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NCT01667341 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity Study of Therapeutic HSV-2 Vaccine
A Phase 1 study, sponsored by Genocea Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 143
- Enrollment target
NCT01667341 is a Phase 1 study that has completed, run by Genocea Biosciences. The registered enrollment target is 143 participants.
The verdict
NCT01667341, a Phase 1 study, has completed, sponsored by Genocea Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 143 participants
- Enrollment target
Study Summary
Randomized, double-blind, placebo-controlled, dose escalation study. There will be 3 cohorts of patients defined by the antigen dose (10, 30 or 100 µg of each antigen), and within each cohort, patients will be randomized at a ratio of 3:1:1 to one of the following: 1. GEN-003/M2: GEN-003 plus Matrix M-2 adjuvant (50 µg per dose) 2. GEN-003: Antigens alone 3. Placebo (DPBS diluent) Each Cohort is divided into 2 Groups. For each dose cohort, immunizations begin with a Pilot Group. Immunization of the remainder of the Group "Continuation Group") is contingent upon successful review of data from the Pilot Group through Day 7 after immunization. Dose escalation to the next dose level Cohort proceeds after evaluation of safety data from all patients in the prior Cohort and only after all specified safety criteria are met. The total numbers of patients in each Group and Cohort are as follows: * 10 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total) * 30 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total) * 100 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total) * Totals per group: 30 Pilot Group, 120 Continuation Group (150 Total Patients) Subjects will receive 3 doses of the assigned treatment (GEN-003/M-2, GEN-003, or placebo) at 3 week intervals. Sampling from mucocutaneous genital sites for viral shedding will be done twice daily for 28 days prior to the first immunization (baseline shedding), and again following the last immunization. Follow-up for safety monitoring will be conducted for 12 months after the last immunization.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL GEN-003
- BIOLOGICAL GEN-003 with Matrix M-2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2012-07 |
| Est. Completion | 2014-05-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01667341
The ClinicalTrials.gov registry entry for NCT01667341 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 143 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genocea Biosciences, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01667341 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01667341 about?
NCT01667341 is a clinical study titled "Safety and Immunogenicity Study of Therapeutic HSV-2 Vaccine". Randomized, double-blind, placebo-controlled, dose escalation study. There will be 3 cohorts of patients defined by the antigen dose (10, 30 or 100 µg of each antigen), and within each cohort, patients will be randomized at a ratio of 3:1:1 to one of the following: 1. GEN-003/M2: GEN-003 plus Matri...
What is the current status of trial NCT01667341?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 143 participants. The study started on 2012-07. Estimated completion is 2014-05-09.
What interventions are being tested in trial NCT01667341?
The interventions under investigation include: Placebo (BIOLOGICAL), GEN-003 (BIOLOGICAL), GEN-003 with Matrix M-2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01667341?
This trial is sponsored by Genocea Biosciences, which has 9 total clinical trials registered on ClinicalTrials.gov.
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