Staged Phase I/II Hepatitis C Prophylactic Vaccine
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1/Phase 2

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).
    

Detailed description: 
      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. In this
      clinical trial AdCh3NSmut1 and MVA-NSMut HCV vaccine will be administered intramuscularly to
      68 (+/-4) evaluable volunteers in stage 1. A planned interim analysis of safety and
      immunogenicity will be conducted based on data through 1 week after receipt of the second
      vaccination. If no safety signal is detected and there is evidence of a measurable immune
      response to HCV then an additional 472 (+/-4) volunteers will be enrolled in stage 2. The
      primary objectives of this study will be 1) to assess the safety of the new candidate
      hepatitis C virus vaccines, AdCh3NSmut1 and MVA-NSmut, compared to placebo when administered
      to HCV-uninfected injection drug users (IDUs) and 2) to determine if AdCh3NSmut1 and
      MVA-NSmut HCV vaccines will reduce incidence of chronic HCV infection compared to placebo
      among HCV-uninfected IDUs. The secondary objective of this study will be to evaluate the
      immunogenicity of the new candidate hepatitis C virus vaccines, AdCh3NSmut1 and MVA-NSmut,
      compared to placebo when administered to HCV-uninfected IDUs.The planned duration of the
      study is approximately 63 months total including accrual time for subjects (assuming 31
      months of screening/enrollments, plus 3 months of halted enrollment for the first interim
      analysis), 2 months vaccination, 18 months follow-up of each enrolled subject, and 9 months
      extended observation (monthly), from the time of infection, for subjects becoming viremic in
      the last month of follow-up.
    

Intervention name(s): AdCh3NSmut1; MVA-NSmut; Placebo
Intervention type(s): Biological; Biological; Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: AdCh3NSmut1; Hepatitis C; MVA-NSmut; vaccine