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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 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.

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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.

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

FieldValue
Enrollment Target 131 participants
Start Date 2015-11
Est. Completion 2017-05-25
Phase Phase 2

Sponsor

Genocea Biosciences

9 total trials

What the Registry Record Tells You About NCT02515175

The ClinicalTrials.gov registry entry for NCT02515175 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 256-participant average among 3 other Genital Herpes Simplex Type 2 trials with a reported enrollment target (49% lower). The listed sponsor is Genocea Biosciences, which has 9 total studies on file at ClinicalTrials.gov.

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 reports 8 study locations spanning 7 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.