Immunogenicity to Human Papillomavirus Vaccine (Gardasil) Among IBD Patients on Immunosuppressive Therapy (HPV)

This study has been completed.
Sponsor:
Collaborators:
Harvard School of Public Health
Merck Sharp & Dohme Corp.
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00727636
First received: July 31, 2008
Last updated: May 3, 2011
Last verified: May 2011
Results First Received: May 3, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Inflammatory Bowel Disease
Intervention: Biological: Gardasil vaccine

  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
Location - Children’s Hospital Boston, including Waltham Infusion Center, and Maine Medical Center. Patients were recruited during a scheduled clinical or Remicade infusion visit, a hospital admission, by contact through mail followed by a phone call, or through referral from local hospitals. Recruitment period -April 2008 through April 2010

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Prospective Cohort Received Gardasil as part of study
Retrospective Cohort Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine

Participant Flow:   Overall Study
    Prospective Cohort     Retrospective Cohort  
STARTED     37     15  
COMPLETED     33     15  
NOT COMPLETED     4     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
Prospective Cohort Received Gardasil as part of study
Retrospective Cohort Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
Total Total of all reporting groups

Baseline Measures
    Prospective Cohort     Retrospective Cohort     Total  
Number of Participants  
[units: participants]
  37     15     52  
Age  
[units: participants]
     
<=18 years     33     6     39  
Between 18 and 65 years     4     9     13  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  14.9  ± 3.1     18.9  ± 3.5     16.1  ± 3.6  
Gender  
[units: participants]
     
Female     37     15     52  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     37     15     52  



  Outcome Measures
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1.  Primary:   Antibody Titer to HPV 6   [ Time Frame: Month 7 ]
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Measure Type Primary
Measure Title Antibody Titer to HPV 6
Measure Description No text entered.
Time Frame Month 7  
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 text entered.

Reporting Groups
  Description
Prospective Cohort Received Gardasil as part of study
Retrospective Cohort Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine

Measured Values
    Prospective Cohort     Retrospective Cohort  
Number of Participants Analyzed  
[units: participants]
  33     15  
Antibody Titer to HPV 6  
[units: milli-MerckĀ units/mL]
Geometric Mean ( 95% Confidence Interval )
  1079.9  
  ( 783 to 1489.3 )  
  173.4  
  ( 91.3 to 329.5 )  

No statistical analysis provided for Antibody Titer to HPV 6



2.  Primary:   Antibody Titer to HPV 11   [ Time Frame: Month 7 ]

3.  Primary:   Antibody Titers to HPV 16   [ Time Frame: Month 7 ]

4.  Primary:   Antibody Titer to HPV 18   [ Time Frame: Month 7 ]


  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
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