Summary

for females ages 18-49 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Garrett R. Roll

Description

Summary

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.

Details

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Keywords

Kidney Transplantation Vaccines Laboratory Biomarker Analysis Questionnaire Administration Recombinant Human Papillomavirus Nonavalent Vaccine Prevention (Gardasil 9 HPV vaccine)

Eligibility

You can join if…

Open to females ages 18-49

  • Female candidate for renal transplant, expected to undergo transplant surgery >= 30 days and =< 12 months after enrollment
  • For potential participants on the institutional waiting list for deceased donor transplant, a study clinician confirms the candidate is likely to receive a transplant within the next 12 months, taking into account the candidate's priority on the waiting list, age, medical status, institutional policies, and scores like the Estimated Post-Transplant Survival (EPTS) Score and Calculated Panel Reactive Antibody (CPRA) percentage, etc
  • For potential participants expected to undergo a living donor transplant, one or more donor(s) have been identified and is/are in work-up (even though all work-up status may or may not be complete); a study clinician confirms the living donor transplant is likely to be scheduled within the next twelve months after taking into account donor work-up progress, age and medical status, and institutional policies
  • Note: the study was originally restricted to participants who were expecting to receive only living donor renal transplants; however, less than a third of kidney transplants in the United States occur with kidneys from living donors; a majority of transplants are in the setting of donation of kidneys from deceased donors; to permit efficiencies in accrual, the study is amended to also open enrollment to recipients of deceased donor kidneys
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
  • Women who are able to become pregnant must have a confirmed negative pregnancy test result within the past 28 days prior to enrollment and must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately; women who have had a both ovaries removed or a tubal ligation will not be required to have a pregnancy test
  • Ability to understand and the willingness to sign a written informed consent document and medical release form
  • Willing and able to comply with trial protocol and follow-up

You CAN'T join if...

  • Previous prophylactic HPV vaccination
  • Prior organ transplant
  • Anticipated desensitization treatment; this decision to exclude will be based on the site clinician's judgement; desensitization procedures vary somewhat among the five participating transplant centers, which does not permit proposing uniform criteria across all study sites for determining exclusion due to desensitization; in general,women who have received a prior transplant, have unsuitable scores on Calculated Panel Reactive Antibody (PRA) percentage (institution-specific thresholds), or an ABO incompatible donor are likely to undergo desensitization at one or more of the study centers; these factors, among others, will be used by the study clinician to determine exclusion due to anticipated desensitization in the study
  • Current use of any other investigational agents
  • History of allergic reactions to yeast or attributed to compounds of similar chemical or biologic composition to Gardasil 9 HPV vaccine
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant or intention to get pregnant, or breastfeeding; pregnant women are excluded from this study; women who are breastfeeding will be excluded
  • Carcinoma in situ (CIS) of the cervix or history of cervical cancer
  • History of active malignancy, including basal/squamous cell skin cancer
  • Prior hysterectomy
  • Concurrent illness, such as known psychiatric disorders or substance abuse (i.e.,average alcohol consumption of more than 3 drinks per day), which in the opinion of the investigators would compromise either the patient or the integrity of the data
  • Patients on anticoagulation or with bleeding disorders should be evaluated by a physician for risk/benefit of bleeding disorders with intramuscular injections prior to study enrollment; patients determined to be at high risk for bleeding with intramuscular injections will be excluded

Locations

  • UCSF Medical Center-Mount Zion accepting new patients
    San Francisco California 94115 United States
  • Cedars Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Cancer Institute (NCI)
ID
NCT03036930
Phase
Phase 2
Lead Scientist
Garrett R. Roll
Study Type
Interventional
Last Updated