Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02300142 · ClinicalTrials.gov registry record · Phase 2
Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 Study
A Phase 2 study, sponsored by Genocea Biosciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
NCT02300142 is a Phase 2 study that has completed, run by Genocea Biosciences. The registered enrollment target is 37 participants.
The verdict
NCT02300142, a Phase 2 study, has completed, sponsored by Genocea Biosciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
Study Summary
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.
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)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2015-01 |
| Est. Completion | 2016-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02300142
The ClinicalTrials.gov registry entry for NCT02300142 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 37 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 5 interventions - of which GEN-003 Vaccine (30μg of each antigen) is the first listed.
NCT02300142 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02300142 about?
NCT02300142 is a clinical study titled "Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 Study". 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 combina...
What is the current status of trial NCT02300142?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2015-01. Estimated completion is 2016-06.
What interventions are being tested in trial NCT02300142?
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 NCT02300142?
This trial is sponsored by Genocea Biosciences, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
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.