GeoVax Reports Single-Dose MVA-X Vaccine Matches Two-Dose Efficacy in Preclinical Study
GeoVax’s novel MVA-X mpox vaccine achieved protective efficacy equivalent to the standard two-dose regimen in murine models at days 55, 90 and 150. The company plans a pivotal Phase 3 immune bridging study in H2 2026 under a defined regulatory pathway to support single-dose deployment.
1. Preclinical Efficacy Data
GeoVax presented preclinical data showing its MVA-X construct achieved comparable protective efficacy to a traditional two-dose MVA regimen in murine orthopoxvirus challenge models evaluated at days 55, 90 and 150. The immunomodulatory peptide sequence enhanced T cell responses and viral clearance metrics, demonstrating a clear biological signal for single-dose protection.
2. Phase 3 Immune Bridging Study Plans
The company has defined a regulatory pathway and is preparing to launch a pivotal Phase 3 immune bridging study in the second half of 2026. This trial will assess immunogenicity and safety endpoints to support licensure for single-dose administration in humans.
3. Strategic Implications for Global Deployment
A successful single-dose MVA vaccine could streamline outbreak response, improve compliance and extend supply in resource-limited settings. The platform’s flexibility underpins GeoVax’s broader GEO-MVA program, positioning the company to address recurrent mpox threats and bolster biodefense preparedness.