Staged Phase I/II Hepatitis C Prophylactic Vaccine
Phase I/II, double-blinded, randomized, placebo-controlled study of HCV-uninfected male and female active IDU aged 18 to 45 years. In Stage I 68 (+/-4) evaluable subjects will be enrolled and then an interim analysis of safety data will be performed. In Stage II an additional 382 (+/-4) subjects will be enrolled.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||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|
- Occurrence of severe local and/or systemic solicited reactogenicity signs and symptoms in the 8 days (Day 0-7) after each vaccination, per treatment arm. [ Time Frame: Day 0 to 7 ] [ Designated as safety issue: Yes ]
- Occurrence of vaccine-related serious adverse events (SAEs) from the time of first vaccination through the entire study period, per treatment arm. [ Time Frame: Day 0 to 29 months ] [ Designated as safety issue: Yes ]
- Incidence of chronic hepatitis C virus (HCV) infection at 6 months defined by persistent viremia over a period of 6 months after initial detection of primary infection. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Occurrence of clinical safety laboratory adverse events (AEs) assessed at baseline and 1 month following each vaccination, per treatment arm. [ Time Frame: Day 0 to 1 month ] [ Designated as safety issue: Yes ]
- Frequency of positive cell mediated immune response by treatment group (vaccine vs. placebo) measured by interferon gamma (IFN-gamma) production by T-cells in response to at least one out of the six HCV genotype 1b peptide pools in the vaccine. [ Time Frame: Within 14 days after the last vaccination (Day 56) ] [ Designated as safety issue: No ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Placebo Comparator: Arm B (Stage I and II)
Two doses of placebo intramuscularly, 1 at day 0 and 1 at day 56: 34 (+/-2) subjects Stage I, then 191 (+/-2) subjects at Stage II.
Stages I and II: Two doses of placebo intramuscularly, 1 at day 0 and 1 at day 56.
Experimental: Arm A (Stage I and II)
Receive AdCh3NSmut1 at 2.5 x 10^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10^8 plaque forming units (pfu): 34 (+/-2) subjects Stage I, then 191 (+/-2) subjects at Stage II.
Stages I and II: 1 dose of MVA-NSmut at the dosage 1.8 x10^8 plaque forming units (pfu) intramuscularly on day 56.Biological: AdCh3NSmut1
Stages I and II: Receive AdCh3NSmut1 at 2.5 x 10^10 total virus particles (vp)/dose, intramuscularly on day 0.
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 382 (+/-4) volunteers will be enrolled in stage 2.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436357
|Contact: Andrea L Cox||(410) firstname.lastname@example.org|
|United States, California|
|University of California San Francisco - Tenderloin Clinical Research Center||Recruiting|
|San Francisco, California, United States, 94102-4012|
|United States, Maryland|
|Johns Hopkins School of Public Health - Wood Clinic||Recruiting|
|Baltimore, Maryland, United States, 21205-2400|