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TG4040 in Patients With Chronic HCV

NCT00449124 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2019-01-23

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and effectiveness of an investigational vaccine (TG4040) to prevent hepatitis C virus (HCV) infection. The primary goal of this study is to determine the safety of increasing doses of TG4040 versus placebo (an inactive substance) in subjects chronically infected with HCV. Approximately 85 patients, ages 18-65 years, with chronic HCV infection will be enrolled in this study at two sites, Saint Louis University and Cincinnati Children's Hospital. Volunteers will receive doses of TG4040 and placebo by injections into the thigh on different days, depending on which study group they belong to. Safety will be checked before doses are increased, and each participant will receive the study vaccine, TG4040, at some point during the study. Each subject will participate in the study for 8 months. This study may help produce a new vaccine that would improve control of HCV.

Conditions

  • Hepatitis C

Interventions

DRUG

Placebo

Injections of 0.5 mL of normal saline solution (0.9% NaCl).

BIOLOGICAL

TG4040

Modified vaccinia virus Ankara encoding hepatitis C virus (HCV) proteins NS3, NS4, and NS5B administered by subcutaneous injection into the thigh. Dosages: TG4040 10\^6 PFU, TG4040 10\^7 PFU and TG4040 10\^8 PFU.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2007-09-30
Completion
2007-09-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT00449124 on ClinicalTrials.gov