Clinical trial NCT05557370: Immunogenicity of HPV Vaccine in Transplant Recipients.
Official title: Prospective Analysis of Immunogenicity of the Nonavalent Human Papillomavirus Vaccination (GARDASIL 9) in Patients Post Solid Organ Transplant
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Chronic Kidney Diseases
Kidney Transplant
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2022-09-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Primary Outcome
timeFrame: 7 months, 12 months and 24 months
Secondary outcomes:
measure: Secondary Outcome
timeFrame: 7 months, 12 months and 24 months
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Lutheran Memorial Hospital
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin/ Froedtert Hospital
name: Denise Uyar, MD
role: PRINCIPAL_INVESTIGATOR
References: