At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 60 enrolled

Drug / intervention

HCV E1E2/MF59 +1 morebiological

Likely dose

HCV E1E2/MF59 0.5 mLfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00500747

NCT00500747Phase 1Completed

Compare CT.gov

A Phase I Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Immunogenicity of Chiron Corporation's HCV E1E2/MF59 Vaccine Administered to Healthy HCV-Negative Adults

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jul 13, 2007·Updated Jun 10, 2011

In Brief

A Phase 1 clinical trial evaluating HCV E1E2/MF59 and Placebo for Hepatitis C. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The purposes of this study are to evaluate the safety, tolerability, and effectiveness of a vaccine (the HCV E1/E2/MF59 vaccine) against hepatitis C (HCV). The vaccine will be given to 60 healthy adult volunteers (aged 18-45 years) and the study will compare the immune system (the body's protective response) response to the HCV E1/E2 vaccine given at different dosage levels: 4 micrograms, 20 micrograms, or 100 micrograms in MF59 adjuvant (substance that can improve vaccine effectiveness). The volunteers will be assigned randomly (by chance) to 1 of 4 different groups. Volunteers in each group will receive a shot of the vaccine or a placebo (shot with no medication). Participants will be involved in study related procedures for up to 71 weeks, which includes blood samples, recording symptoms on a diary card, and 4 vaccine or placebo injections.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHepatitis C

CountriesUnited States

Collaborators--

Timeline

Phase 1CompletedFinished

2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartAug 2003

Primary CompletionAug 2005

First PostedJul 2007

TodayJul 2026

First PostedJul 13, 2007

Enrollment StartAug 1, 2003

Primary CompletionAug 1, 2005

TodayJul 2, 2026

Enrollment to primary: 2 yearsPosted 19.0 years ago

Interventions

HCV E1E2/MF59biological

The investigational vaccine contains envelope glycoproteins gpE1 and gpE2 and the adjuvant, MF59. MF59 is a sterile oil-in-water emulsion in a citrate buffer, which comprises 50 percent of the vaccine. The antigen and adjuvant are combined prior to the injection. The volume to be administered is 0.5 mL for all vaccine dose levels. The vaccine has a milky white opacity. Vaccine dosages: 4 mcg, 20 mcg and 100 mcg.

Placebodrug

Four doses sterile saline (0.5 mL total volume) at 0, 4, 24, and 28 weeks.