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Evaluating New Formulation of Therapeutic HSV-2 Vaccine
NCT02515175 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02515175
The ClinicalTrials.gov registry entry for NCT02515175 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genocea Biosciences, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02515175 reports 8 study locations spanning 7 distinct geographic areas — top geographies include California, Alabama, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02515175?
The interventions under investigation include: Placebo (DRUG), Matrix-M2 (BIOLOGICAL), GEN-003 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02515175?
This trial is sponsored by Genocea Biosciences, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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