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NCT05432583 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Genital Herpes Simplex Type 2, sponsored by BioNTech SE.
- Active
- Registry status
- Phase 1
- Development phase
- 318
- Enrollment target
- 6
- Study locations
NCT05432583: Active Phase 1 study of Genital Herpes Simplex Type 2, sponsored by BioNTech SE.
NCT05432583 is a Phase 1 study of Genital Herpes Simplex Type 2 that is active but no longer recruiting, run by BioNTech SE. The registered enrollment target is 318 participants, above the 194-participant average among 3 other Genital Herpes Simplex Type 2 trials with a reported enrollment target (64% higher). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05432583, a Phase 1 study of Genital Herpes Simplex Type 2, is active but no longer recruiting, sponsored by BioNTech SE.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 318 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
For each dose level (DL) per BNT163 dosing schedule and for the combined placebo group.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL BNT163
Study Locations (6)
North Carolina
- Accellacare Raleigh Medical Group - Raleigh
- Accellacare PMG Research Wilmington LLC - Wilmington
Arizona
- Alliance for Multispecialty Research, LLC - Tempe
Illinois
- Great Lakes Clinical Trials - Flourish Research - Chicago
Ohio
- CTI Clinical Research Center - Cincinnati
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 318 participants |
| Start Date | 2022-12-08 |
| Est. Completion | 2026-10 |
| Phase | Phase 1 |
What the registry record for NCT05432583 still lists
NCT05432583 is an interventional study that assigns participants to a tested intervention. The registered 318 participants enrollment target is mid-sized for trials with a published cap, above the 194-participant average among 3 other Genital Herpes Simplex Type 2 trials with a reported enrollment target (64% higher).
The record links to 1 condition, with Genital Herpes Simplex Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05432583 lists 6 locations in 5 states (North Carolina, Arizona, Illinois).
Frequently Asked Questions
What is clinical trial NCT05432583 about?
NCT05432583 is a clinical study titled "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". 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 ad...
What is the current status of trial NCT05432583?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 318 participants. The study started on 2022-12-08. Estimated completion is 2026-10.
What conditions does trial NCT05432583 study?
This clinical trial studies the following conditions: Genital Herpes Simplex Type 2.
What interventions are being tested in trial NCT05432583?
The interventions under investigation include: Placebo (OTHER), BNT163 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05432583?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05432583 being conducted?
This trial has 6 study locations across Arizona, Illinois, North Carolina, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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