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 | Unknown

• 1 other identifier: 2011/02_Medicine
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

CKD; HPV infection; HPV vaccine; antibodies titer

Outcome Measures

Primary Outcomes (2)

• 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

• Seroconversion rate

  The seroconversion rate by vaccination will be calculated.

  Day 1 (baseline) and month 7

Secondary Outcomes (2)

• Titer of neutralizing antibody of each HPV type

  Day 1 (bseline) and month 7

• seroconversion rate

  day 1 (baseline) and month 7

Study Arms (1)

Chronic kidney disease

Chronic kidney disease stage IV and V

Biological: HPV-6/11/16/18 vaccine

Interventions

HPV-6/11/16/18 vaccine BIOLOGICAL

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

Also known as: Gardasil

Chronic kidney disease

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Chronic kidney disease stage IV and V population

You may qualify if:

• 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)
• Subject is judged to be in good physical health on the basis of medical history, physical examination, and laboratory testing.
• Subject is able to understand study procedures and agrees to participate in the study by giving written informed consent.
• 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.
• Subject has had no temperature \> 37.8 C (oral) within 24 hours prior to the first injection.
• Subject has no history of genital/anorectal warts,

You may not qualify if:

• Subject is pregnant.
• Subject has a history of known prior vaccination with an HPV vaccine.
• 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.
• Subject is allergic to any vaccine component, including aluminum, yeast, or BENZONASE.
• 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.
• 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.
• Subject is immunocompromised or has been diagnosed as having HIV infection.
• Subject has a known thrombocytopenia or other coagulation disorder that would contraindicate intramuscular injections.
• Subject has a history of recent (within 1 year from the date of enrollment) or ongoing alcohol abuse or other drug abuse.
• Subject is unable to give informed consent.
• Subject has any prior history of genital/anorectal warts

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Papillomavirus Infections

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Study Officials

• Kearkiat Praditpornsilpa, MD

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associted Professor

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: February 18, 2011
• Study Start: February 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 29, 2014

Record last verified: 2014-01

Locations

TH (1)