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Dose Ranging Safety and Efficacy of Therapeutic HSV-2 Vaccine
NCT02114060 · View on ClinicalTrials.gov ↗
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 |
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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. 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 310 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 5 interventions — of which GEN-003 Vaccine (30μg of each antigen) 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: NCT02114060 reports 16 study locations spanning 12 distinct geographic areas — top geographies include Texas, California, Alabama. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02114060?
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 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.
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