A Clinical Trial in Healthy Volunteers to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions

Protocol summary

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, but 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 also enable a more comprehensive assessment of the impact of pre-existing immunity to Herpes Simplex Virus (HSV)-1 and -2 on the safety and BNT163-induced immune responses than could be assessed in Part A. Part C will evaluate safety and immunogenicity of BNT163 compared to a placebo in a two-dose regimen in subjects with a history of HSV-2 recurrent genital herpes.