Pharma giant Johnson & Johnson (J&J) has started a massive global phase 3 clinical trial with 60,000 people of its single-dose coronavirus vaccine. The volunteers will be recruited from the US, South Africa, Argentina, Brazil, Chile, Colombia, Mexico and Peru. "Johnson & Johnson will develop and test its COVID-19 vaccine candidate in accordance with high ethical standards and sound scientific principles," the company said in a statement.
Unlike the vaccine being developed by other major players such as Moderna, Pfizer, BioNTech, AstraZeneca and the University of Oxford, J&J will be initially testing a single dose.
"The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a single vaccine dose versus placebo in up to 60,000 adults 18 years old and older, including significant representation from those that are over age 60," the company said in a statement.
According to a recent study, the vaccine by the pharma major has potential to raise neutralising antibodies that robustly protect hamsters against severe infection with the novel coronavirus. The research, published in the journal Nature Medicine, also demonstrated that the vaccine elicited robust immune response in Syrian golden hamsters, and prevented severe clinical disease including weight loss, pneumonia, and death.
The vaccine, co-developed by the Beth Israel Deaconess Medical Center and Johnson & Johnson (J&J), uses a common cold virus, called adenovirus serotype 26 (Ad26), to deliver the SARS-CoV-2 spike protein into host cells, where it stimulates the body to raise immune responses against the coronavirus.