J&J to Start Largest Phase 3 Vaccine Trial Yet in September

Johnson & Johnson (J&J) expects to begin the largest late-stage trial for a COVID-19 vaccine candidate to date early next month if results from its early-stage studies pan out.

J&J looks to enroll an estimated 60,000 participants in areas with high COVID-19 activity in a phase 3 placebo study to evaluate the safety and efficacy of its experimental vaccine, Ad26.COV2.S.

According to ClinicalTrials.gov, J&J’s phase 3 trial is expected to get under way on Sept. 5 and to involve 178 study sites, though that could change as planning continues.

By comparison, Moderna and Pfizer/BioNTech are enrolling around 30,000 participants in their  phase 3 trials that began in July.

“We can confirm that planning and recruitment is under way for our phase 3 program, which is subject to interim data of the phase 1/2a trials and approval of regulators,” a J&J spokesperson told FDAnews. “We are using epidemiology and modeling data to predict and plan where our studies should take place and expect that to be finalized soon.”

J&J’s candidate has only recently entered human trials in the U.S. and Belgium, placing it behind other hopefuls in the race to develop a COVID-19 vaccine (DID, July 31).

The company is also collaborating with the UK government on an international phase 3 study to evaluate a two-dose regimen of Ad26.COV2.S. The UK will purchase 30 million doses of the vaccine and it has an option to buy 22 million more (DID, Aug. 17). — James Miessler