Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02114060 · ClinicalTrials.gov registry record · Phase 2
Dose Ranging Safety and Efficacy 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
- 310
- Enrollment target
- 16
- Study locations
NCT02114060 is a Phase 2 study of Genital Herpes Simplex Type 2 that has completed, run by Genocea Biosciences. The registered enrollment target is 310 participants, above the 196-participant average among 3 other Genital Herpes Simplex Type 2 trials with a reported enrollment target (58% higher). The trial reports 16 study locations across 12 states.
The verdict
NCT02114060, a Phase 2 study of Genital Herpes Simplex Type 2, has completed, sponsored by Genocea Biosciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 310 participants
- Enrollment target
- 16
- Study locations
Study Summary
This is a randomized, double-blind, factorial study to compare the reduction in viral shedding among 6 different combinations of GEN-003, a therapeutic HSV-2 vaccine and Matrix-M2 adjuvant. Secondary objectives of the study include: * Evaluation of the safety and tolerability of GEN-003 in combination with Matrix-M2 compared to placebo. * Comparison of the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among the 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by: * Time to first clinical and/or virologic recurrence, * Proportion of subjects who are recurrence free at 6 and 12 months after the last dose of vaccine, * Lesion rate (percent of days with genital lesions present) during the post-vaccination swabbing periods. * Evaluation of cellular and humoral responses to GEN-003 antigens. Additional objectives include: * Assessment of the correlation between immune responses and change in viral shedding or impact on clinical disease as defined above. * Determination of the recurrence rate in a subset of subjects not receiving suppressive antivirals throughout the study. Eligible subjects will enter a baseline period to collect anogenital swabs for 28 consecutive days prior to randomization. Each subject will receive up to 3 doses at 21 day intervals. Subjects will be followed for safety and immunologic response for 12 months following their last dose.
Conditions Studied
Interventions
- BIOLOGICAL GEN-003 Vaccine (30μg of each antigen)
- BIOLOGICAL GEN-003 Vaccine (60μg of each antigen)
- BIOLOGICAL Matrix-M2 Adjuvant (25μg)
- BIOLOGICAL Matrix-M2 Adjuvant (50μg)
- BIOLOGICAL Matrix-M2 Adjuvant (75μg)
Study Locations (16)
Texas
- Tekton Research - Austin
- Center for Clinical Studies - Houston - Houston
- Center for Clinical Studies - Houston
- Center for Clinical Studies - Clear Lake/Webster - Webster
California
- Medical Center for Clinical Research - San Diego
- Quest Clinical Research - San Francisco
Alabama
- University of Alabama Vaccine Research Unit - Birmingham
Illinois
- University of Illinois Department of Medicine - Chicago
Indiana
- Indiana University Infectious Disease Research - Indianapolis
Massachusetts
- The Fenway Institute - Boston
North Carolina
- UNC Global HIV Prevention and Treatment Clinical Trials Unit - Chapel Hill
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 310 participants |
| Start Date | 2014-07 |
| Est. Completion | 2016-02 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02114060
The ClinicalTrials.gov registry entry for NCT02114060 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 310 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 196-participant average among 3 other Genital Herpes Simplex Type 2 trials with a reported enrollment target (58% higher). 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 5 interventions - of which GEN-003 Vaccine (30μg of each antigen) is the first listed.
NCT02114060 reports 16 study locations spanning 12 distinct geographic areas - top geographies include Texas, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT02114060 about?
NCT02114060 is a clinical study titled "Dose Ranging Safety and Efficacy of Therapeutic HSV-2 Vaccine". This is a randomized, double-blind, factorial study to compare the reduction in viral shedding among 6 different combinations of GEN-003, a therapeutic HSV-2 vaccine and Matrix-M2 adjuvant. Secondary objectives of the study include: * Evaluation of the safety and tolerability of GEN-003 in combina...
What is the current status of trial NCT02114060?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 310 participants. The study started on 2014-07. Estimated completion is 2016-02.
What conditions does trial NCT02114060 study?
This clinical trial studies the following conditions: Genital Herpes Simplex Type 2.
What interventions are being tested in trial NCT02114060?
The interventions under investigation include: GEN-003 Vaccine (30μg of each antigen) (BIOLOGICAL), GEN-003 Vaccine (60μg of each antigen) (BIOLOGICAL), Matrix-M2 Adjuvant (25μg) (BIOLOGICAL), Matrix-M2 Adjuvant (50μg) (BIOLOGICAL), Matrix-M2 Adjuvant (75μg) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02114060?
This trial is sponsored by Genocea Biosciences, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02114060 being conducted?
This trial has 16 study locations across Alabama, California, Illinois, Indiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Genital Herpes Simplex Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Evaluating New Formulation of Therapeutic HSV-2 Vaccine
COMPLETED · Phase 2
-
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
ACTIVE NOT RECRUITING · Phase 1
-
Long-term Follow-up of GEN-003-002 Subjects for Efficacy and Immunogenicity
COMPLETED
Read our methodology - how this data is sourced, computed, and verified.
Related
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.