Status:
COMPLETED
MRKAd5 HIV-1 Gag Vaccine (V520) in Subjects With Chronic Hepatitis C (V520-022) (COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
A Study to assess the general safety and tolerability of the administration of a 3-dose prime/boost regimen of the MRKAd5 HIV-1 gag vaccine (V520) in subjects with chronic hepatitis C virus infection.
Eligibility Criteria
Inclusion
- Subject who is of reproductive potential agrees to use a acceptable method of birth control through week 52 of the study
Exclusion
- Subject weighs less than 110 lbs.
- Subject has received treatment for hepatitis C virus infection in the 3 months before enrollment in this study or is anticipated to begin treatment with in 1 year after enrollment
- Subject has any history of anaphylaxis or allergy to vaccine components
- Subject has any history of anaphylaxis or allergy to Tetanus and Diphtheria Toxoids Adsorbed (Td)
- Subject has clinical signs suggestive of cirrhosis
- Subject has had a liver biopsy showing bridging fibrosis or cirrhosis
- Subject is HBsAg positive
- Subject has other known chronic liver disease
- Subject has evidence of hepatocellular carcinoma on liver biopsy
- Subject has had a liver transplant or is anticipated to have a liver transplant within 1 year of enrollment
- Subject has been vaccinated with a live virus vaccine in the past 30 days
- Subject has been vaccinated with an inactive virus vaccine in the past 14 days
- Female subject is pregnant or breast-feeding, Male subject is planning to impregnate
- Subject has active drug or alcohol abuse
- Subject is at high risk for HIV infection
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00857311
Start Date
May 1 2004
End Date
May 1 2010
Last Update
August 25 2015
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