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Staged Phase I/II Hepatitis C Prophylactic Vaccine

NCT01436357 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 548

Last updated 2019-11-19

Study results available
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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).

Conditions

  • Hepatitis C

Interventions

BIOLOGICAL

AdCh3NSmut1

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

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.

OTHER

Placebo

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-06
Primary Completion
2018-05-25
Completion
2018-05-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01436357 on ClinicalTrials.gov