Immunogenicity of HPV Vaccine in Transplant Recipients.

NCT ID: NCT05557370

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2035-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Human Papilloma Virus vaccine (GARDASIL 9)

Intervention Type: BIOLOGICAL

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).

Interventions

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).

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Denise Uyar

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Denise Uyar, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin/ Froedtert Hospital

Locations

Froedtert Lutheran Memorial Hospital

Milwaukee, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

HPV MK-MISP 61451

Identifier Type: -

Identifier Source: org_study_id