Chronic Kidney Disease, Stage IV (Severe) Clinical Trial
Official title:
The Study of Immunogenicity of Quadrivalent Vaccine Against Human Papilloma Virus (HPV) Types 6, 11, 16, and 18 (HPV-6/11/16/18) in CKD Patients
Clinical trials have demonstrated the efficacy of HPV-6/11/16/18 vaccination (Gardasil.
Merck) 3 doses at day 1, month 2, and month 6 to lower the occurrence of high-grade cervical
intraepithelial neoplasia than did those in the placebo group. The immunogenicity and
efficacy of the HPV vaccine has not been proven in late stage chronic kidney disease (CKD)
population. The cellular and humoral immune responsiveness of CKD population are impaired by
the retention of uremic toxin due to glomerular filtration rate (GFR) reduction, the
vaccination efficacy can be altered and the effective dose/schedule of the vaccine may need
to be adjusted, mostly increase in CKD patients.
This study aims to investigate the immunogenicity of quadrivalent HPV-6/11/16/18 vaccination
(Gardasil. Merck) by current recommended dose/schedule in CKD stage IV-V patients and compare
to non-CKD patients. Although a minimal peak anti-HPV response associated with protective
efficacy has not been determined, the equivalent immune response in CKD and non-CKD patients
if can be demonstrated by this study should be extrapolated to the CKD population. If less
immune response results, the more intense dose/schedule of the vaccine should be further
studied.
Up to 70% of sexually active adults will become infected with human papillomavirus (HPV) during their lifetime. HPV infection can result in anogenital cancer and genital warts. These diseases are associated with substantial morbidity and mortality. Every year, 471,000 cases of cervical cancer are diagnosed worldwide. The 5-year survival for this disease is ~70%. The incidence of HPV-related anal cancer has doubled in the last 25 years. Screening programs to detect early disease are not available. Genital warts cause significant morbidity. Therefore, a prophylactic vaccine that reduces HPV infection will greatly reduce the burden of HPV disease. This study aims to demonstrate the immunogenicity of quadrivalent HPV-6/11/16/18 vaccination (Gardasil. Merck) by current recommended dose/schedule (day 1, and month 7) in CKD stage IV-V patients and to compare the immunogenicity of the vaccine in CKD stage IV-V patients and non-CKD subjects in historical cohort data. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05630729 -
Living With CKD: An E-Learning Platform for Adolescents With CKD About the Disease and Its Management
|
N/A | |
| Withdrawn |
NCT03857633 -
MRI Assessment of Myocardial Fibrosis Associated With Monocyte Phenotype in End Stage Renal Failure
|
||
| Terminated |
NCT00837824 -
Severe Renal Disease Study in Fabry Patients Treated With Fabrazyme
|
Phase 2 |