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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Chulalongkorn University
Sponsor:
Information provided by (Responsible Party):
Kearkiat Praditpornsilpa, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01298869
First received: February 1, 2011
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Chronic Kidney Disease, Stage IV (Severe)
Chronic Kidney Disease, Stage V
Biological: HPV-6/11/16/18 vaccine

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 60
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)
Groups/Cohorts Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 26 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Chronic kidney disease stage IV and V population

Criteria

Inclusion Criteria:

  1. Subject is between the ages 18 - 26 years as of visit 1 and has GFR < 30 mL/min/1.73 m2 by Modification of Diet in Renal Disease (MDRD) equation: eGFR = 175 x serum creatinine(-1.154) x Age(-0.203) x 0.742 (if female)
  2. Subject is judged to be in good physical health on the basis of medical history, physical examination, and laboratory testing.
  3. Subject is able to understand study procedures and agrees to participate in the study by giving written informed consent.
  4. Subject is not pregnant now (as determined by a serum pregnancy test or urine pregnancy test sensitive to 25 IU -hCG) and agrees to use effective contraception through Month 7 of the study. Effective contraception will be considered: oral contraceptives, injection or implant contraception.
  5. Subject has had no temperature > 37.8 C (oral) within 24 hours prior to the first injection.
  6. Subject has no history of genital/anorectal warts,

Exclusion Criteria:

  1. Subject is pregnant.
  2. Subject has a history of known prior vaccination with an HPV vaccine.
  3. Subject has a history of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension or shock) that required medical intervention.
  4. Subject is allergic to any vaccine component, including aluminum, yeast, or BENZONASE.
  5. Subject has received any immune globulin or blood derived products within the 3 months prior to the first injection, or plans to receive any through Month 7 of the study.
  6. Subject has a history of splenectomy, known immune disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis), or receiving immunosuppressives (e.g., substances or treatments known to diminish the immune response such as radiation therapy, administration of antimetabolites, antilymphocytic sera, systemic corticosteroids). Individuals who have received periodic treatments with immunosuppressives, defined as at least 3 courses of oral corticosteroids each lasting at least 1 week in duration for the year prior to enrollment, will be excluded. Subjects using topical steroids (i.e., inhaled, nasal, or topical) will be eligible for vaccination.
  7. Subject is immunocompromised or has been diagnosed as having HIV infection.
  8. Subject has a known thrombocytopenia or other coagulation disorder that would contraindicate intramuscular injections.
  9. Subject has a history of recent (within 1 year from the date of enrollment) or ongoing alcohol abuse or other drug abuse.
  10. Subject is unable to give informed consent.
  11. Subject has any prior history of genital/anorectal warts
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298869

Locations
Thailand
Chulalongkorn Memorial Hospital Recruiting
Bangkok, Thailand, 10330
Contact: Kearkiat Praditpornsilpa, MD    662-2564251 ext 203    kearkiat@hotmail.com   
Principal Investigator: Kearkiat Praditpornsilpa, MD         
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Kearkiat Praditpornsilpa, MD Chulalongkorn University
  More Information

No publications provided

Responsible Party: Kearkiat Praditpornsilpa, Associted Professor, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01298869     History of Changes
Other Study ID Numbers: 2011/02_Medicine
Study First Received: February 1, 2011
Last Updated: January 27, 2014
Health Authority: Thailand: Institutional Review Board, Faculty of Medicine, Chulalongkorn University

Keywords provided by Chulalongkorn University:
CKD
HPV infection
HPV vaccine
antibodies titer

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on September 30, 2014