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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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00857311
First received: March 4, 2009
Last updated: November 12, 2014
Last verified: November 2014
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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

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         4         9  
Male     4         4         8  
Region of Enrollment  
[units: participants]
         
United States     9         8         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 ]

Measure Type Primary
Measure Title Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE)
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.
Placebo Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.

Measured Values
    MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose     Placebo  
Number of Participants Analyzed  
[units: participants]
  9     8  
Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE)  
[units: Participants]
   
With non-serious vaccine-related (VR) clinical AEs     5     1  
---With non-serious VR systemic AEs     3     1  
---With non-serious VR injection-site AEs     3     1  
With serious VR clinical AEs     0     0  
---With serious VR systemic AEs     0     0  
---With serious VR injection-site AEs     0     0  
With non-serious VR laboratory AEs     2     0  
With serious VR laboratory AEs     0     0  
discontinued due to non-serious VR clinical AE     0     0  
discontinued due to serious VR clinical AE     0     0  
discontinued due to VR non-serious laboratory AE     0     0  
discontinued due to VR serious laboratory AE     0     0  

No statistical analysis provided for Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE)



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 ]

Measure Type Secondary
Measure Title Number of Participants With Systemic and Laboratory Adverse Events (AE)
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.
Placebo Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.

Measured Values
    MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose     Placebo  
Number of Participants Analyzed  
[units: participants]
  9     8  
Number of Participants With Systemic and Laboratory Adverse Events (AE)  
[units: Participants]
   
With non-serious systemic AEs     8     6  
With serious systemic AEs     2     2  
With non-serious injection-site AEs     3     1  
With serious injection-site AEs     0     0  
With non-serious laboratory AEs     4     1  
With serious laboratory AEs     0     0  

No statistical analysis provided for Number of Participants With Systemic and Laboratory Adverse Events (AE)



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) ]

Measure Type Secondary
Measure Title Immune Response by Levels of Unfractionated Gag-specific IFN-gamma Following a 3-dose Vaccine Regimen
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No analysis was performed.

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

Measured Values
    MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose     Placebo  
Number of Participants Analyzed  
[units: participants]
  0     0  
Immune Response by Levels of Unfractionated Gag-specific IFN-gamma Following a 3-dose Vaccine Regimen          

No statistical analysis provided for Immune Response by Levels of Unfractionated Gag-specific IFN-gamma Following a 3-dose Vaccine Regimen




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


  More Information