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
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.
Observational
Observational Model: Case-Only, Time Perspective: Prospective
Titers of neutralizing antibodies for each HPV type
The geometric mean titers of neutralizing antibodies for each HPV type at day 1and month 7
Day 1 (baseline) and month 7
No
Kearkiat Praditpornsilpa, MD
Principal Investigator
Chulalongkorn University
Thailand: Institutional Review Board, Faculty of Medicine, Chulalongkorn University
2011/02_Medicine
NCT01298869
February 2011
February 2012
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