At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Staged Phase I/II Study, to Assess Safety, Efficacy and Immunogenicity of a New Hepatitis C Prophylactic Vaccine Based on Sequential Use of AdCh3NSmut1 and MVA-NSmut
In Brief
A Phase 2 clinical trial evaluating AdCh3NSmut1, MVA-NSmut, and 1 other intervention for Hepatitis C. Completed, enrolled 548 participants across 5 sites.
Detailed 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).
Study Details
Timeline
Interventions
Stages I and II: Receive AdCh3NSmut1 at 2.5 x 10\^10 total virus particles (vp)/dose, intramuscularly on day 0.
Stages I and II: 1 dose of MVA-NSmut at the dosage 1.8 x10\^8 plaque forming units (pfu) intramuscularly on day 56.
Stages I and II: Two doses of placebo intramuscularly, 1 at day 0 and 1 at day 56.