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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
ClinicalTrials.gov Identifier:
NCT00857311
First received: March 4, 2009
Last updated: June 9, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Hepatitis C
 Biological: MRKAd5 HIV-1 gag vaccine (V520)
Biological: Comparator: Placebo
Biological: Comparator: Open Label Tetanus and Diptheria Toxoids Adsorbed
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.



Enrollment: 17
Study Start Date: May 2004
Study Completion Date: May 2010
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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
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.

 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: Placebo
Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
 Biological: Comparator: Placebo
1.0 mL intramuscular injection of Placebo at Day 1 and Weeks 4 and 26
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.

 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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00857311

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00857311     History of Changes
Other Study ID Numbers: V520-022, 2009_556
Study First Received: March 4, 2009
Results First Received: June 9, 2011
Last Updated: June 9, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 23, 2013