ICON, a healthcare intelligence and clinical research organisation, with the US Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the US Department of Health and Human Services, will execute a clinical trial to evaluate the effectiveness of next-generation Covid-19 vaccine candidates.
Next generation Covid-19 vaccines could have the potential to expand the breadth of coverage against existing and future variants of the virus, extend the duration of protection, and offer better protection in the prevention of illness and transmission over the current state of vaccine technologies.
Against this backdrop, the Government & Public Health Solutions team at ICON will execute a Phase IIb clinical trial to assess the relative efficacy of a next generation Covid-19 vaccine compared to currently approved/authorised Covid-19 vaccines in the prevention of symptomatic, PCR confirmed SARS-CoV-2 infection.
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 IIb clinical trial to support in benchmarking its efficacy against existing vaccines.
This trial is part of Project NextGen, which coordinates across the US government and the private sector to advance innovative vaccines and therapeutics into clinical trials, regulatory review, and potential commercial availability.
Edward Wright, President, ICON Government & Public Health Solutions, commented: “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 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.”