Text Size

Investigation of V520 in a HIV Vaccine Dose Refinement Study (V520-027)(TERMINATED)

This study has been terminated.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00350623
First received: July 7, 2006
Last updated: March 1, 2011
Last verified: March 2011
History of Changes
Results First Received: October 20, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: HIV Infections
Interventions: Biological: MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose (V520)
Biological: MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose (V520)
Biological: MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose (V520)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Phase IIa; First Patient In: 24-Oct-2006; Last Patient Last Visit 30-May-2008. 21 sites, all in the United States of America.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients had to demonstrate good health, be at low risk of acquiring HIV infection, and met a number of laboratory criteria. They could not have previously received an investigational HIV vaccine, had a contraindication to intramuscular injection, or weighed less than 105 pounds.

Reporting Groups
  Description
MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.

Participant Flow:   Overall Study
    MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose     MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose     MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose  
STARTED     71     71     68  
COMPLETED     63     67     62  
NOT COMPLETED     8     4     6  
Lost to Follow-up                 8                 3                 4  
Withdrawal by Subject                 0                 1                 1  
patient traveling outside the country                 0                 0                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
Total Total of all reporting groups

Baseline Measures
    MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose     MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose     MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose     Total  
Number of Participants  
[units: participants]
 		  71     71     68     210  
Age  
[units: years]
Mean ( Full Range ) 		  30.6  
  ( 18 to 50 )   		  31.5  
  ( 18 to 50 )   		  32.0  
  ( 19 to 50 )   		  31.4  
  ( 18 to 50 )  
Gender  
[units: participants]
 		       
Female     31     38     37     106  
Male     40     33     31     104  
Ethnicity  
[units: Participants]
 		       
Hispanic or Latino     9     9     12     30  
Not Hispanic or Latino     62     62     56     180  
Race  
[units: participants]
 		       
Asian     1     2     4     7  
Black or African American     9     9     10     28  
Multi-Racial     4     3     1     8  
Other (Unknown)     0     0     1     1  
White     57     57     52     166  



  Outcome Measures

1.  Primary:   Number of Enzyme-linked Immunosorbent Spot (ELISPOT) Responders at 30 Weeks   [ Time Frame: 30 weeks ]
  Show Outcome Measure 1


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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, V520-023 (NCT00095576), showed that the vaccine used in V520-027 (NCT00350623) was not efficacious; therefore, vaccinations in V520-027 were stopped and only a high level summary of safety data was performed.  


Results Point of Contact:  
Name/Title: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@spcorp.com


No publications provided


Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00350623     History of Changes
Other Study ID Numbers: V520-027, 2006_501
Study First Received: July 7, 2006
Results First Received: October 20, 2010
Last Updated: March 1, 2011
Health Authority: United States: Food and Drug Administration