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

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

History of Changes

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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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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2. Primary:

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

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3. Primary:

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

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Measure Type	Primary
Measure Title	Antibody Titers to HPV 16
Measure Description	Geometric mean titer (95% CI)
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.
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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

Measured Values

	Prospective Cohort	Retrospective Cohort
Number of Participants Analyzed [units: participants]	33	15
Antibody Titers to HPV 16 [units: milli-Merck units/mL] Geometric Mean ( 95% Confidence Interval )	3975.1 ( 2492.2 to 6340.6 )	802.7 ( 391.1 to 1676.6 )

No statistical analysis provided for Antibody Titers to HPV 16

4. Primary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	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
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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

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