GeoVax Labs, Inc. announced that it received an award through the Rapid Response Partnership Vehicle (RRPV) to advance development of GEO-CM04S1, GeoVax's dual-antigen next-generation COVID-19 vaccine, in a Phase 2b clinical trial. The RRPV is a Consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Prep preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS). Under the agreement, GeoVax will sponsor a 10,000-participant, randomized, Phase 2b double-blinded study to compare the efficacy, safety, and immunogenicity of GEO-CM04 S1 with a U.S. Food and Drug Administration (FDA)-approved mRNA COVID-19 vaccine.

Preparations for the study are underway, and execution of the study will be fully funded by BARDA under its Clinical Studies Network. The direct award to GeoVax of approximately $24.3 million, which may increase to as much as $45 million, will fund the manufacturing of clinical materials and support for the Phase 2b clinical trial, including regulatory activities. BARDA has made separate awards through its Clinical Studies Network to support execution of the study.