Medical device company Johnson & Johnson moves ahead with a Phase 3 trial of a single-shot dose to treat the virus causing COVID-19.
The company announced on Wednesday “the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate … being developed by its Janssen Pharmaceutical Companies.”
Johnson & Johnson will be the first to test the simpler regimen of its candidate, said Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, to Fox Business.
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A New Vaccine Candidate
Fox Business also reported that this will be the fourth phase three study of a coronavirus candidate in the United States. It follows Moderna, Pfizer, and AstraZeneca. However, J&J currently leads the pack with innovative dosing.
“The initiation of the ENSEMBLE trial follows positive interim results from the Company’s Phase 1/2a clinical study,” the company said in a statement. It “demonstrated that the safety profile and immunogenicity after a single vaccination were supportive of further development.”
In a July statement, Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson, said pre-clinical data “show our SARS-CoV-2 vaccine candidate generated a strong antibody response and provided protection with a single dose.”
“The findings give us confidence as we progress our vaccine development and upscale manufacturing in parallel, having initiated a Phase 1/2a trial in July with the intention to move into a Phase 3 trial in September,” Stoffels also said in July.
According to Barouch, the trial will start in the U.S. and then “rapidly incorporate” other countries. The company aims to enroll participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, and South Africa.