Phase 4 N=15 Prevention

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

Inflammatory Bowel Disease · Uterine Cervical Dysplasia

Bottom Line

View on ClinicalTrials.gov: NCT01034358 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2012

Primary outcome: Primary: Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT]) — 120.5; 175.0; 861.0; 68.9 mMU/mL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Human Papillomavirus Vaccine (Biological)
Age: Pediatric, Adult · 9+ yrs
Sex: Female
Sponsor: Mayo Clinic
Primary completion: Jun 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT])	120.5; 175.0; 861.0; 68.9	—

Summary

The Gardasil vaccine, a vaccine targeted towards the human papillomavirus (HPV), has been shown to prevent the transmission of several strains of HPV in young women. Women with inflammatory bowel disease (IBD) may not respond as well to this vaccine, either due to having IBD or due to immunosuppressants used to control IBD. This study will test how well women with IBD respond to the Gardasil vaccine.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01034358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.