Trial Outcomes & Findings for Immune Response to the Human Papillomavirus Vaccine in Young Women With Inflammatory Bowel Disease (NCT NCT01034358)

NCT ID: NCT01034358

Last Updated: 2012-10-23

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 15 participants
• Primary outcome timeframe: One year
• Results posted on: 2012-10-23

Participant Flow

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.

Participant milestones

Measure	Human Papillomavirus Vaccine The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
Overall Study STARTED	15
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Human Papillomavirus Vaccine The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
Overall Study Withdrawal by Subject	1
Overall Study Protocol Violation	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Human Papillomavirus Vaccine n=15 Participants The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
Age, Categorical <=18 years	7 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	19.3 years STANDARD_DEVIATION 3.68 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
Disease Activity at First HPV vaccine dose Quiescent	9 participants n=5 Participants
Disease Activity at First HPV vaccine dose Active	6 participants n=5 Participants

PRIMARY outcome

Timeframe: One year

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

Outcome measures

Measure	Human Papillomavirus Vaccine n=13 Participants The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT]) HPV 6	120.5 mMU/mL Interval 69.3 to 209.4
Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT]) HPV 11	175.0 mMU/mL Interval 86.3 to 354.0
Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT]) HPV 16	861.0 mMU/mL Interval 559.8 to 1321.3
Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT]) HPV 18	68.9 mMU/mL Interval 34.9 to 135.5

Adverse Events

Human Papillomavirus Vaccine

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Human Papillomavirus Vaccine n=15 participants at risk The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
Skin and subcutaneous tissue disorders Site reaction	73.3% 11/15 • Number of events 11 • Adverse events were collected over the 12 month period of the study.
General disorders Malaise	33.3% 5/15 • Number of events 5 • Adverse events were collected over the 12 month period of the study.
General disorders Headache	40.0% 6/15 • Number of events 6 • Adverse events were collected over the 12 month period of the study.
Gastrointestinal disorders Nausea	26.7% 4/15 • Number of events 4 • Adverse events were collected over the 12 month period of the study.
Gastrointestinal disorders Abdominal Pain	6.7% 1/15 • Number of events 1 • Adverse events were collected over the 12 month period of the study.
Musculoskeletal and connective tissue disorders Myalgia	20.0% 3/15 • Number of events 3 • Adverse events were collected over the 12 month period of the study.
General disorders Lightheadedness	6.7% 1/15 • Number of events 1 • Adverse events were collected over the 12 month period of the study.
Gastrointestinal disorders Sore Throat	6.7% 1/15 • Number of events 1 • Adverse events were collected over the 12 month period of the study.

Additional Information

Jeanne Tung, MD

Mayo Clinic

Phone: 507-266-0114

Email: tung.jeanne@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place