Chronic Kidney DiseasesPhase 4NCT05557370
Immunogenicity of HPV Vaccine in Transplant Recipients.
A Phase 4 study testing Human Papilloma Virus vaccine (GARDASIL 9) in people with Chronic Kidney Diseases and Kidney Transplant, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
To measure levels of HPV antibodies in post-solid-organ transplant recipients who have gotten the HPV9 vaccine. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Chronic Kidney Diseases, Kidney Transplant
- What is being tested?
- Human Papilloma Virus vaccine (GARDASIL 9)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 31 Dec 2035
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedtert Lutheran Memorial Hospital
Milwaukee, Wisconsin, 53226
About this study
Official title: 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.
Read the 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
- Being tested
- Human Papilloma Virus vaccine (GARDASIL 9)
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Human Papilloma Virus vaccine (GARDASIL 9) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 months, 12 months and 24 months
Secondary outcomes (1)
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.
Measured: 7 months, 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start1 Jun 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Denise Uyar, Medical College of Wisconsin
- Investigators
- Denise Uyar, MD, Principal investigator, Medical College of Wisconsin/ Froedtert Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557370
- Sponsor's protocol ID
- HPV MK-MISP 61451
- Status last verified
- Apr 2026
- First submitted
- 14 Sep 2022
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Immunogenicity of the Nonavalent Human Papillomavirus Vaccination (GARDASIL 9) in Patients Post Solid Organ Transplant
- ClinicalTrials.gov ID
- NCT05557370
- Acronym / sponsor ID
- HPV MK-MISP 61451
- Conditions
- Chronic Kidney Diseases, Kidney Transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Biological: Human Papilloma Virus vaccine (GARDASIL 9)Patient between the age of 18 and 45 years with at least 6 months post-solid-organ transplant who has not received GARDASIL 9. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Biological | Interventional |
Primary outcome
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.
1 secondary outcome
Secondary Outcome
Time frame: 7 months, 12 months and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise Uyar, MD principal investigator
Medical College of Wisconsin/ Froedtert Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Human Papilloma Virus vaccine (GARDASIL 9) in people with Chronic Kidney Diseases and Kidney Transplant, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: 7 months, 12 months and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.