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Summary

for females ages 18–49 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

This phase II trial studies how well recombinant human papillomavirus nonavalent vaccine works in preventing human papillomavirus-related cancer in adult women after kidney transplant. Vaccines made from peptides of human papillomavirus may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer.

Official Title

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

Details

PRIMARY OBJECTIVES:

  1. To assess human papillomavirus (HPV) vaccine-type-specific seroconversion rates at 12-months post-transplantation among female living donor 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 living donor kidney transplant recipients who receive >= 1 doses of the Gardasil 9 HPV vaccine >= 30 days prior to transplantation: HPV vaccine-type-specific seroconversion rates at 12-months post-transplantation stratified by: a) number of doses (1 versus [vs.] 2) 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 d) differences in human leukocyte antigen (HLA) histocompatibility between donor and recipient.

II. To evaluate the following in female living donor 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-months posttransplantation visit (1-month after the third/booster vaccine dose).

III. To evaluate the following in female living donor 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 living donor 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 vs. 2), sexual behavior, type-specific seroconversion rates, and time elapsed between the last vaccine dose and the transplant procedure.

OUTLINE:

Patients receive recombinant human papillomavirus nonavalent vaccine intramuscularly (IM) at baseline and approximately 30 days after first dose. Patients then receive a booster 12 months after kidney transplant.

Keywords

Solid Organ Transplantation Recipient Vaccines

Eligibility

You can join if…

Open to females ages 18–49

  • Female candidate for living donor renal transplant within 24 months of enrollment
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
  • Leukocytes >= 3,000/microliter
  • Absolute neutrophil count >= 1,500/microliter
  • Platelets >= 75,000/microliter
  • Total bilirubin =< 2 x institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])=< 3 x institutional ULN
  • ABO compatible with donor
  • Panel reactive antibody (PRA) < 80%
  • Women who are able to become pregnant must have a confirmed negative pregnancy test result 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
  • 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
  • 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; pregnant women are excluded from this study
  • 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
September 29, 2017
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