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.
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Frequency of solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after each dose
Timeframe: Up to 7 days after each dose
Frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue/tiredness, myalgia, arthralgia, chills, and fever) recorded up to 7 days after each dose
Timeframe: Up to 7 days after each dose
Percentage of participants with at least one unsolicited adverse event (AE) occurring up to 28 days after each dose
Timeframe: From Day 1 up to Day 197
Percentage of participants in each cohort with at least one serious AE, or AE of special interest, or medically attended AE occurring up to 24 weeks post-Dose 3 (Parts A & B) or post-Dose 2 (Part C)
Timeframe: From Day 1 up to Day 337
Number of unsolicited AEs occurring up to 28 days after each dose
Timeframe: From Day 1 up to Day 197
Percentage of unsolicited AEs occurring up to 28 days after each dose
Timeframe: From Day 1 up to Day 197