Human Immunodeficiency Virus Clinical Trial
Official title:
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
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 100 HIV patients with CD4+ 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. The number of subjects to be enrolled in the study was
determined based on the primary immunogenicity objective.
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