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
2 other identifiers
interventional
17
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2004
Longer than P75 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 4, 2009
CompletedFirst Posted
Study publicly available on registry
March 6, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
July 7, 2011
CompletedAugust 25, 2015
August 1, 2015
1.7 years
March 4, 2009
June 9, 2011
August 11, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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 (2)
Number of Participants With Systemic and Laboratory Adverse Events (AE)
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
Week 30 (4 weeks after boost injection)
Study Arms (4)
MRKAd5 HIV-1 gag vaccine 1x10^9 vp/dose
EXPERIMENTALParticipants administered MRKAd5 HIV-1 gag vaccine 1x10\^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
MRKAd5 HIV-1 gag vaccine 1x10^10 vp/dose
EXPERIMENTALParticipants 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.
Placebo
EXPERIMENTALParticipants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
Open Label Tetanus and Diptheria Toxoids Adsorbed
SHAM COMPARATORParticipants 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.
Interventions
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
1.0 mL intramuscular injection of Placebo at Day 1 and Weeks 4 and 26
0.5 mL Open Label Tetanus and Diptheria Toxoids Adsorbed (Td) intramuscular injection at Day 1 only
Eligibility Criteria
You may qualify if:
- Subject who is of reproductive potential agrees to use a acceptable method of birth control through week 52 of the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
An interim analysis of a related study, V520 Protocol 023 (NCT00095576), showed that the MRKAd5 vaccine used in Protocol 022 (NCT00857311) was not efficacious; therefore, only a high level summary of the safety data was performed.
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2009
First Posted
March 6, 2009
Study Start
May 1, 2004
Primary Completion
January 1, 2006
Study Completion
May 1, 2010
Last Updated
August 25, 2015
Results First Posted
July 7, 2011
Record last verified: 2015-08