Trial Outcomes & Findings for Does the HPV Vaccine Cause the Same Response in Adolescent Kidney and Liver Transplant Patients as in Healthy Controls? (NCT NCT01101750)

NCT ID: NCT01101750

Last Updated: 2021-01-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 25 participants
• Primary outcome timeframe: 7 months
• Results posted on: 2021-01-05

Participant Flow

Participant milestones

Measure	Liver and Kidney Transplant Arm Standard of Care Intervention: Participants on this arm receive Gardasil vaccine and have a history of liver or kidney transplant. Biological/Vaccine: Quadrivalent HPV for types 6, 11, 16 and 18 Per standard of care, Gardasil 0.5ml IM injection on day one, month 2, and month 6. Serum samples on day one, month 3 and month 7.
Overall Study STARTED	25
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Does the HPV Vaccine Cause the Same Response in Adolescent Kidney and Liver Transplant Patients as in Healthy Controls?

Baseline characteristics by cohort

Measure	Liver and Kidney Transplant Patient Arm n=25 Participants Standard of Care Intervention: Participants on this arm receive Gardasil vaccine and have a history of liver or kidney transplant. Biological/Vaccine: Quadrivalent HPV for types 6, 11, 16 and 18 Per standard of care, Gardasil 0.5ml IM injection on day one, month 2, and month 6. Serum samples on day one, month 3 and month 7.
Age, Continuous	15 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 months

Population: 9 of 25 patients completed the full study (three vaccinations and blood draws). Incomplete data was collected for the remaining 16 subjects.

Outcome measures

Measure	Liver and Kidney Transplant Patient Arm n=9 Participants Standard of Care Intervention: Participants on this arm receive Gardisil vaccine and have a history of liver transplant. Biological/Vaccine: Quadrivalent HPV for types 6, 11, 16 and 18 Per standard of care, Gardasil 0.5ml IM injection on day one, month 2, and month 6. Serum samples on day one, month 3 and month 7.
Number of Subjects Showing Seroconversion to All HPV Four Serotypes	9 Participants

Adverse Events

Liver and Kidney Transplant Arm

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Liver and Kidney Transplant Arm n=25 participants at risk Standard of Care Intervention: Participants on this arm receive Gardasil vaccine and have a history of liver or kidney transplant. Biological/Vaccine: Quadrivalent HPV for types 6, 11, 16 and 18 Per standard of care, Gardasil 0.5ml IM injection on day one, month 2, and month 6. Serum samples on day one, month 3 and month 7.
Renal and urinary disorders Acute graft rejection	8.0% 2/25 • Number of events 2
Renal and urinary disorders High grade fever	4.0% 1/25 • Number of events 1

Other adverse events

Measure	Liver and Kidney Transplant Arm n=25 participants at risk Standard of Care Intervention: Participants on this arm receive Gardasil vaccine and have a history of liver or kidney transplant. Biological/Vaccine: Quadrivalent HPV for types 6, 11, 16 and 18 Per standard of care, Gardasil 0.5ml IM injection on day one, month 2, and month 6. Serum samples on day one, month 3 and month 7.
Renal and urinary disorders Fever	12.0% 3/25
Renal and urinary disorders Facial Acne	4.0% 1/25
Renal and urinary disorders Swelling and Pain at the Injection Site	12.0% 3/25
Renal and urinary disorders Cough	4.0% 1/25
Renal and urinary disorders Pneumonia	4.0% 1/25
Renal and urinary disorders Diarrhea	4.0% 1/25
Renal and urinary disorders Headache	4.0% 1/25

Additional Information

Veronica Gomez-Lobo, MD

MedStar Health Research Institute

Phone: 202-877-4099

Email: veronica.gomez-lobo@medstar.net

Results disclosure agreements

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