- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01034358
Immune Response to the Human Papillomavirus Vaccine in Young Women With Inflammatory Bowel Disease
Comparison of Immune Response to the Human Papillomavirus Vaccine in Young Women With and Without Inflammatory Bowel Disease
Study Overview
Status
Intervention / Treatment
Detailed Description
Although guidelines exist for immunization of patients with inflammatory bowel disease, few studies exist demonstrating vaccine efficacy in this population. In patients with inflammatory bowel disease, lower than normal humoral responses have been shown with the tetanus toxoid booster, oral cholera, and influenza vaccinations. It is currently uncertain whether women with inflammatory bowel disease (IBD) have an increased risk of cervical dysplasia and cancer. Gardasil, a vaccine against human papilloma viruses (HPV) 6, 11, 16, and 18, has been approved for the prevention of cervical dysplasias and cancers in women ages 9-26 years. However, its immune response in immunocompromised or immunosuppressed patients is unknown.
Young women with inflammatory bowel disease who have not received the HPV vaccine will receive the vaccine. The vaccine is given in 3 doses over 6 months. Response to the vaccine will be measured 6 months after completing the vaccine series.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women 9-26 years of age
- Have inflammatory bowel disease (ie. Crohns disease or ulcerative colitis)
Exclusion Criteria:
- Pregnancy
- Taking corticosteroids
- Allergy to yeast aluminum component of the HPV vaccine
- Positive for all HPV types in the Gardasil vaccine-6, 11, 16, 18
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Human Papillomavirus Vaccine
The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
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0.5mL intramuscular for 3 doses at 0, 2, and 6 months
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT])
Time Frame: One year
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Anti-HPV levels were determined by an assay conducted by Merck & Co, Inc. and expressed as milliMerck units per milliliter (mMU/mL).
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One year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeanne Tung, MD, Mayo Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Uterine Cervical Diseases
- Uterine Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Precancerous Conditions
- Carcinoma in Situ
- Cervical Intraepithelial Neoplasia
- Inflammatory Bowel Diseases
- Intestinal Diseases
- Uterine Cervical Dysplasia
Other Study ID Numbers
- 09-000485
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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