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

Phase 1

Completed

• Conditions: Hepatitis C
• Interventions: Biological: MRKAd5 HIV-1 gag vaccine (V520)

• Registration Number: NCT00857311
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Primary Completion: 2006-01
• Study First Submitted: 2009-03-04
• Study First Submitted QC: 2009-03-05
• Study First Posted: 2009-03-06
• Study Completion: 2010-05
• Results First Submitted: 2011-06-09
• Results First Submitted QC: 2011-06-09
• Results First Posted: 2011-07-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-11
• Last Update Posted: 2015-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Subject who is of reproductive potential agrees to use a acceptable method of birth control through week 52 of the study

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MRKAd5 HIV-1 gag vaccine 1x10^9 vp/dose	MRKAd5 HIV-1 gag vaccine (V520)	Participants administered MRKAd5 HIV-1 gag vaccine 1x10\^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
MRKAd5 HIV-1 gag vaccine 1x10^10 vp/dose	MRKAd5 HIV-1 gag vaccine (V520)	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE)	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	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Systemic and Laboratory Adverse Events (AE)	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	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.
Immune Response by Levels of Unfractionated Gag-specific IFN-gamma Following a 3-dose Vaccine Regimen	Week 30 (4 weeks after boost injection)	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.