Johnson & Johnson to Begin Largest, Late-Stage 60,000 Person COVID-19 Vaccine Trial in September

Johnson & Johnson (New Brunswick, NJ, USA) plans to enroll 60,000 volunteers in a Phase 3 trial for its COVID-19 vaccine candidate that is set to begin in September, making it the largest, late-stage trial for testing a potential coronavirus vaccine.

According to the US government’s clinical trial database, the purpose of the study is to demonstrate the efficacy of the company’s potential coronavirus vaccine, Ad26.COV2.S, in the prevention of molecularly confirmed moderate to severe/critical COVID-19, as compared to placebo, in SARS-CoV-2 adult participants. In pre-clinical studies, Johnson & Johnson’s investigational adenovirus serotype 26 (Ad26) vector-based COVID-19 vaccine had elicited a robust immune response as demonstrated by “neutralizing antibodies,” successfully preventing subsequent infection and providing complete or near-complete protection in the lungs from the virus in non-human primates (NHPs).

A J&J spokesman told CNBC that the Phase 3 trial would enroll up to 60,000 healthy people ages 18 and older across nearly 180 locations in the US and other countries. The enrolment is double that of leading vaccine makers Moderna and Pfizer who are also set to conduct their own Phase 3 trials. Pfizer has completed enrolment of more than 11,000 people and Moderna has reportedly signed up 8,374 participants in the first three weeks of its own trial. Additionally, AstraZeneca, which is also conducting the Phase 3 study of its coronavirus vaccine candidate in the UK, Brazil and South Africa, has enrolled about 8,000 participants in the UK, and vaccinated about 3,000 volunteers in Brazil and 900 participants in South Africa. Johnson & Johnson’s Phase 3 trial is expected to start around September 5 in which participants will be randomly selected to receive a dose of the potential vaccine or a placebo to determine its safety and effectiveness. Researchers will follow the participants for more than two years.

“Our Phase 3 program is intended to be as robust as possible, could include up to 60,000 participants and will be conducted in places with high incidence rates,” J&J spokesman Jake Sargent said in a statement to CNBC. “We are using epidemiology and modeling data to predict and plan where our studies should take place and expect that to be finalized soon.”

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