Immunogenicity of HPV Vaccine in Transplant Recipients.

April 29, 2026 updated by: Denise Uyar, Medical College of Wisconsin

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Subarna Paul
  • Phone Number: (414) 805-8594
  • Email: supaul@mcw.edu

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Outcome
Time Frame: 7 months, 12 months and 24 months

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary Outcome
Time Frame: 7 months, 12 months and 24 months

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical College of Wisconsin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Denise Uyar, MD, Medical College of Wisconsin/ Froedtert Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2035

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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