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
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

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 ]

2.  Primary:   Antibody Titer to HPV 11   [ Time Frame: Month 7 ]
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Measure Type Primary
Measure Title Antibody Titer to HPV 11
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.
Number of participants who completed all vaccine doses

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 11  
[units: milli-MerckĀ units/mL]
Geometric Mean ( 95% Confidence Interval )
  1681.8  
  ( 1189.9 to 2377.2 )  
  267.3  
  ( 122.4 to 583.8 )  

No statistical analysis provided for Antibody Titer to HPV 11



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


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Athos Bousvaros
Organization: Children's Hospital Boston
phone: 617-355-2962
e-mail: athos.bousvaros@childrens.harvard.edu


No publications provided


Responsible Party: Athos Bousvaros, MD, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00727636     History of Changes
Other Study ID Numbers: 07-09-0344
Study First Received: July 31, 2008
Results First Received: May 3, 2011
Last Updated: May 3, 2011
Health Authority: United States: Institutional Review Board