Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, has accelerated the initiation of the Phase 1/2a first-in-human clinical trial of its investigational COVID-19 vaccine.
The trial is expected to commence in the second half of July, moved up from its initial September time frame.
“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,” Paul Stoffels, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson, said. “Simultaneously, we are continuing our efforts to build important global partnerships and invest in our vaccine production technology and manufacturing capabilities. Our goal is to ensure we can deliver a vaccine to the world and protect people everywhere from this pandemic.”
The Phase 1/2a study will evaluate the safety, reactogenicity (response to vaccination), and immune response of the investigational SARS-CoV-2 vaccine, Ad26.COV2-S, in healthy adults aged 18 to 55 years. The study will take place in the United States and Belgium.
The company is currently in discussions with the National Institutes of Allergy and Infectious Diseases to start the Phase 3 clinical trial ahead of its original schedule, pending the outcome of phase 1 studies and approval of regulators.
As both trials progress, the company continues to work toward the goal of supplying more than one billion doses globally through the course of 2021, provided the vaccine is safe and effective.