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NCT01436357 · ClinicalTrials.gov registry record · Phase 1
Staged Phase I/II Hepatitis C Prophylactic Vaccine
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 548
- Enrollment target
NCT01436357: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01436357 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 548 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (813% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01436357, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 548 participants
- Enrollment target
Study Summary
A two stage, phase I/II, double-blinded, randomized, placebo-controlled study of hepatitis C virus (HCV)uninfected male and female injection drug users (IDU) aged 18 to 45. AdCh3NSmut1 and MVA-NSMut HCV vaccine will be administered to 68 (+/-4) volunteers in stage 1. A planned interim analysis of safety and immunogenicity will be conducted. If no safety signal is detected and there is evidence of a measurable immune response to HCV then 472 (+/-4) volunteers will be enrolled in stage 2. Primary objectives are to 1) assess the safety of AdCh3NSmut1 and MVA-NSmut compared to placebo when administered to HCV-uninfected IDUs and 2) determine if AdCh3NSmut1 and MVA-NSmut HCV vaccines will reduce incidence of chronic HCV infection compared to placebo among HCV-uninfected IDUs. Planned study duration is approx 63 months (accrual time, 2 months vaccination, 18 months follow-up, and 9 months extended observation for subjects becoming viremic in the last month of follow-up).
Primary Outcome
Chronic hepatitis C virus (HCV) infection was defined by persistent viremia over a period of 6 months after initial detection of primary infection.
Interventions
- OTHER Placebo
- BIOLOGICAL AdCh3NSmut1
- BIOLOGICAL MVA-NSmut
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 548 participants |
| Start Date | 2012-03-06 |
| Est. Completion | 2018-05-25 |
| Phase | Phase 1 |
What the finished NCT01436357 record still lists
NCT01436357 is an interventional study that assigns participants to a tested intervention. The registered 548 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (813% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01436357 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01436357 about?
NCT01436357 is a clinical study titled "Staged Phase I/II Hepatitis C Prophylactic Vaccine". A two stage, phase I/II, double-blinded, randomized, placebo-controlled study of hepatitis C virus (HCV)uninfected male and female injection drug users (IDU) aged 18 to 45. AdCh3NSmut1 and MVA-NSMut HCV vaccine will be administered to 68 (+/-4) volunteers in stage 1. A planned interim analysis of sa...
What is the current status of trial NCT01436357?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 548 participants. The study started on 2012-03-06. Estimated completion is 2018-05-25.
What interventions are being tested in trial NCT01436357?
The interventions under investigation include: Placebo (OTHER), AdCh3NSmut1 (BIOLOGICAL), MVA-NSmut (BIOLOGICAL).
Who is sponsoring clinical trial NCT01436357?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01436357's enrollment target sits among peer trials
548 35th of 2000 higher than 1,966 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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