New York, June 10 : Johnson & Johnson on Wednesday said that it has accelerated the first in-human clinical trial of its investigational SARS-CoV-2 vaccine in the second half of July via its Janssen Pharmaceutical Companies (Janssen).
The trial for the vaccine, Ad26.COV2-S, recombinant, was initially scheduled to begin in September.
“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, Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson.
“Simultaneously, we are continuing our efforts to build important global partnerships and invest in our vaccine production technology and manufacturing capabilities,” he added in a statement.
The randomised, double-blind, placebo-controlled Phase 1/2a study will evaluate the safety, reactogenicity (response to vaccination), and immunogenicity (immune response) of the vaccine in 1,045 healthy adults aged 18 to 55 years, as well as adults aged 65 years and older.
The study will take place in the US and Belgium.
“Our goal is to ensure we can deliver a vaccine to the world and protect people everywhere from this pandemic,” said the company.
Over 100 vaccines are under various stages of trial and according to the scientists, it make take 12-18 months before a successful one is achieved.
The company is in discussions with the National Institutes of Allergy and Infectious Diseases with the objective to start the Phase 3 vaccine clinical trial ahead of its original schedule, pending outcome of Phase 1 studies and approval of regulators.