ICON plc., a healthcare intelligence and clinical research organization, is partnering with the U.S. Biomedical Advanced Research and Development Authority (BARDA), to execute a clinical trial to evaluate the effectiveness of next generation COVID-19 vaccine candidates.

The trial is part of Project NextGen, which coordinates across the U.S. Government and the private sector to advance innovative vaccines and therapeutics into clinical trials, regulatory review, and potential commercial availability.

The trial will involve 10,000 subjects, expected to be enrolled over a six-month period. BARDA will select the vaccine candidate to be investigated in this trial, thereby accelerating the start of the Phase 2b clinical trial to support in benchmarking its efficacy against existing vaccines.

ICON will execute a Phase 2b clinical trial to assess the relative efficacy of a next generation COVID-19 vaccine compared to currently approved/authorized COVID-19 vaccines in the prevention of symptomatic, PCR confirmed SARS-CoV-2 infection.

Edward Wright, president, ICON government & public health solutions, said, “We are pleased to be partnering with BARDA on this research at an important juncture in the fight against COVID-19. As new variants emerge, timely clinical research has a pivotal role to play in helping ensure the development of medicines is accelerating as quickly as possible in line with the virus. Our experience in executing COVID-19 trials effectively, efficiently and thoroughly means we are well placed to support those sponsors who are at the scientific forefront in this area.”

Chris Smyth, President, ICON Biotech Solutions said, “In addition to our vaccine clinical development experience, we understand the important role biotech companies have in innovative drug development, and the specific requirements they have as they look to develop their portfolios. We are pleased to have the opportunity to work with them on this trial.”