title: Immunogenicity and safety of quadrivalent human papillomavirus types 6/11/16/18 recombinant vaccine in chronic kidney disease stage IV, V and VD.
abstract: Up to >80% of sexually active adults will become infected with human papillomavirus (HPV) during their lifetime. Persistent HPV infection can result in cervical, vulvovaginal, penile and anogenital cancer. Clinical studies have shown the efficacy of three doses of quadrivalent HPV-6/11/16/18 L1 virus-like particle (VLP) vaccination, at Day 0, Month 2 and Month 6, to lower the occurrence of HPV infection and its complications. However, immunogenicity and safety of the HPV vaccine have not been proven in the chronic kidney disease (CKD) population.
  
  
  
  Sixty CKD stage IV, V and VD patients were enrolled for quadrivalent HPV-6/11/16/18 vaccination. A dose of vaccine was given at Day 0, Month 2 and Month 6. Each dose contained 20 μg HPV-6 L1 VLP, 40 μg HPV-11 L1 VLP, 40 μg HPV-16 L1 VLP and 20 μg HPV-18 L1 VLP, along with 225 μg of amorphous aluminum hydroxyphosphate sulfate adjuvant. HPV type-specific antibody response to neutralizing epitopes on HPV-6/11/16/18 was performed by multiplexed, competitive Luminex® immunoassays (cLIA) at Day 0 and Month 7.
  
  
  
  At Day 0, anti-HPV seropositivity was 0-6.6% depending on HPV genotype. Patients who received three doses of vaccine had 98.2, 100, 100 and 98.2% seropositivity for genotypes 6/11/16/18, respectively. The average cLIA at Month 7 for genotypes 6/11/16/18 were 928.4 ± 231.1, 1136.1 ± 264.6, 6951.0 ± 1872.3 and 2196.3 ± 761.2 milliMerck units (mMu)/mL, respectively. No serious vaccine-related adverse events were observed.
  
  
  
  Quadrivalent HPV vaccine has been well tolerated, is safe and provides excellent immunogenicity in late-stage CKD.
authors.affiliation: Division of Nephrology, Department of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
authors.forename: Kearkiat
authors.initials: K
authors.lastname: Praditpornsilpa
authors.affiliation: Department of Pediatrics, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
authors.forename: Pornchai
authors.initials: P
authors.lastname: Kingwatanakul
authors.affiliation: Department of Pediatrics, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
authors.forename: Tawatchai
authors.initials: T
authors.lastname: Deekajorndej
authors.affiliation: Department of Pediatrics, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
authors.forename: Pornpimol
authors.initials: P
authors.lastname: Rianthavorn
authors.affiliation: Division of Nephrology, Department of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
authors.forename: Paweena
authors.initials: P
authors.lastname: Susantitaphong
authors.affiliation: Division of Nephrology, Department of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
authors.forename: Pisut
authors.initials: P
authors.lastname: Katavetin
authors.affiliation: Division of Nephrology, Department of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
authors.forename: Khajohn
authors.initials: K
authors.lastname: Tiranathanakul
authors.affiliation: Division of Nephrology, Department of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
authors.forename: Nattachai
authors.initials: N
authors.lastname: Srisawat
authors.affiliation: Division of Nephrology, Department of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
authors.forename: Kriang
authors.initials: K
authors.lastname: Tungsanga
authors.affiliation: Division of Nephrology, Department of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
authors.forename: Somchai
authors.initials: S
authors.lastname: Eiam-Ong
authors.affiliation: Division of Nephrology, Department of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
authors.forename: Natavudh
authors.initials: N
authors.lastname: Townamchai
mesh_terms: D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 / Q000008:administration & dosage / Q000276:immunology*; D006801:Humans; D007118:Immunoassay; D008297:Male; D030361:Papillomavirus Infections / Q000453:epidemiology / Q000517:prevention & control* / Q000821:virology; D015995:Prevalence; D011446:Prospective Studies; D051436:Renal Insufficiency, Chronic / Q000453:epidemiology / Q000517:prevention & control* / Q000821:virology; D013785:Thailand / Q000453:epidemiology; D014611:Vaccination; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
keywords: CKD; HPV vaccine; cancer