Immunogenicity of HPV Vaccine in Transplant Recipients.

NCT05557370 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: HPV MK-MISP 61451
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Kidney Diseases; Kidney Transplant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary Outcome

  7 months, 12 months and 24 months

Study Arms (1)

Interventional

EXPERIMENTAL

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)

Interventions

Human Papilloma Virus vaccine (GARDASIL 9) 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).

Interventional

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Froedtert Lutheran Memorial Hospital

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Papillomavirus Vaccines; Human Papillomavirus Recombinant Vaccine nonavalent

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Denise Uyar, MD

  Medical College of Wisconsin/ Froedtert Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 28, 2022
• Study Start: June 1, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2035
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)