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NCT02515175 · ClinicalTrials.gov registry record · Phase 2
Evaluating New Formulation of Therapeutic HSV-2 Vaccine
A Phase 2 study of Genital Herpes Simplex Type 2, sponsored by Genocea Biosciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 131
- Enrollment target
- 8
- Study locations
NCT02515175: Completed Phase 2 study of Genital Herpes Simplex Type 2, sponsored by Genocea Biosciences.
NCT02515175 is a Phase 2 study of Genital Herpes Simplex Type 2 that has completed, run by Genocea Biosciences. The registered enrollment target is 131 participants, below the 256-participant average among 3 other Genital Herpes Simplex Type 2 trials with a reported enrollment target (49% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02515175, a Phase 2 study of Genital Herpes Simplex Type 2, has completed, sponsored by Genocea Biosciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 131 participants
- Enrollment target
- 8
- Study locations
Study Summary
This study evaluates the reduction in viral shedding after vaccination with a new formulation of GEN-003 in subjects with genital HSV-2 infection. Two-thirds of the participants will receive GEN-003, one-third will receive placebo.
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Matrix-M2
- BIOLOGICAL GEN-003
Study Locations (8)
California
- Medical Center for Clinical Research - San Diego
- Quest Clinical Research - San Francisco
Alabama
- University of Alabama-Birmingham - Birmingham
Massachusetts
- The Fenway Institute - Boston
North Carolina
- University of North Carolina - Chapel Hill - Chapel Hill
Ohio
- Cincinnati Childrens Hospital - Cincinnati
Texas
- Tekton Research - Austin
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2015-11 |
| Est. Completion | 2017-05-25 |
| Phase | Phase 2 |
What the finished NCT02515175 record still lists
NCT02515175 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, below the 256-participant average among 3 other Genital Herpes Simplex Type 2 trials with a reported enrollment target (49% lower).
The record links to 1 condition, with Genital Herpes Simplex Type 2 appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02515175 lists 8 locations in 7 states (California, Alabama, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT02515175 about?
NCT02515175 is a clinical study titled "Evaluating New Formulation of Therapeutic HSV-2 Vaccine". This study evaluates the reduction in viral shedding after vaccination with a new formulation of GEN-003 in subjects with genital HSV-2 infection. Two-thirds of the participants will receive GEN-003, one-third will receive placebo.
What is the current status of trial NCT02515175?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 131 participants. The study started on 2015-11. Estimated completion is 2017-05-25.
What conditions does trial NCT02515175 study?
This clinical trial studies the following conditions: Genital Herpes Simplex Type 2.
What interventions are being tested in trial NCT02515175?
The interventions under investigation include: Placebo (DRUG), Matrix-M2 (BIOLOGICAL), GEN-003 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02515175?
This trial is sponsored by Genocea Biosciences, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02515175 being conducted?
This trial has 8 study locations across Alabama, California, Massachusetts, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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