.
“Having a single vaccine candidate in Phase 3 trials less than a year after a virus was first reported would be a remarkable achievement. Having four candidates at that stage is extraordinary, ”said Secretary of the Department of Health and Human Services (HHS), Alex Azar.
“By creating a portfolio of vaccine candidates, you 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, the director of the National Institute of Allergy and Infectious Diseases (NIAID) and the country’s leading epidemiologist, Anthony S. Fauci, described it as an “unprecedented feat” that there are currently four COVID-19 vaccine candidates that are 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 in government, industry and academia,” he added.
Janssen’s candidate vaccine is a recombinant vector vaccine that uses a human adenovirus to express the SARS-CoV-2 spike protein in cells.