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

Merck Sharp & Dohme LLC17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hepatitis C

Interventions

MRKAd5 HIV-1 gag vaccine (V520)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

Comparator: PlaceboBIOLOGICAL

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

Comparator: Open Label Tetanus and Diptheria Toxoids AdsorbedBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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 Outcomes

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.

Time frame: 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.

Time frame: Week 30 (4 weeks after boost injection)

Data from ClinicalTrials.gov

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