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

Human Papillomavirus Infection Clinical Trial

Official title: Immunogenicity of Nonavalent HPV Vaccine Administered Prior to Renal Transplantation in Adults: A Prospective, Single-Arm, Multi-Center Clinical Trial

Status Active, not recruiting

Clinical Trial Summary

This phase II 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.

Clinical Trial Description

PRIMARY OBJECTIVE:

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 [registered trademark] 9 HPV vaccine) >= 30 days prior to transplantation.

SECONDARY OBJECTIVE:

I. To assess HPV vaccine-type-specific seroconversion rates at 6- and 12-months post-transplantation stratified by number of doses (1, 2, or 3) of the vaccine given pre-transplant among kidney transplant recipients who receive >= 1 doses of the Gardasil 9 HPV vaccine prior to transplantation.

EXPLORATORY OBJECTIVES:

I. To assess the following among kidney transplant recipients who receive >= 1 doses of the Gardasil 9 HPV vaccine >= 30 days prior to transplantation:

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

Ii. Time elapsed between last vaccine dose and the transplant procedure; Iii. Variations in dosing and types of post-transplant immunosuppressant medications; and interactions with type of transplant surgery (living donor/deceased donor); Iiii. Differences in human leukocyte antigen (HLA) histocompatibility between donor and recipient; Iiv. Differences in biological sex (i.e. male versus [vs.] female) of the transplant recipient; Ib. 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 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 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. Patients also undergo collection of blood samples and self-collection of cervical/vaginal samples (female participants only) on study. ;

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Papillomavirus Infections

• NCT number: NCT03036930
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 23, 2017
• Completion date: March 4, 2025