Staged Phase I/II Hepatitis C Prophylactic Vaccine

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

548 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-06

Study Completion Date

2018-05-25

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

AdCh3NSmut1

Intervention Type BIOLOGICAL

Stages I and II: Receive AdCh3NSmut1 at 2.5 x 10\^10 total virus particles (vp)/dose, intramuscularly on day 0.

MVA-NSmut

Intervention Type BIOLOGICAL

Stages I and II: 1 dose of MVA-NSmut at the dosage 1.8 x10\^8 plaque forming units (pfu) intramuscularly on day 56.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Stages I and II: Two doses of placebo intramuscularly, 1 at day 0 and 1 at day 56.

Interventions

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AdCh3NSmut1

Stages I and II: Receive AdCh3NSmut1 at 2.5 x 10\^10 total virus particles (vp)/dose, intramuscularly on day 0.

Intervention Type BIOLOGICAL

MVA-NSmut

Stages I and II: 1 dose of MVA-NSmut at the dosage 1.8 x10\^8 plaque forming units (pfu) intramuscularly on day 56.

Intervention Type BIOLOGICAL

Placebo

Stages I and II: Two doses of placebo intramuscularly, 1 at day 0 and 1 at day 56.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- Comprehension of informed consent. - 18-45 year old men or women with acknowledged active IDU in the past 90 days and have no travel plans that would interfere with ability to meet the study visit schedule. - In good general health as determined by a participating study physician and results within acceptable ranges for clinical laboratory evaluations as detailed in Appendix A. - Negative for antibodies to hepatitis C virus (anti-HCV). - Negative for HCV RNA. - Negative antibodies to HIV. - Negative for HBsAg. - Able and willing (in the Investigator's opinion) to comply with all study requirements. - Willing to allow the investigators access to their medical records. - Willingness to practice continuous effective contraception from the screening visit through 90 days after the last vaccination (males and females). - Among females, a negative pregnancy test within 24 hours prior to vaccination. - Agreement to refrain from blood donation during the course of the study or after the study. - Provide written informed consent prior to initiation of any study procedures. - Willing to provide contact information for study follow-up activities, including the address, name and contact information of three people who can be contacted to facilitate follow-up compliance.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes