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
Public ClinicalTrials.gov record NCT05432583. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Study identification
- NCT ID
- NCT05432583
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- BioNTech SE
- Industry
- Enrollment
- 318 participants
Conditions and interventions
Conditions
Interventions
- BNT163 Biological
- Placebo Other
Biological · Other
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 7, 2022
- Primary completion
- Sep 30, 2026
- Completion
- Sep 30, 2026
- Last update posted
- Oct 19, 2025
2022 – 2026
United States locations
- U.S. sites
- 6
- U.S. states
- 5
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alliance for Multispecialty Research, LLC | Tempe | Arizona | 85281 | — |
| Great Lakes Clinical Trials - Flourish Research | Chicago | Illinois | 60640 | — |
| Accellacare Raleigh Medical Group | Raleigh | North Carolina | 27609 | — |
| Accellacare PMG Research Wilmington LLC | Wilmington | North Carolina | 28401 | — |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05432583, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 19, 2025 · Synced May 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05432583 live on ClinicalTrials.gov.