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Safety and Immunogenicity of BNT163, a Trivalent mRNA HSV Vaccine Candidate for Genital Herpes

Open Forum Infectious Diseases (IDWeek 2025) · 2025 Open access

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PMCID: PMC12793109

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A conference abstract (IDWeek 2025) reporting early safety and immune-response data from the first-in-human Phase 1 trial of BioNTech's trivalent mRNA candidate BNT163. As a Phase 1 report it addresses safety and immunogenicity, not whether the vaccine prevents genital herpes, and as a conference abstract it has not undergone full peer-reviewed publication.

This IDWeek 2025 abstract is the first public read-out of immune-response and safety data from the Phase 1 trial (NCT05432583) of BNT163, BioNTech’s trivalent mRNA candidate — the clinical form of the University of Pennsylvania trivalent approach.

Two cautions on how to read it. First, a Phase 1 study is designed to gauge safety and whether the vaccine provokes an immune response; it is not powered to show that the vaccine prevents infection or lesions. Second, this is a conference abstract, not a peer-reviewed paper — the full data and analysis are not yet published. We list it because it is the primary, dated record of where the program stands, and we will update the candidate page if a peer-reviewed publication follows.

Sources

  1. Safety and Immunogenicity of BNT163, a Trivalent mRNA HSV Vaccine Candidate for Genital Herpes (abstract P-105) — Open Forum Infectious Diseases (IDWeek 2025) , 2025