NCT05557370

Immunogenicity of HPV Vaccine in Transplant Recipients.

Prospective Analysis of Immunogenicity of the Nonavalent Human Papillomavirus Vaccination (GARDASIL 9) in Patients Post Solid Organ Transplant

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

To measure levels of HPV antibodies in post-solid-organ transplant recipients who have gotten the HPV9 vaccine.

Detailed 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 post-solid-organ transplant patients. 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. We plan to enroll 30 adult solid-organ transplant recipients ages 18-45 years \>6 months from transplant receiving treatment at clinics at F\&MCW Main Campus. 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). 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).

Conditions

• Chronic Kidney Diseases
• Kidney Transplant

Interventions

Type	Name	Description
BIOLOGICAL	Human Papilloma Virus vaccine (GARDASIL 9)	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).

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-12-31
• Completion: 2035-12-31
• First posted: 2022-09-28
• Last updated: 2025-07-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study