HPV vaccine effectiveness in kidney transplant recipients
Prospective Analysis of Immunogenicity of the Nonavalent Human Papillomavirus Vaccination (GARDASIL 9) in Patients Post Solid Organ Transplant
This study is testing how well the GARDASIL 9 HPV vaccine works in adults aged 18-45 who have had a kidney transplant to see if it helps boost their immune response.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT05557370 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the immune response to the GARDASIL 9 HPV vaccine in adults aged 18-45 who have received a solid organ transplant. It is a prospective, open-label, nonrandomized cohort study conducted at a single center over a period of 36 months, with participants receiving a 3-dose vaccination series. Blood samples will be collected at various intervals to measure HPV antibody levels and assess the immunogenicity of the vaccine in this immunocompromised population. The study will also explore the potential for future research through optional blood banking.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-45 who are at least 6 months post-solid organ transplant and have not previously received the GARDASIL 9 vaccine.
Not a fit: Patients with a history of severe allergic reactions to vaccine components, those who have already completed the GARDASIL 9 vaccination series, or individuals diagnosed with HIV may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of HPV vaccine efficacy in immunocompromised patients, potentially leading to improved vaccination strategies.
How similar studies have performed: While there have been studies on HPV vaccination in general populations, this specific approach in immunocompromised transplant recipients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Milwaukee, Wisconsin
- Froedtert Lutheran Memorial Hospital — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Denise Uyar, MD — Medical College of Wisconsin/ Froedtert Hospital
- Study coordinator: Subarna Paul
- Email: supaul@mcw.edu
- Phone: (414) 805-8594
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.