HPV Vaccine for Post-Kidney Transplant Recipients

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byMarc T Goodman

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Marc T Goodman

Principal Investigator

Northwestern University

Eligibility Criteria

Adults aged 18-49 who are candidates for kidney transplant surgery within the next year, have a good performance status (able to carry out daily activities), and can give informed consent. It's open to both genders, but not for those with active cancer, previous HPV vaccination, prior organ transplants, yeast allergies, or certain uncontrolled illnesses. Pregnant or breastfeeding women and those planning pregnancy are excluded.

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

Candidate for renal transplant, expected to undergo transplant surgery >= 30 days and =< 12 months after enrollment

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

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Exclusion Criteria

You have had a type of cancer called basal/squamous cell skin cancer in the past.

You are currently taking any experimental medications.

Previous prophylactic HPV vaccination

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Treatment Details

Interventions

Recombinant Human Papillomavirus Nonavalent Vaccine (Vaccine)

Trial OverviewThe trial is testing if the nonavalent HPV vaccine can help adults build a strong immune response before kidney transplantation and maintain it while on immunosuppressive drugs post-transplant. Participants will receive the vaccine along with biospecimen collection, self-collected HPV samples, and questionnaires.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Prevention (Gardasil 9 HPV vaccine)Experimental Treatment4 Interventions

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. 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.