GeoVax Reports Positive Interim COVID-19 Vaccine Results for Immunocompromised Patients
TL;DR
GeoVax's GEO-CM04S1 vaccine provides competitive advantage by offering broader, more durable COVID-19 protection than mRNA vaccines for immunocompromised patients.
GEO-CM04S1 uses GeoVax's MVA vector platform to co-express spike and nucleocapsid antigens, inducing both antibody and T-cell responses for comprehensive immunity.
This vaccine addresses critical healthcare gaps for vulnerable populations, potentially reducing severe COVID-19 cases and improving protection for immunocompromised individuals worldwide.
GeoVax's novel vaccine generates strong T-cell responses against multiple COVID-19 variants while maintaining a safety profile comparable to established mRNA vaccines.
GeoVax Labs, Inc. presented compelling interim results from its Phase 2 clinical trials for GEO-CM04S1, a multi-antigen COVID-19 vaccine candidate, at the World Vaccine Congress Europe 2025. The data revealed promising safety profiles and robust immune responses in immunocompromised patient populations, including those with hematologic malignancies receiving cellular therapies.
Chief Scientific Officer Mark J. Newman, PhD, highlighted during his workshop presentation that current "one-size-fits-all" vaccines show limitations for immunocompromised populations. The Phase 2 data demonstrated that GEO-CM04S1 elicits strong T-cell responses to both Spike (S) and Nucleocapsid (N) antigens, exceeding responses induced by mRNA boosters. The vaccine candidate showed broad, durable immunity in preclinical and early clinical data, including responses against Omicron subvariants, suggesting potential for longer-lasting protection and reduced need for frequent vaccine reformulations.
Chief Medical Officer Kelly T. McKee, Jr., MD, MPH presented interim safety results from a Phase 2 trial in patients with hematologic malignancies post-hematopoietic stem cell transplant or chimeric antigen receptor (CAR)-T cell therapy. GEO-CM04S1 demonstrated a safety profile comparable to mRNA vaccines, with only mild-to-moderate treatment-emergent adverse events predominantly consisting of injection site reactions, fatigue, and myalgia. Importantly, no vaccine-related serious adverse events, myocarditis, or pericarditis have been reported to date. Breakthrough infections occurred but were mild-to-moderate in severity.
David Dodd, Chairman & CEO of GeoVax, emphasized the significance of these findings, stating that GEO-CM04S1 has the potential to fill a critical gap for immunocompromised patients who are not adequately protected against severe COVID-19 by existing vaccines. The company's MVA-based, multi-antigen approach is designed to provide broader, more durable protection, with consistent safety profiles emerging across ongoing trials.
GEO-CM04S1 represents a synthetic, next-generation COVID-19 vaccine candidate that co-expresses spike and nucleocapsid antigens using GeoVax's MVA vector platform. This design aims to induce both antibody and T-cell responses, potentially offering more comprehensive protection. The vaccine is currently being evaluated in three Phase 2 clinical trials: as a primary vaccine for immunocompromised individuals including post-transplant and hematologic cancer patients, as a booster for patients with chronic lymphocytic leukemia, and as a durable booster for healthy adults previously immunized with mRNA vaccines.
The implications of these findings extend beyond the immediate patient populations. If successful, GEO-CM04S1 could transform COVID-19 vaccination strategies for vulnerable groups who have remained at elevated risk despite widespread vaccination efforts. The demonstrated safety profile in high-risk populations and the robust T-cell responses suggest potential for reducing hospitalizations and severe outcomes in those most susceptible to COVID-19 complications. For more information about GeoVax's clinical programs and technology platform, visit https://www.geovax.com.
Curated from NewMediaWire