BARDA provides $24 million under Project NextGen for clinical trial of novel COVID-19 vaccine candidate that may provide broader, longer protection

The 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, will provide approximately $24 million in Project NextGen funding to GeoVax, Inc. of Atlanta, Georgia, for a phase 2b clinical trial with the company’s COVID-19 vaccine candidate GEO-CM04S1. The award was made through BARDA’s Rapid Response Partnership Vehicle.

The BARDA-funded clinical trial will evaluate the safety and efficacy of GeoVax’s vaccine candidate compared to licensed vaccines. Currently licensed COVID-19 vaccines target the spike protein of the virus. This investigational vaccine targets spike as well as non-spike proteins of the virus which might provide broader and more durable protection against new variants of the SARS-CoV-2 virus.

GeoVax will work with BARDA’s clinical studies network to conduct the clinical trial with up to 10,000 volunteers. Established in 2012 as a core service, BARDA’s clinical studies network provides comprehensive (Phase 1-4) clinical study services to evaluate the safety, dosage, pharmacokinetics, pharmacodynamics, and efficacy of medical countermeasure candidates such as vaccines and treatments.

Project NextGen is a $5 billion program led by BARDA and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to accelerate and streamline the development of the next generation of innovative COVID-19 vaccines, therapeutics, and enablers. This is the fourth award made through the Rapid Response Partnership Vehicle to support Phase 2b clinical trials of novel COVID-19 vaccines. To date, BARDA has leveraged more than $2 billion in Project NextGen funding to support development of next generation vaccines, treatments, and enabling technologies.

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