The Study of Immunogenicity of Quadrivalent Vaccine Against Human Papilloma Virus (HPV) Types 6, 11, 16, and 18 (HPV-6/11/16/18) in Chronic Kidney Disease (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.
Chronic Kidney Disease, Stage IV (Severe)
Chronic Kidney Disease, Stage V
Biological: HPV-6/11/16/18 vaccine
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|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|
- Titers of neutralizing antibodies for each HPV type [ Time Frame: Day 1 (baseline) and month 7 ] [ Designated as safety issue: No ]The geometric mean titers of neutralizing antibodies for each HPV type at day 1and month 7
- Seroconversion rate [ Time Frame: Day 1 (baseline) and month 7 ] [ Designated as safety issue: No ]The seroconversion rate by vaccination will be calculated.
- Titer of neutralizing antibody of each HPV type [ Time Frame: Day 1 (bseline) and month 7 ] [ Designated as safety issue: No ]The neutralizing antibodies titer between CKD stage IV-V and non-CKD subjects in case-match historical cohort will be analyzed.
- seroconversion rate [ Time Frame: day 1 (baseline) and month 7 ] [ Designated as safety issue: No ]The conversion rate by vaccination between CKD stage IV-V and non-CKD subjects in case-match historical cohort will be analyzed.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Chronic kidney disease
Chronic kidney disease stage IV and V
Biological: HPV-6/11/16/18 vaccine
HPV-6/11/16/18 vaccination 3 doses at day 1, month 2, and month 6
Other Name: Gardasil
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298869
|Chulalongkorn Memorial Hospital||Recruiting|
|Bangkok, Thailand, 10330|
|Contact: Kearkiat Praditpornsilpa, MD 662-2564251 ext 203 email@example.com|
|Principal Investigator: Kearkiat Praditpornsilpa, MD|
|Principal Investigator:||Kearkiat Praditpornsilpa, MD||Chulalongkorn University|