A Phase 4 interventional study of Human Papillomavirus Vaccine in Inflammatory Bowel Disease and Uterine Cervical Dysplasia, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to female participants aged 9 Years to 26 Years. Per ClinicalTrials.gov, last updated 2012-10-23.
Sponsored by Mayo Clinic · Phase 4, Interventional, and Prevention
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.
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.
356 studies on the registry are indexed under Uterine Cervical Dysplasia; 68 are open to participants now.
This study's enrollment of 15 is below the median of 166 across 249 interventional studies indexed under Uterine Cervical Dysplasia.
Browse Uterine Cervical Dysplasia studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
Biological: Human Papillomavirus Vaccine
0.5mL intramuscular for 3 doses at 0, 2, and 6 months
Also known as: Gardasil
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
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.
| Milestone | Human Papillomavirus Vaccine |
|---|---|
| Started | 15 |
| Completed | 13 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Protocol violation | 1 |
Anti-HPV levels were determined by an assay conducted by Merck \& Co, Inc. and expressed as milliMerck units per milliliter (mMU/mL).
| mMU/mL | Human Papillomavirus Vaccine |
|---|---|
| HPV 6 | 120.5 (69.3 to 209.4) |
| HPV 11 | 175.0 (86.3 to 354.0) |
| HPV 16 | 861.0 (559.8 to 1321.3) |
| HPV 18 | 68.9 (34.9 to 135.5) |
Collected over Adverse events were collected over the 12 month period of the study.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Human Papillomavirus Vaccine | — | 0/15 (0%) | 13/15 (86.7%) |
| Event | Human Papillomavirus Vaccine |
|---|---|
| Site reactionSkin and subcutaneous tissue disorders | 11/15 |
| HeadacheGeneral disorders | 6/15 |
| MalaiseGeneral disorders | 5/15 |
| NauseaGastrointestinal disorders | 4/15 |
| MyalgiaMusculoskeletal and connective tissue disorders | 3/15 |
| Abdominal PainGastrointestinal disorders | 1/15 |
| LightheadednessGeneral disorders | 1/15 |
| Sore ThroatGastrointestinal disorders | 1/15 |
| Age, Categorical(Participants) | Human Papillomavirus Vaccine |
|---|---|
| <=18 years | 7 |
| Between 18 and 65 years | 8 |
| >=65 years | 0 |
| Age Continuous(years) | Human Papillomavirus Vaccine |
|---|---|
| Mean | 19.3 ± 3.68 |
| Sex: Female, Male(Participants) | Human Papillomavirus Vaccine |
|---|---|
| Female | 15 |
| Male | 0 |
| Region of Enrollment(participants) | Human Papillomavirus Vaccine |
|---|---|
| United States | 15 |
| Disease Activity at First HPV vaccine dose(participants) | Human Papillomavirus Vaccine |
|---|---|
| Quiescent | 9 |
| Active | 6 |
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mayo Clinic