Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 Study
Public ClinicalTrials.gov record NCT02300142. 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
Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 - Randomized, Double-Blind, Factorial Study to Compare the Safety and Efficacy of Combinations of GEN-003 and Matrix-M2 in Subjects With Genital HSV-2
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a voluntary study to allow subjects who received placebo while on GEN-003-002 to be randomized, in a blinded manner, to 1 of 6 active combinations of GEN-003 and Matrix-M2. Objectives: * To compare the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by: * Time to first clinical and/or virologic recurrence after Dose 3 (Day 43) * 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 follow-up period * Antiviral use. * To evaluate the safety and tolerability of GEN-003 in combination with Matrix-M2.
Study identification
- NCT ID
- NCT02300142
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 37 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
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
- Dec 31, 2014
- Primary completion
- May 31, 2016
- Completion
- May 31, 2016
- Last update posted
- Oct 15, 2017
2015 – 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 NCT02300142, 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 NCT02300142 live on ClinicalTrials.gov.