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Chiron Corp HCV E1/E2 Vaccine

NCT00500747 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-06-10

No results posted yet for this study

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.

Conditions

  • Hepatitis C

Interventions

BIOLOGICAL

HCV E1E2/MF59

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.

DRUG

Placebo

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

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
2003-08-31
Primary Completion
2005-08-31
Completion
2005-08-31

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT00500747 on ClinicalTrials.gov