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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Kidney Diseases; Kidney Transplant
• Intervention / Treatment: Biological: Human Papilloma Virus vaccine (GARDASIL 9)

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).

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Lutheran Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Study Population

patients who are < age 45 and pre renal transplant or > 6 months post transplant

Description

Inclusion Criteria:

1. Patient between the age of 18 and 45 years
2. Patient is at least 6 months post-solid-organ transplant and has not received GARDASIL 9.
3. Patient who can participate in their health care and sign informed consent.
4. Patient may have had bivalent or quadrivalent HPV vaccination previously.

5. Living or deceased donor transplant patient is eligible.

   Exclusion Criteria:

6. Contraindication: Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of GARDASIL 9 or GARDASIL.
7. Patient had completed vaccination series with a nonavalent HPV vaccine (e.g., GARDASIL 9) in the past
8. Patient with a diagnosis of HIV.
9. Patient that endorses being currently pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional; Patient between the age of 18 and 45 years with at least 6 months post-solid-organ transplant who has not received GARDASIL 9.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome	The primary outcome is to measure immunogenicity using the Merck proprietary Competitive Luminex Immunoassay (cLIA) and geometric mean titers (GMTs) over specified time intervals (7 months, 12 months and 24 months from vaccination) in patients to each of the nine human papillomavirus types contained in the nanovalent human papillomavirus vaccine (HPV9) vaccination and compare these antibody levels to published control data for non-immunocompromised individuals. this has been completed previously for the quadrivalent HPV vaccination series but no data exists for the HPV9 vaccination in this population. We will also compare GMTs in our study patients and over time to determine if there is a difference between timing of vaccine administration.	7 months, 12 months and 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome	Immunogenicity using the Merck proprietary Competitive Luminex Immunoassay (cLIA) and geometric mean titers (GMTs) over specified time intervals (7 months, 12 months and 24 months from vaccination) in a patient cohort prior to kidney. We will assess the change in GMT over time. The utilization of regression analysis to determine the effect of variables on antibody response (GMTs) such as age, gender, race, renal function and type of immunosuppression, and donor type.	7 months, 12 months and 24 months

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Denise Uyar, MD, Medical College of Wisconsin/ Froedtert Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2035

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Biological Products; Complex Mixtures; Vaccines; Viral Vaccines; Human Papillomavirus Recombinant Vaccine nonavalent; Papillomavirus Vaccines
• Other Study ID Numbers: HPV MK-MISP 61451

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes