Last updated on June 2018

Immunogenicity of Nonavalent HPV Vaccine Administered Prior to Renal Transplantation in Adult Women: A Prospective Single-Arm Multi-Center Clinical Trial


Brief description of study

This trial studies whether the nonavalent human papillomavirus vaccine given to adult women prior to kidney transplantation can help the body build and maintain an effective immune response during the post-transplant period when they receive immunosuppressive drugs to prevent transplant rejection. This study will help inform our scientific understanding about vaccine-induced immune responses among immunosuppressed individuals.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To assess human papillomavirus (HPV) vaccine-type-specific seroconversion rates at 12-months post-transplantation among kidney transplant recipients who receive >= 1 doses of the recombinant human papillomavirus nonavalent vaccine (Gardasil 9 HPV vaccine) >= 30 days prior to transplantation.

SECONDARY OBJECTIVES:

I. To evaluate the following in female kidney transplant recipients who receive >= 1 doses of the Gardasil 9 HPV vaccine prior to transplantation: HPV vaccine-type-specific seroconversion rates at 12-months post-transplantation stratified by: a) number of doses (1, 2, or 3) of the vaccine given pre-transplant; b) time elapsed between last vaccine dose and the transplant procedure; c) variations in dosing and types of post-transplant immunosuppressant medications; and interactions with type of transplant surgery (living donor/deceased donor), and d) differences in human leukocyte antigen (HLA) histocompatibility between donor and recipient.

II. To evaluate the following in female kidney transplant recipients who receive >= 1 doses of the Gardasil 9 HPV vaccine >= 30 days prior to transplantation: persistence and stability of HPV vaccine-type-specific geometric mean titers (GMT) at 6 and 12-months post-transplantation, and rise in HPV vaccine-type-specific GMT at the 13 month post-transplant visit.

III. To evaluate the following in female kidney transplant recipients who receive >= 1 doses of the Gardasil 9 HPV vaccine >= 30 days prior to transplantation: vaccine safety profile and allograft rejection/opportunistic infections stratified by number of vaccine doses and time between the last vaccine dose and the transplant procedure.

IV. To evaluate the following in female kidney transplant recipients who receive >= 1 doses of the Gardasil 9 HPV vaccine >= 30 days prior to transplantation: HPV detection in samples from the cervix/vagina, and oral cavity at baseline (pre-vaccination) and at 6- and 12-months post-vaccination, overall and by number of vaccine doses (1, 2, or 3), sexual behavior, type-specific seroconversion rates, and time elapsed between the last vaccine dose and the transplant procedure.

OUTLINE

Participants receive the first dose of the recombinant human papillomavirus nonavalent vaccine IM at baseline, at least 30 days prior to the kidney transplant surgery. The second dose is given at least one month after the first dose. The third dose is given at least five months after the first dose and at least three months after the second dose. The timing of the second and third doses is dependent on the scheduling of the kidney transplant surgery. Participants are followed up at 6- and 12-months after the kidney transplant surgery to measure vaccine-induced immune responses. Participants may receive either one, two, or all three vaccine doses prior to the kidney transplant surgery, and are offered additional visits at least one year after the surgery to complete any remaining doses of the three-dose vaccine series.

Clinical Study Identifier: NCT03036930

Contact Investigators or Research Sites near you

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E. T. Overton

University of Alabama at Birmingham Cancer Center
Birmingham, AL United States
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Irene Kim

Cedars Sinai Medical Center
Los Angeles, CA United States
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Garrett R. Roll

UCSF Medical Center-Mount Zion
San Francisco, CA United States
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Michael Ison

Northwestern University
Chicago, IL United States
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Raymund R. Razonable

Mayo Clinic
Rochester, MN United States
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