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 subjects with a history of HSV-2 recurrent genital herpes.
Genital Herpes Simplex Type 2
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 subjects with a history of HSV-2 recurrent genital herpes.
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
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Alliance for Multispecialty Research, LLC, Tempe, Arizona, United States, 85281
Great Lakes Clinical Trials - Flourish Research, Chicago, Illinois, United States, 60640
Accellacare Raleigh Medical Group, Raleigh, North Carolina, United States, 27609
Accellacare PMG Research Wilmington LLC, Wilmington, North Carolina, United States, 28401
CTI Clinical Research Center, Cincinnati, Ohio, United States, 45212
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to 55 Years
ALL
Yes
BioNTech SE,
BioNTech Responsible Person, STUDY_DIRECTOR, BioNTech SE
2026-10