A Clinical Trial in Healthy Volunteers and Volunteers With Recurrent Genital Herpes to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions
Running, not enrolling · Phase 1 · Has a placebo group
Conditions studied: Genital Herpes Simplex Type 2
In brief
This exploratory trial will have three parts. Part A is a dose escalation part, Part B is an expanded safety and dose evaluation part, and Part C is a safety and immunogenicity evaluation part in individuals with recurrent HSV-2 genital herpes. Part A will focus on the safety evaluations, and in addition, vaccine-induced immune responses (specifically neutralizing antibodies) will also be analyzed to assess if there is a dose-response. Part B of the trial will expand the safety characterization for two dose levels of BNT163 selected based on Part A data and will also enable a more comprehensive assessment of the impact of pre-existing immunity to HSV-1 and -2 on the safety and immune responses to BNT163. Part C will evaluate safety and immunogenicity of BNT163 compared to a placebo in a three-dose regimen in participants with a history of HSV-2 recurrent genital herpes.
Key facts
- Study ID
- NCT05432583
- Run by
- BioNTech SE
- People needed
- 318
- Starts
- 2022-12-08
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2025-10-20
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
Where it is running
- Alliance for Multispecialty Research, LLC — Tempe, Arizona, United States
- Great Lakes Clinical Trials - Flourish Research — Chicago, Illinois, United States
- Accellacare Raleigh Medical Group — Raleigh, North Carolina, United States
- Accellacare PMG Research Wilmington LLC — Wilmington, North Carolina, United States
- CTI Clinical Research Center — Cincinnati, Ohio, United States
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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