NCT05432583

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

Phase I, Randomized, Observer-blinded, 3-part, Dose Escalation and Expanded Safety and Dose Evaluation Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Prophylactic Vaccine for the Prevention of Genital Lesions Caused by Herpes Simplex Virus (HSV)-2 and Potentially HSV-1

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 318 (actual)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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, 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.

Detailed description

In Part A, participants will be randomized 5:1 to BNT163:placebo. In Part B, participants will be randomized 1:1 to either of the two selected dose levels based on data from Part A. In Part C, participants will be randomized 1:1 to BNT163:placebo. In Part A \& B, participants will receive three intramuscular doses of a fixed dose level of the BNT163 vaccine (Part A and B) or placebo (Part A only). In Part C, participants will receive three intramuscular doses of one fixed dose level of the BNT163 vaccine or placebo. In this part, continuous suppressive antiviral therapy is given over the entire vaccine dosing period (during and between vaccine doses) to prevent administration of the vaccine concomitantly to viral replication and active genital herpes.

Conditions

• Genital Herpes Simplex Type 2

Interventions

Type	Name	Description
BIOLOGICAL	BNT163	Anti-viral ribonucleic acid (RNA) vaccine for active immunization against HSV-2 administered as intramuscular injection
OTHER	Placebo	Placebo

Timeline

• Start date: 2022-12-08
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2022-06-27
• Last updated: 2025-10-20

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study