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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Biological: Comparator: Open Label Tetanus and Diptheria Toxoids Adsorbed; Biological: MRKAd5 HIV-1 gag vaccine (V520); Biological: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00857311

2009_556

V520-022

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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17 participants in 4 patient groups

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

Experimental group

Description:

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

Treatment:

Biological: MRKAd5 HIV-1 gag vaccine (V520)

Biological: MRKAd5 HIV-1 gag vaccine (V520)

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

Experimental group

Description:

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.

Treatment:

Biological: MRKAd5 HIV-1 gag vaccine (V520)

Biological: MRKAd5 HIV-1 gag vaccine (V520)

Placebo

Experimental group

Description:

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

Treatment:

Biological: Comparator: Placebo

Open Label Tetanus and Diptheria Toxoids Adsorbed

Sham Comparator group

Description:

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.

Treatment:

Biological: Comparator: Open Label Tetanus and Diptheria Toxoids Adsorbed