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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
Results First Received: June 9, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hepatitis C
Interventions: Biological: MRKAd5 HIV-1 gag vaccine (V520)
Biological: Comparator: Placebo
Biological: Comparator: Open Label Tetanus and Diptheria Toxoids Adsorbed

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All participants had to be at low risk of acquiring human immunodeficiency virus (HIV) infection, and had to meet a number of laboratory criteria. They could not have received treatment for hepatitis C virus infection in the 3 months prior to enrollment and must not anticipate to begin treatment with in 1 year after enrollment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.
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.
Placebo Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
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.

Participant Flow:   Overall Study
    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  
STARTED     9     0     8     0  
COMPLETED     8     0     8     0  
NOT COMPLETED     1     0     0     0  
Lost to Follow-up                 1                 0                 0                 0  



  Baseline Characteristics
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Reporting Groups
  Description
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.
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.
Placebo Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
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.
Total Total of all reporting groups

Baseline Measures
    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     Total  
Number of Participants  
[units: participants]
 		  9     0     8     0     17  
Age, Customized  
[units: years]
Mean ( Full Range ) 		  41.4  
  ( 33 to 54 )   		   
    		  39.3  
  ( 22 to 49 )   		   
    		  40.4  
  ( 22 to 54 )  
Gender  
[units: participants]
 		         
Female     5     0     4     0     9  
Male     4     0     4     0     8  
Region of Enrollment  
[units: participants]
 		         
United States     9     0     8     0     17  



  Outcome Measures
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1.  Primary:   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 ]
  Show Outcome Measure 1

2.  Secondary:   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 ]
  Show Outcome Measure 2

3.  Secondary:   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) ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme
e-mail: ClinicalTrialsDisclosure@merck.com


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