Back to resultsMRKAd5 HIV-1 Gag Vaccine (V520) in Subjects With Chronic Hepatitis C (V520-022) (COMPLETED)
Primary Purpose
Hepatitis C
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MRKAd5 HIV-1 gag vaccine (V520)
Comparator: Placebo
Comparator: Open Label Tetanus and Diptheria Toxoids Adsorbed
MRKAd5 HIV-1 gag vaccine (V520)
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Sham Comparator
Arm Label
MRKAd5 HIV-1 gag vaccine 1x10^9 vp/dose
MRKAd5 HIV-1 gag vaccine 1x10^10 vp/dose
Placebo
Open Label Tetanus and Diptheria Toxoids Adsorbed
Arm Description
Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
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.
Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00857311
Brief Title
MRKAd5 HIV-1 Gag Vaccine (V520) in Subjects With Chronic Hepatitis C (V520-022) (COMPLETED)
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRKAd5 HIV-1 gag vaccine 1x10^9 vp/dose
Arm Type
Experimental
Arm Description
Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
Arm Title
MRKAd5 HIV-1 gag vaccine 1x10^10 vp/dose
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
Arm Title
Open Label Tetanus and Diptheria Toxoids Adsorbed
Arm Type
Sham Comparator
Arm Description
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 Type
Biological
Intervention Name(s)
MRKAd5 HIV-1 gag vaccine (V520)
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Comparator: Placebo
Intervention Description
1.0 mL intramuscular injection of Placebo at Day 1 and Weeks 4 and 26
Intervention Type
Biological
Intervention Name(s)
Comparator: Open Label Tetanus and Diptheria Toxoids Adsorbed
Intervention Description
0.5 mL Open Label Tetanus and Diptheria Toxoids Adsorbed (Td) intramuscular injection at Day 1 only
Intervention Type
Biological
Intervention Name(s)
MRKAd5 HIV-1 gag vaccine (V520)
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE)
Description
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 Outcome Measure Information:
Title
Number of Participants With Systemic and Laboratory Adverse Events (AE)
Description
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
Title
Immune Response by Levels of Unfractionated Gag-specific IFN-gamma Following a 3-dose Vaccine Regimen
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
MRKAd5 HIV-1 Gag Vaccine (V520) in Subjects With Chronic Hepatitis C (V520-022) (COMPLETED)
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