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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 CKD Patients

18 Years
26 Years
Open (Enrolling)
Chronic Kidney Disease, Stage IV (Severe), Chronic Kidney Disease, Stage V

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Trial Information

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.

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

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

4. Subject is allergic to any vaccine component, including aluminum, yeast, or

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

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

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Titers of neutralizing antibodies for each HPV type

Outcome Description:

The geometric mean titers of neutralizing antibodies for each HPV type at day 1and month 7

Outcome Time Frame:

Day 1 (baseline) and month 7

Safety Issue:


Principal Investigator

Kearkiat Praditpornsilpa, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chulalongkorn University


Thailand: Institutional Review Board, Faculty of Medicine, Chulalongkorn University

Study ID:




Start Date:

February 2011

Completion Date:

February 2012

Related Keywords:

  • Chronic Kidney Disease, Stage IV (Severe)
  • Chronic Kidney Disease, Stage V
  • CKD
  • HPV infection
  • HPV vaccine
  • antibodies titer
  • Kidney Diseases
  • Papilloma
  • Renal Insufficiency, Chronic
  • Kidney Failure, Chronic