Johnson & Johnson (J&J) has expedited the launch of a Phase I/IIa clinical trial of its Covid-19 vaccine candidate, Ad26.COV2-S, from September this year to the second half of next month.
The randomised, double-blind, placebo-controlled trial will assess the safety, reactogenicity and immunogenicity of the investigational vaccine recombinant in 1,045 healthy volunteers aged 18 to 55 years, and 65 years and above.
J&J, through its subsidiary Janssen Pharmaceutical, will perform the trial in the US and Belgium.
The company is also in talks with the National Institutes of Allergy and Infectious Diseases to potentially start the Phase III trial of the vaccine ahead of its original schedule, contingent on data from Phase I trials and regulatory approvals.
Johnson & Johnson executive committee vice-chairman and chief scientific officer Paul Stoffels said: “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.
“Our goal is to ensure we can deliver a vaccine to the world and protect people everywhere from this pandemic.”
The company is also working to form global partnerships and invest in vaccine production technology and manufacturing capabilities. The aim is to boost manufacturing capacity and facilitate global access.
J&J expects to supply more than one billion doses of the Covid-19 vaccine worldwide through the course of next year, if the vaccine is found to be safe and effective.
Last month, J&J signed a deal with contract development and manufacturing organisation (CDMO) Vibalogics for the manufacture of clinical trial material for its Covid-19 vaccine candidate.
Under the contract, Vibalogics agreed to produce multiple batches of the vaccine candidate at its facility in Cuxhaven, Germany, expected to yield thousands of vaccine doses.
The vaccine development and production efforts are supported by Janssen’s partnership with the US Biomedical Advanced Research and Development Authority (BARDA).