GeoVax MVA-X Vaccine Shows Single-Dose Protection Against Mpox, Potentially Simplifying Outbreak Response

GeoVax's next-generation MVA-X vaccine demonstrated durable single-dose protection against lethal mpox, including Clade I, and durable CD8+ T-cell responses in preclinical models, potentially simplifying vaccination campaigns and expanding the MVA platform.

Phoenix Metrowire Staff
••Healthcare
GeoVax MVA-X Vaccine Shows Single-Dose Protection Against Mpox, Potentially Simplifying Outbreak Response

GeoVax Labs, Inc. (Nasdaq: GOVX) announced the publication on bioRxiv of preclinical research demonstrating that a single dose of an enhanced Modified Vaccinia Ankara (MVA) vaccine, designated MVA-X, provided durable protection comparable to a conventional two-dose MVA regimen against multiple orthopoxvirus challenges, including highly pathogenic Clade I mpox virus. The findings, which appear in the manuscript “Single-dose Efficacy of a Next-Generation Mpox Vaccine Harnessing an Immunomodulatory Peptide,” could significantly impact vaccine deployment strategies for mpox and other orthopoxvirus threats.

The research, conducted in collaboration with Washington State University and funded by GeoVax, showed that a single MVA-X vaccination provided complete protection following lethal and high-dose orthopoxvirus challenge at Days 55, 90, and 150 after vaccination. It also restricted viral replication and systemic dissemination, generated durable antigen-specific CD8+ T-cell responses despite declining circulating antibody levels, and protected highly susceptible animals against lethal challenge with highly pathogenic Clade I mpox virus. The manuscript is available as a preprint on bioRxiv (https://www.biorxiv.org/content/10.1101/2026.07.31.742137v1) and has not been peer-reviewed.

MVA has an extensive safety record and is a critical vaccine platform for infectious disease preparedness and biosecurity. Currently, recommended MVA-based vaccination for mpox generally involves a two-dose regimen. The MVA-X construct was designed to explore a single-dose approach through modifications intended to enhance early immune priming while preserving the established attributes of the MVA platform. The results suggest that augmenting early immune responses may achieve durable protection with just one vaccination.

David Dodd, Chairman and CEO of GeoVax, commented, “Two-dose administration has long been an accepted characteristic of MVA vaccination. These results provide encouraging preclinical evidence that it may be possible to achieve durable protection following a single vaccination utilizing MVA-X. The potential significance of such an innovation is considerable. During an outbreak, reducing a two-dose regimen to a single vaccination could simplify deployment, accelerate completion of vaccination programs and reduce the logistical burden associated with protecting at-risk populations.”

Dodd continued, “We also view these findings within a broader effort at GeoVax to expand the utility of MVA as a vaccine platform. We are advancing innovations directed at important considerations in vaccine deployment, including dosing, manufacturing and administration. Our objective is to build upon MVA’s established attributes while developing approaches that could make MVA-based vaccines increasingly practical and deployable for global health, outbreak response and biosecurity.”

Mark Newman, Ph.D., Chief Scientific Officer of GeoVax, added, “These data point toward an innovative approach to augmenting MVA potency and provide support for the important role of the cellular arm of the immune system, particularly CD8-positive T-cell responses, in controlling and clearing orthopoxvirus infection. These findings support further investigation to determine if augmentation of MVA potency can be developed as a next-generation, single-dose vaccine approach for protection against orthopoxvirus infections, with an initial focus on mpox.”

The MVA-X research represents one element of GeoVax’s broader effort to advance the utility of MVA-based vaccines. In parallel, the company is advancing continuous cell-line manufacturing and evaluating needle-free microarray patch delivery. Together, these initiatives address three important considerations in vaccine deployment—dosing, manufacturing, and administration—with the potential to improve operational flexibility, particularly during outbreaks and in global health, resource-constrained, and biosecurity settings.

GeoVax’s priority program is GEO-MVA, an MVA-based vaccine targeting mpox and smallpox, which is advancing under an expedited regulatory pathway with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy designed to enhance immune checkpoint inhibitor activity. For more information, visit www.geovax.com.

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