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Completed

NCT Number: NCT00857311

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

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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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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: Placebo

Biological

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

Comparator: Open Label Tetanus and Diptheria Toxoids Adsorbed

Biological

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

Primary outcomes

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

    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

    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 outcomes

  1. Number of Participants With Systemic and Laboratory Adverse Events (AE)

    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

    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.

  2. Immune Response by Levels of Unfractionated Gag-specific IFN-gamma Following a 3-dose Vaccine Regimen

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Probe Study With an Additional Open-Label Control Arm to Evaluate the Safety and Immunogenicity of a 3-Dose Regimen of the MRKAd5 HIV-1 Gag Vaccine in Subjects With Chronic Hepatitis C Virus Infection

Important dates

Study start
2004
Primary completion
2006
Study completion
2010
First posted
Mar 6, 2009
Registry last updated
Aug 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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