Dose Ranging Safety and Efficacy of Therapeutic HSV-2 Vaccine
Public ClinicalTrials.gov record NCT02114060. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Factorial Study to Compare the Safety and Efficacy of Varying Combinations of GEN-003 and Matrix-M2 in Subjects With Genital HSV-2 Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02114060
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 310 participants
Conditions and interventions
Conditions
Interventions
- 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
- Placebo Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2014
- Primary completion
- Jan 31, 2016
- Completion
- Jan 31, 2016
- Last update posted
- Oct 15, 2017
2014 – 2016
United States locations
- U.S. sites
- 16
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Vaccine Research Unit | Birmingham | Alabama | 35294-0006 | — |
| Medical Center for Clinical Research | San Diego | California | 92108 | — |
| Quest Clinical Research | San Francisco | California | 94115 | — |
| University of Illinois Department of Medicine | Chicago | Illinois | 60612 | — |
| Indiana University Infectious Disease Research | Indianapolis | Indiana | 46202 | — |
| The Fenway Institute | Boston | Massachusetts | 02215 | — |
| UNC Global HIV Prevention and Treatment Clinical Trials Unit | Chapel Hill | North Carolina | 27599 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | — |
| Westover Heights Clinic | Portland | Oregon | 97210 | — |
| Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | — |
| Tekton Research | Austin | Texas | 98745 | — |
| Center for Clinical Studies - Houston | Houston | Texas | 77030 | — |
| Center for Clinical Studies | Houston | Texas | 77065 | — |
| Center for Clinical Studies - Clear Lake/Webster | Webster | Texas | 77598 | — |
| University of Utah | Salt Lake City | Utah | 84132 | — |
| UW Virology Research Clinic | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02114060, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 15, 2017 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02114060 live on ClinicalTrials.gov.