Last updated on April 2020

Preventive Human Papillomavirus (HPV) Vaccine Trial in Kidney Transplant Recipients


Brief description of study

This trial studies whether the nonavalent human papillomavirus vaccine given to adults 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 adult kidney transplant recipients who receive >= 1 doses of the Gardasil 9 HPV vaccine prior to transplantation:

Ia. HPV vaccine-type-specific seroconversion rates at 12-months post-transplantation.

Ib. 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.

Ic. 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.

Id. HPV detection in self-collected 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.

Ie. Descriptive analysis to explore differences or similarities between the genders from the secondary objective outcomes above.

OUTLINE

Participants receive the first dose of the recombinant human papillomavirus nonavalent vaccine intramuscularly (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. Patients are followed up at 6- and 12-months after the kidney transplant surgery to measure vaccine-induced immune responses. Patients 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

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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