Johnson & Johnson announced Wednesday that its investigational SARS-CoV-2 vaccine — known as Ad26.COV2-S, recombinant — will be fast-tracked to begin its Phase I/2a first-in-human clinical trial in the second half of July. Originally, it was scheduled to start in September.
The study will be held in the United States and Belgium, and it will be randomized, double-blind and placebo-controlled. Phase 1/2a will look at safety, the body's response to the vaccination and the immune response of the vaccine. The study will include 1,045 healthy adults between the ages of 18 and 55, plus adults who are 65 and older.
"Based on the strength of the preclinical data we have seen so far and interactions with the regulatory authorities, we have been able to further accelerate the clinical development of our investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant," said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson, in a press release.
If the vaccine is found to be safe and effective, Johnson & Johnson has committed to the goal of supplying more than one billion vaccine doses globally through the course of 2021.