Inflammatory Bowel Disease, Uterine Cervical Dysplasia
Conditions
Keywords
inflammatory bowel disease, Crohn disease, ulcerative colitis, Papillomavirus vaccines
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.
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.
Interventions
BIOLOGICALHuman Papillomavirus Vaccine
0.5mL intramuscular for 3 doses at 0, 2, and 6 months
Sponsors
Merck Sharp & Dohme LLC
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
9 Years to 26 Years
Healthy volunteers
No
Inclusion criteria
1. Women 9-26 years of age 2. Have inflammatory bowel disease (ie. Crohns disease or ulcerative colitis)
Exclusion criteria
1. Pregnancy 2. Taking corticosteroids 3. Allergy to yeast aluminum component of the HPV vaccine 4. Positive for all HPV types in the Gardasil vaccine-6, 11, 16, 18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT]) | One year | Anti-HPV levels were determined by an assay conducted by Merck & Co, Inc. and expressed as milliMerck units per milliliter (mMU/mL). |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Human Papillomavirus Vaccine The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months. | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Human Papillomavirus Vaccine |
|---|---|
| Age, Categorical <=18 years | 7 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age Continuous | 19.3 years STANDARD_DEVIATION 3.68 |
| Disease Activity at First HPV vaccine dose Active | 6 participants |
| Disease Activity at First HPV vaccine dose Quiescent | 9 participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 13 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
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).
Time frame: One year
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Human Papillomavirus Vaccine | Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT]) | HPV 6 | 120.5 mMU/mL |
| Human Papillomavirus Vaccine | Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT]) | HPV 11 | 175.0 mMU/mL |
| Human Papillomavirus Vaccine | Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT]) | HPV 16 | 861.0 mMU/mL |
| Human Papillomavirus Vaccine | Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT]) | HPV 18 | 68.9 mMU/mL |