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: June 9, 2011
Last verified: June 2011
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     0     4     0     9  
Male     4     0     4     0     8  
Region of Enrollment  
[units: participants]
         
United States     9     0     8     0     17  



  Outcome Measures
  Show All Outcome Measures

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 ]

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 ]

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) ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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.

Other Adverse Events
    MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose     Placebo  
Total, other (not including serious) adverse events      
# participants affected / at risk     9/9     6/8  
Cardiac disorders      
Palpitations † 1    
# participants affected / at risk     1/9 (11.11%)     0/8 (0.00%)  
Eye disorders      
Eye oedema † 1    
# participants affected / at risk     1/9 (11.11%)     0/8 (0.00%)  
Gastrointestinal disorders      
Abdominal pain † 1    
# participants affected / at risk     1/9 (11.11%)     0/8 (0.00%)  
Diarrhoea † 1    
# participants affected / at risk     3/9 (33.33%)     1/8 (12.50%)  
Haemorrhoids † 1    
# participants affected / at risk     0/9 (0.00%)     1/8 (12.50%)  
Nausea † 1    
# participants affected / at risk     1/9 (11.11%)     1/8 (12.50%)  
Vomiting † 1    
# participants affected / at risk     2/9 (22.22%)     1/8 (12.50%)  
General disorders      
Adverse drug reaction † 1    
# participants affected / at risk     1/9 (11.11%)     0/8 (0.00%)  
Asthenia † 1    
# participants affected / at risk     1/9 (11.11%)     0/8 (0.00%)  
Chest pain † 1    
# participants affected / at risk     1/9 (11.11%)     0/8 (0.00%)  
Chills † 1    
# participants affected / at risk     2/9 (22.22%)     1/8 (12.50%)  
Fatigue † 1    
# participants affected / at risk     1/9 (11.11%)     1/8 (12.50%)  
Feeling hot † 1    
# participants affected / at risk     1/9 (11.11%)     0/8 (0.00%)  
Injection Site Erythema † 1    
# participants affected / at risk     2/9 (22.22%)     0/8 (0.00%)  
Injection Site Pain † 1    
# participants affected / at risk     3/9 (33.33%)     1/8 (12.50%)  
Oedema peripheral † 1    
# participants affected / at risk     1/9 (11.11%)     0/8 (0.00%)  
Pain † 1    
# participants affected / at risk     1/9 (11.11%)     1/8 (12.50%)  
Pyrexia † 1    
# participants affected / at risk     3/9 (33.33%)     1/8 (12.50%)  
Thirst † 1    
# participants affected / at risk     1/9 (11.11%)     0/8 (0.00%)  
Infections and infestations      
Cystitis † 1    
# participants affected / at risk     1/9 (11.11%)     0/8 (0.00%)  
Nasopharyngitis † 1    
# participants affected / at risk     1/9 (11.11%)     0/8 (0.00%)  
Injury, poisoning and procedural complications      
Joint sprain † 1    
# participants affected / at risk     0/9 (0.00%)     1/8 (12.50%)  
Laceration † 1    
# participants affected / at risk     0/9 (0.00%)     1/8 (12.50%)  
Procedural pain † 1    
# participants affected / at risk     0/9 (0.00%)     1/8 (12.50%)  
Investigations      
Alkaline phosphatase increased † 1    
# participants affected / at risk     0/9 (0.00%)     1/8 (12.50%)  
Aspartate aminotransferase increased † 1    
# participants affected / at risk     3/9 (33.33%)     0/8 (0.00%)  
Haemoglobin decreased † 1    
# participants affected / at risk     1/9 (11.11%)     0/8 (0.00%)  
Musculoskeletal and connective tissue disorders      
Myalgia † 1    
# participants affected / at risk     2/9 (22.22%)     0/8 (0.00%)  
Pain in extremity † 1    
# participants affected / at risk     1/9 (11.11%)     0/8 (0.00%)  
Nervous system disorders      
Dizziness † 1    
# participants affected / at risk     2/9 (22.22%)     0/8 (0.00%)  
Headache † 1    
# participants affected / at risk     2/9 (22.22%)     1/8 (12.50%)  
Sciatica † 1    
# participants affected / at risk     0/9 (0.00%)     1/8 (12.50%)  
Psychiatric disorders      
Alcohol abuse † 1    
# participants affected / at risk     0/9 (0.00%)     1/8 (12.50%)  
Dependence † 1    
# participants affected / at risk     0/9 (0.00%)     1/8 (12.50%)  
Depression † 1    
# participants affected / at risk     1/9 (11.11%)     0/8 (0.00%)  
Respiratory, thoracic and mediastinal disorders      
Nasal congestion † 1    
# participants affected / at risk     1/9 (11.11%)     0/8 (0.00%)  
Oropharyngeal pain † 1    
# participants affected / at risk     1/9 (11.11%)     0/8 (0.00%)  
Sneezing † 1    
# participants affected / at risk     0/9 (0.00%)     1/8 (12.50%)  
Skin and subcutaneous tissue disorders      
Acne † 1    
# participants affected / at risk     1/9 (11.11%)     0/8 (0.00%)  
Pruritus † 1    
# participants affected / at risk     1/9 (11.11%)     0/8 (0.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (13.0)



  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.


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