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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

NCT01298869 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2014-01-29

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Kidney Disease, Stage IV (Severe)
  • Chronic Kidney Disease, Stage V

Interventions

BIOLOGICAL

HPV-6/11/16/18 vaccine

HPV-6/11/16/18 vaccination 3 doses at day 1, month 2, and month 6

Sponsors & Collaborators

  • Chulalongkorn University

    lead OTHER

Principal Investigators

  • Kearkiat Praditpornsilpa, MD · Chulalongkorn University

Eligibility

Min Age
18 Years
Max Age
26 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2014-08-31
Completion
2014-12-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01298869 on ClinicalTrials.gov