Immunogenicity of HPV Vaccine in Transplant Recipients.

Chronic Kidney Diseases Clinical Trial

Official title: Prospective Analysis of Immunogenicity of the Nonavalent Human Papillomavirus Vaccination (GARDASIL 9) in Patients Pre and Post Solid Organ Transplant

Status Recruiting

Clinical Trial Summary

To measure levels of HPV antibodies in pre-renal organ transplant and renal transplant recipients who have gotten the HPV9 vaccine and compare to control antibody levels.

Clinical Trial Description

This is a prospective open-label nonrandomized single-center cohort study aimed to analyze the immunogenicity of nanovalent human papillomavirus vaccination (GARDASIL 9) in patients pre and post solid organ transplant.

The study duration is anticipated to be 36 months. The expected duration of subject participation is 24 months. Immunocompromised populations are at greater risk of HPV infection. Quadrivalent HPV vaccination has been performed and lower titers of antibodies have been compared to published date in non-immunocompromised population (controls). The HPV9 vaccination titers have not been measured in the immunocompromised population to date.

Group 1 (50 patients): Adult patients listed for renal transplant ages 18-45 will be enrolled in the outpatient transplant and nephrology clinic at the Medical College of Wisconsin - Froedtert Memorial Lutheran Hospital. Group 2: (50 patients): Adult renal transplant recipients ages 18 -45 years > 6 months from transplant will be candidates for participation in the outpatient transplant and nephrology clinics at the Medical College of Wisconsin - Froedtert Memorial Lutheran Hospital.

Patients will be scheduled to receive 3-dose 9vHPV vaccination (vaccination at enrollment [time 0], 2 months [+ 6 weeks], and 6 months [+ 6 weeks] per standard guidelines) prior to renal transplantation for one cohort (Group 1) and after renal transplant in the second cohort (Group 2). Serial serum samples will be obtained for geometric mean titers (GMT) prior to vaccination, at 7 months (+ 6 weeks), 12 months (+ 6 weeks), and 24 months (+ 6 weeks) after completion of the vaccination series. If a patient is subsequently scheduled to undergo a transplant, we will obtain the GMT prior to the transplant.

Subjects will be asked to consent to optional banking of whole-blood for future research and translational studies. Blood will be stored in the Obstetrics & Gynecology Specimen and Data Bank (PRO 11631) at Medical College of Wisconsin.

If subjects chose to participate in the optional banking of their blood, approximately 5 mls of additional blood will be drawn prior to vaccination and at the time of the 7, 12, and 24- month GMT blood draws.

Anti-HPV antibody responses will be measured using a proprietary MERCK Competitive Luminex Immunoassay (cLIA) which will be performed by Merck and expressed as geometric mean titers (GMT). ;

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Kidney Transplant
• Renal Insufficiency, Chronic

• NCT number: NCT05557370
• Study type: Interventional
• Source: Medical College of Wisconsin
• Contact: Subarna Paul
• Phone: (414) 805-8594
• Email: supaul@mcw.edu
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2023
• Completion date: December 31, 2035