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Vaccine

HPV Vaccine for Post-Kidney Transplant Recipients

Phase 2

Waitlist Available

Led By Marc T Goodman

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 and 12 months post-transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at whether a HPV vaccine can help the body build an effective immune response post-kidney transplant when immunosuppressive drugs are given to prevent transplant rejection.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While specific side effects aren't listed here, common reactions to vaccines like Gardasil 9 may include pain at injection site, swelling, redness, headaches, fatigue and nausea. Severe allergic reactions are rare but possible.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ self-collected at baseline (pre-vaccination) and at 6- and 12- months post-vaccination

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~self-collected at baseline (pre-vaccination) and at 6- and 12- months post-vaccination

This trial's timeline: 3 weeks for screening, Varies for treatment, and self-collected at baseline (pre-vaccination) and at 6- and 12- months post-vaccination for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Human papillomavirus

Secondary study objectives

HPV vaccine-type-specific seroconversion rates

Other study objectives

Cervix Uteri

Probability of seroconversion

Rise in HPV vaccine-type-specific GMT

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HPV Self-Collection

2021

N/A

~820

Biospecimen Collection

2004

Completed Phase 3

~2030