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

Genital Herpes Simplex Type 2 Clinical Trial

Official title: Phase I, Randomized, Observer-blinded, Placebo-controlled, 2-part, Dose Escalation and Expanded Safety 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 Recruiting

Clinical Trial Summary

This exploratory trial will have two parts. Part A is a dose escalation part and Part B is an expanded safety and dose evaluation part. 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.

Clinical Trial 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. Participants will receive three intramuscular doses of a fixed dose level of the BNT163 vaccine (Part A and B) or placebo (Part A only). ;

Related Conditions & MeSH terms

• Genital Herpes Simplex Type 2
• Herpes Genitalis
• Herpes Simplex

• NCT number: NCT05432583
• Study type: Interventional
• Source: BioNTech SE
• Contact: BioNTech clinical trials patient information
• Phone: +49 6131 9084
• Email: patients@biontech.de
• Status: Recruiting
• Phase: Phase 1
• Start date: December 8, 2022
• Completion date: December 2025