Trial Profile

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: Recruiting

Phase of Trial: Phase I

Latest Information Update: 19 Feb 2025

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At a glance

12 Feb 2025 Planned End Date changed from 1 Apr 2026 to 1 Oct 2026.
12 Feb 2025 Planned primary completion date changed from 1 Apr 2026 to 1 Oct 2026.
16 Oct 2024 Arms increased from 4 to 6. New part 'Part C to evaluate safety and immunogenicity of BNT163 compared to a placebo in a two-dose regimen in subjects with a history of HSV-2 recurrent genital herpes' added newly.

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