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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2010-05-31

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.

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Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MRKAd5 HIV-1 gag vaccine 1x10^9 vp/dose

Participants administered MRKAd5 HIV-1 gag vaccine 1x10\^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.

Group Type EXPERIMENTAL

MRKAd5 HIV-1 gag vaccine (V520)

Intervention Type BIOLOGICAL

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

MRKAd5 HIV-1 gag vaccine 1x10^10 vp/dose

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.

Group Type EXPERIMENTAL

MRKAd5 HIV-1 gag vaccine (V520)

Intervention Type BIOLOGICAL

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

Placebo

Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.

Group Type EXPERIMENTAL

Comparator: Placebo

Intervention Type BIOLOGICAL

1.0 mL intramuscular injection of Placebo at Day 1 and Weeks 4 and 26

Open Label Tetanus and Diptheria Toxoids Adsorbed

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.

Group Type SHAM_COMPARATOR

Comparator: Open Label Tetanus and Diptheria Toxoids Adsorbed

Intervention Type BIOLOGICAL

0.5 mL Open Label Tetanus and Diptheria Toxoids Adsorbed (Td) intramuscular injection at Day 1 only

Interventions

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MRKAd5 HIV-1 gag vaccine (V520)

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

Intervention Type BIOLOGICAL

Comparator: Placebo

1.0 mL intramuscular injection of Placebo at Day 1 and Weeks 4 and 26

Intervention Type BIOLOGICAL

Comparator: Open Label Tetanus and Diptheria Toxoids Adsorbed

0.5 mL Open Label Tetanus and Diptheria Toxoids Adsorbed (Td) intramuscular injection at Day 1 only

Intervention Type BIOLOGICAL

MRKAd5 HIV-1 gag vaccine (V520)

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

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No