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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00857311
First received: March 4, 2009
Last updated: June 9, 2011
Last verified: June 2011

March 4, 2009
June 9, 2011
May 2004
January 2006   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]

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.

Safety and tolerability of a 3-dose prime/boost regimen of MRKAd5 HIV-1 gag vaccine (V520) at 1x10^9 and 1x10^10 vp/dose measured by the number of vaccine related adverse events and ALT levels [ Time Frame: Week 30 (4 weeks post boost injection) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00857311 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Week 30 (4 weeks after boost injection) ] [ Designated as safety issue: No ]

    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.

Safety and Tolerability of a 3-dose prime/boost regimen of MRKAd5 HIV-1 gag vaccine (V520) as measured by local systemic reactions, temperatures and out-of range lab values [ Time Frame: Week 30 (4 weeks post boost injection) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
MRKAd5 HIV-1 Gag Vaccine (V520) in Subjects With Chronic Hepatitis C (V520-022) (COMPLETED)
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hepatitis C
  • Biological: MRKAd5 HIV-1 gag vaccine (V520)
    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
  • Biological: Comparator: Placebo
    1.0 mL intramuscular injection of Placebo at Day 1 and Weeks 4 and 26
  • Biological: Comparator: Open Label Tetanus and Diptheria Toxoids Adsorbed
    0.5 mL Open Label Tetanus and Diptheria Toxoids Adsorbed (Td) intramuscular injection at Day 1 only
  • Biological: MRKAd5 HIV-1 gag vaccine (V520)
    3-dose prime boosting regimen of 1.0-mL intramuscular injections of 1x10^10 viral particles/dose of MRKAd5 HIV-1 gag vaccine (V520) at Day 1 and Weeks 4 and 26
  • Experimental: MRKAd5 HIV-1 gag vaccine 1x10^9 vp/dose
    Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
    Intervention: Biological: MRKAd5 HIV-1 gag vaccine (V520)
  • Experimental: MRKAd5 HIV-1 gag vaccine 1x10^10 vp/dose

    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.

    Intervention: Biological: MRKAd5 HIV-1 gag vaccine (V520)
  • Experimental: Placebo
    Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
    Intervention: Biological: Comparator: Placebo
  • Sham Comparator: Open Label Tetanus and Diptheria Toxoids Adsorbed

    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.

    Intervention: Biological: Comparator: Open Label Tetanus and Diptheria Toxoids Adsorbed
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
May 2010
January 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00857311
V520-022, 2009_556
Yes
Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP