June 10, 2020 -- Johnson & Johnson is accelerating its investigational SARS-CoV-2 vaccine candidate, Ad26.COV2-S, recombinant, with the initiation of a phase I/IIA clinical trial in late July.
The trial was scheduled to begin in September; however, based on the strength of preclinical data and discussions with regulatory authorities, the company has been able to accelerate the clinical development timeline.
The randomized, double-blind, placebo-controlled phase I/IIA trial will evaluate safety, response to vaccination, and immunogenicity of the vaccine candidate in 1,045 healthy adults 18 to 55 years of age, and in adults over 65 years of age. The study will be conducted in the U.S. and Belgium.
Johnson & Johnson is in discussions with the U.S. National Institute of Allergy and Infectious Diseases about the start date of the phase III clinical trial for the vaccine candidate, pending the positive outcome of phase I studies and proper regulatory approvals.
Meanwhile, Johnson & Johnson continues to ramp up manufacturing capacity in partnership with global collaborators to meet its goal of supplying over 1 billion doses globally by 2021.