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Immune Response to the Human Papillomavirus Vaccine in Young Women With Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT01034358
Recruitment Status : Completed
First Posted : December 17, 2009
Results First Posted : October 23, 2012
Last Update Posted : October 23, 2012
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Mayo Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Inflammatory Bowel Disease
Uterine Cervical Dysplasia
Intervention Biological: Human Papillomavirus Vaccine
Enrollment 15
Recruitment Details Between March 2010 and January 2011, female patients between age 12-25 years of age were recruited through the Inflammatory Bowel Disease Clinics at the Mayo Clinic.
Pre-assignment Details  
Arm/Group Title Human Papillomavirus Vaccine
Hide Arm/Group Description The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
Period Title: Overall Study
Started 15
Completed 13 [1]
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Protocol Violation             1
[1]
One patient was found after enrollment to have already received one prior dose of the HPV vaccine.
Arm/Group Title Human Papillomavirus Vaccine
Hide Arm/Group Description The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
7
  46.7%
Between 18 and 65 years
8
  53.3%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
19.3  (3.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
15
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
Disease Activity at First HPV vaccine dose   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants
Quiescent 9
Active 6
[1]
Measure Description: Participants were categorized as either having quiescent (inactivity or dormancy) or active disease activity at baseline, prior to first HPV vaccine dose.
1.Primary Outcome
Title Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT])
Hide Description Anti-HPV levels were determined by an assay conducted by Merck & Co, Inc. and expressed as milliMerck units per milliliter (mMU/mL).
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Human Papillomavirus Vaccine
Hide Arm/Group Description:
The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
Overall Number of Participants Analyzed 13
Geometric Mean (95% Confidence Interval)
Unit of Measure: mMU/mL
HPV 6
120.5
(69.3 to 209.4)
HPV 11
175.0
(86.3 to 354.0)
HPV 16
861.0
(559.8 to 1321.3)
HPV 18
68.9
(34.9 to 135.5)
Time Frame Adverse events were collected over the 12 month period of the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Human Papillomavirus Vaccine
Hide Arm/Group Description The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
All-Cause Mortality
Human Papillomavirus Vaccine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Human Papillomavirus Vaccine
Affected / at Risk (%) # Events
Total   0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Human Papillomavirus Vaccine
Affected / at Risk (%) # Events
Total   13/15 (86.67%)    
Gastrointestinal disorders   
Nausea   4/15 (26.67%)  4
Abdominal Pain   1/15 (6.67%)  1
Sore Throat   1/15 (6.67%)  1
General disorders   
Malaise *  5/15 (33.33%)  5
Headache   6/15 (40.00%)  6
Lightheadedness   1/15 (6.67%)  1
Musculoskeletal and connective tissue disorders   
Myalgia   3/15 (20.00%)  3
Skin and subcutaneous tissue disorders   
Site reaction   11/15 (73.33%)  11
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeanne Tung, MD
Organization: Mayo Clinic
Phone: 507-266-0114
EMail: tung.jeanne@mayo.edu
Layout table for additonal information
Responsible Party: Jeanne Tung, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01034358     History of Changes
Other Study ID Numbers: 09-000485
First Submitted: December 10, 2009
First Posted: December 17, 2009
Results First Submitted: September 21, 2012
Results First Posted: October 23, 2012
Last Update Posted: October 23, 2012