ICON plc, a healthcare intelligence and clinical research organisation, is partnering with the U.S. Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, to 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 2b 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 2b clinical trial to support in benchmarking its efficacy against existing vaccines.
ICON has extensive experience in vaccine clinical development for commercial businesses, governments and NGOs, having participated in over 184 vaccine studies in the past five years. This experience has already helped ICON play a significant role in the search for vaccines and treatments for COVID-19. The company has partnered with its customers on the development of a number of approved vaccines. ICON has conducted or is currently involved in over 86 COVID-19 related trials.
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.”
In addition to its Government & Public Health Solutions team, ICON draws on the expertise of its biotech division, which comprises over 8,000 staff dedicated to biotech customers. As the world’s largest dedicated biotech division, the team works with over 500 biotech sponsors annually.
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.”
This 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.
BARDA is responsible for developing medical countermeasures to secure the U.S. against chemical, biological, radiological, and nuclear threats, as well as pandemic influenza and emerging infectious diseases.
Since 2014, ICON has been a member of BARDA’s Medical Countermeasures Clinical Studies Network (CSN). The network supports planning and implementation of clinical studies for medical countermeasure development. ICON has worked on numerous clinical trials as part of this network, including, most recently, the execution of an anthrax vaccine clinical trial.
This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50120D00017.