NCT03525210

Study of Safety, Tolerability and Immunogenicity of Gardasil®9 in Immunocompromised Patients

An Open-label Phase III Study to Investigate the Safety, Tolerability and Immunogenicity of a Nine-valent Human Papillomavirus (HPV) Vaccine (Gardasil®9) in Solid Organ Transplant Recipients and HIV-infected Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 271 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Patients with immunodeficiencies are at increased risk of developing persistent HPV infection and as such HPV-related disease (genital warts and cancer). In this study HIV-patients and SOT-patients will receive 3 doses of Gardasil®9. Safety, tolerability and immunogenicity will be evaluated up to one month following the 3rd and last dose of Gardasil®9.

Detailed description

This is a single-center, open-label study on safety, tolerability and immunogenicity of Gardasil®9 in 18 to 45 year-old HIV patients, in 18 to 55 year-old solid-organ transplant (SOT) patients. This study will enrol 140 HIV patients with CD4+ (cluster of differentiation 4) count of \>200cells/mm² and 170 SOT patients, all of whom have not yet received a prophylactic HPV vaccine. The 170 SOT patients will be equally divided over 3 different SOT patient groups, namely heart, lung and kidney transplant patients. Therefore the target is to include approximately 57 heart transplant patients, 57 lung transplant patients and 57 kidney transplant patients. Enrolment in a SOT subgroup will be stopped when 57 patients have been included unless recruitment cannot be achieved within one of the other SOT-patient population. All enrolled subjects will receive a 3-dose regimen (Day 1, Month 2, and Month 6) of GARDASIL®9. Serum samples will be collected on Day 1 and Month 7 for anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 antibody determination.. The time point for comparison of immune responses will be Month 7, or approximately 4 weeks after the administration of the third dose. The safety/tolerability profile of the vaccine will be evaluated in all subjects in the study. Safety information will be collected on Day 1 through 1 month following the third vaccination or for a total of approximately 7 months for each subject. The immunogenicity and the safety data will be analyzed per group of patients. More specifically a separate analysis of HIV and SOT patients is planned, since it is expected that the immunosuppressive therapy of SOT patients might have a more profound effect on immunogenicity following vaccination. This study will provide a comparison of immunogenicity of Gardasil ®9 in immunocompromised patients, with historical controls (15, 18). The number of subjects to be enrolled in the study was determined based on the primary immunogenicity objective.

Conditions

• Human Papilloma Virus
• Hiv
• Organ Transplants

Interventions

Type	Name	Description
BIOLOGICAL	9-valent HPV vaccine	Vaccination

Timeline

• Start date: 2018-04-04
• Primary completion: 2019-09-01
• Completion: 2020-07-15
• First posted: 2018-05-15
• Last updated: 2020-12-11
• Results posted: 2020-12-11

Locations

1 site across 1 country: Belgium