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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: Completed Phase 2 study, sponsored by Genocea Biosciences.
NCT02300142 is a Phase 2 study that has completed, run by Genocea Biosciences. The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT02300142 record still lists
NCT02300142 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 5 interventions - of which GEN-003 Vaccine (30μg of each antigen) is the first listed.
NCT02300142 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT02300142's enrollment target sits among peer trials
37 1484th of 2000 higher than 505 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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