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

NCT01034358 | Completed Phase 4 Results

• 1 other identifier: 09-000485
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Disease; Uterine Cervical Dysplasia

Keywords

inflammatory bowel disease; Crohn disease; ulcerative colitis; Papillomavirus vaccines

Outcome Measures

Primary Outcomes (1)

• Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT])

  Anti-HPV levels were determined by an assay conducted by Merck \& Co, Inc. and expressed as milliMerck units per milliliter (mMU/mL).

  One year

Study Arms (1)

Human Papillomavirus Vaccine

EXPERIMENTAL

The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.

Biological: Human Papillomavirus Vaccine

Interventions

Human Papillomavirus Vaccine BIOLOGICAL

0.5mL intramuscular for 3 doses at 0, 2, and 6 months

Also known as: Gardasil

Human Papillomavirus Vaccine

Eligibility Criteria

• Age: 9 Years - 26 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women 9-26 years of age
• Have inflammatory bowel disease (ie. Crohns disease or ulcerative colitis)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Uterine Cervical Dysplasia; Crohn Disease; Colitis, Ulcerative

Interventions

Papillomavirus Vaccines; Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Results Point of Contact

• Title: Jeanne Tung, MD
• Organization: Mayo Clinic

tung.jeanne@mayo.edu

507-266-0114

Study Officials

• Jeanne Tung, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 17, 2009
• Study Start: February 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 23, 2012
• Results First Posted: October 23, 2012

Record last verified: 2012-09

Locations

US (1)