MRKAd5 HIV-1 Gag Vaccine (V520) in Subjects With Chronic Hepatitis C (V520-022) (COMPLETED)

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Double-Blind, Randomized, Placebo-Controlled Probe Study With an Additional Open-Label Control Arm to Evaluate the Safety and Immunogenicity of a 3-Dose Regimen of the MRKAd5 HIV-1 Gag Vaccine in Subjects With Chronic Hepatitis C Virus Infection

Conditions
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Hepatitis C

Intervention / Treatment
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* Biological: MRKAd5 HIV-1 gag vaccine (V520)
* Biological: Comparator: Placebo
* Biological: Comparator: Open Label Tetanus and Diptheria Toxoids Adsorbed
* Biological: MRKAd5 HIV-1 gag vaccine (V520)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRKAd5 HIV-1 gag vaccine 1x10^9 vp/dose<br>Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26. | Biological: MRKAd5 HIV-1 gag vaccine (V520)<br>* 3-dose prime boosting regimen of 1.0-mL intramuscular injections of 1x10^9 viral particles/dose of MRKAd5 HIV-1 gag vaccine (V520) at Day 1 and Weeks 4 and 26<br>|
| Experimental: MRKAd5 HIV-1 gag vaccine 1x10^10 vp/dose<br>Participants were to be administered MRKAd5 HIV-1 gag 1x10^10 vp/dose (V520) on Day 1, Week 4, and Week 26. Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in the group MRKAd5 HIV-1 gag 1x10^10 vp/dose. | Biological: MRKAd5 HIV-1 gag vaccine (V520)<br>* 3-dose prime boosting regimen of 1.0-mL intramuscular injections of 1x10^10 viral particles/dose of MRKAd5 HIV-1 gag vaccine (V520) at Day 1 and Weeks 4 and 26<br>|
| Experimental: Placebo<br>Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26. | Biological: Comparator: Placebo<br>* 1.0 mL intramuscular injection of Placebo at Day 1 and Weeks 4 and 26<br>|
| Sham Comparator: Open Label Tetanus and Diptheria Toxoids Adsorbed<br>Participants were to be administered open label tetanus and diptheria toxoids adsorbed (Td) at Day 1 only. Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in this group. | Biological: Comparator: Open Label Tetanus and Diptheria Toxoids Adsorbed<br>* 0.5 mL Open Label Tetanus and Diptheria Toxoids Adsorbed (Td) intramuscular injection at Day 1 only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE) | Serious and non serious clinical (systemic and injection-site AEs), and laboratory AEs were collected. Systemic and laboratory AEs reflect any unfavorable & unintended change in the structure, function, or chemistry of the body. Injection-site AEs include any swelling, redness, pain or tenderness at the injection site. Vaccine-related AEs are those determined by the investigator to be possibly, probably, or definitely related to the administration of the vaccine. | up to Week 78 (52 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Systemic and Laboratory Adverse Events (AE) | Adverse experiences collected include serious and non serious systemic AEs, injection-site AEs, and laboratory AEs. Systemic and laboratory AEs include any unfavorable & unintended change in the structure, function, or chemistry of the body. Injection-site AEs include any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to 5 days after any vaccine dose. | up to Week 260 (234 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs | 
| Immune Response by Levels of Unfractionated Gag-specific IFN-gamma Following a 3-dose Vaccine Regimen | Participants expressing HIV antigens (gag) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag-specific IFN-gamma were to be measured using an Enzyme Linked Immunospot Assay (ELISPOT), which measures spot forming cells per 10^6 peripheral blood mononuclear cells (SFC per million PBMCs). No immunogenicity analyses were performed because the results from a previous study, V520-023 (NCT00095576), which used the same vaccine as the one used in this study (NCT00857311) proved it was not efficacious. | Week 30 (4 weeks after boost injection) |