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ACTIVE NOT RECRUITING
NCT05432583
PHASE1

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

Sponsor: BioNTech SE

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

318

Start Date

2022-12-08

Completion Date

2026-10

Last Updated

2025-10-20

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

BNT163

Anti-viral ribonucleic acid (RNA) vaccine for active immunization against HSV-2 administered as intramuscular injection

OTHER

Placebo

Placebo

Locations (6)

Alliance for Multispecialty Research, LLC

Tempe, Arizona, United States

Great Lakes Clinical Trials - Flourish Research

Chicago, Illinois, United States

Accellacare Raleigh Medical Group

Raleigh, North Carolina, United States

Accellacare PMG Research Wilmington LLC

Wilmington, North Carolina, United States

CTI Clinical Research Center

Cincinnati, Ohio, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States