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OpenTrials
Completed

NCT Number: NCT01034358

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

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.

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Key information

Conditions

Inflammatory Bowel Disease Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Genital Diseases Genital Diseases, Female Inflammatory Bowel Diseases Intestinal Diseases Neoplasms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases

Age range

9 year–26 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Human Papillomavirus vaccine

Biological

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

Other names: Gardasil

Primary outcomes

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

    Time frame: One year

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Comparison of Immune Response to the Human Papillomavirus Vaccine in Young Women With and Without Inflammatory Bowel Disease

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 17, 2009
Registry last updated
Oct 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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