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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 1

Conditions

Hepatitis C

Treatments

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

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)
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)
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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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