Phase 1
Completed N=17
MRKAd5 HIV-1 Gag Vaccine (V520) in Subjects With Chronic Hepatitis C (V520-022) (COMPLETED)
Source: ClinicalTrials.gov NCT00857311 ↗Enrolled (actual)
17
Serious AEs
23.5%
Results posted
Jul 2011
Primary outcomePrimary: Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE) — 5; 1; 3; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE) |
5; 1; 3; 1; 3; 1 | — |
| SECONDARY Number of Participants With Systemic and Laboratory Adverse Events (AE) |
8; 6; 2; 2; 3; 1 | — |
| SECONDARY Immune Response by Levels of Unfractionated Gag-specific IFN-gamma Following a 3-dose Vaccine Regimen |
— | — |
Eligibility Criteria
Inclusion Criteria
- Subject who is of reproductive potential agrees to use a acceptable method of birth control through week 52 of the study
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00857311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.