title: Immunogenicity and safety of the bivalent HPV vaccine in female patients with juvenile idiopathic arthritis: a prospective controlled observational cohort study.
abstract: OBJECTIVE
  To compare the immunogenicity and safety of the bivalent human papillomavirus (HPV)16/18 vaccine between female patients with juvenile idiopathic arthritis (JIA) and healthy female adolescents.
  
  
  METHODS
  68 patients and 55 healthy girls aged 12-18 years were included in a prospective controlled observational cohort and were vaccinated at 0, 1 and 6 months. Primary outcomes were immunogenicity expressed as seropositivity rate after three vaccine doses at 7 and 12 months and HPV-specific geometric mean antibody concentrations. Secondary outcomes were HPV16/18-specific memory B cell responses in a subset of participants and safety, defined as adverse events and the effect of vaccination on JIA disease activity.
  
  
  RESULTS
  All participants were seropositive for HPV16 and HPV18 at 7 months. One patient turned seronegative at 12 months for HPV16/18. No significant differences were found between patients and controls in HPV-specific antibody concentrations; however, antibody concentrations were consistently lower in patients. No effect of methotrexate on HPV16 antibodies (p=0.79) or HPV18 antibodies (p=0.37) was detected. All patients on anti-TNFα treatment were seropositive after vaccination. The kinetics of HPV16/18 memory B cell responses was comparable between patients and controls, but the magnitude of B cell responses at 7 and 12 months appeared lower in patients. No relevant differences in adverse events were found. HPV vaccination did not aggravate JIA disease.
  
  
  CONCLUSIONS
  The bivalent HPV16/18 vaccine is immunogenic and well tolerated in JIA patients. However, HPV-specific antibodies and B cell responses tended to be lower in patients compared with healthy controls.
  NCT00815282.
authors.affiliation: Department of Paediatric Immunology, Wilhelmina Children's Hospital, University Medical Centre Utrecht, Utrecht, The Netherlands.
authors.forename: Marloes W
authors.initials: MW
authors.lastname: Heijstek
authors.affiliation: Laboratory for Infectious Diseases and Screening, Centre for Infectious Disease Control Netherlands, National Institute of Public Health and the Environment (RIVM), Bilthoven, The Netherlands Department of Pathology, VU University Medical Centre, Amsterdam, The Netherlands.
authors.forename: Mirte
authors.initials: M
authors.lastname: Scherpenisse
authors.affiliation: Department of Paediatric Immunology, Wilhelmina Children's Hospital, University Medical Centre Utrecht, Utrecht, The Netherlands.
authors.forename: Noortje
authors.initials: N
authors.lastname: Groot
authors.affiliation: Department of Paediatric Immunology, Wilhelmina Children's Hospital, University Medical Centre Utrecht, Utrecht, The Netherlands.
authors.forename: Carline
authors.initials: C
authors.lastname: Tacke
authors.affiliation: Laboratory for Infectious Diseases and Screening, Centre for Infectious Disease Control Netherlands, National Institute of Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
authors.forename: Rutger M
authors.initials: RM
authors.lastname: Schepp
authors.affiliation: Laboratory for Infectious Diseases and Screening, Centre for Infectious Disease Control Netherlands, National Institute of Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Buisman
authors.affiliation: Laboratory for Infectious Diseases and Screening, Centre for Infectious Disease Control Netherlands, National Institute of Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
authors.forename: Guy A M
authors.initials: GA
authors.lastname: Berbers
authors.affiliation: Laboratory for Infectious Diseases and Screening, Centre for Infectious Disease Control Netherlands, National Institute of Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
authors.forename: Fiona R M
authors.initials: FR
authors.lastname: van der Klis
authors.affiliation: Department of Paediatric Immunology, Wilhelmina Children's Hospital, University Medical Centre Utrecht, Utrecht, The Netherlands.
authors.forename: Nico M
authors.initials: NM
authors.lastname: Wulffraat
mesh_terms: D000293:Adolescent; D002648:Child; D005260:Female; D006801:Humans; D000914:Antibodies, Viral / Q000097:blood; D001171:Arthritis, Juvenile / Q000276:immunology; D005500:Follow-Up Studies; D052162:Human papillomavirus 16 / Q000276:immunology; D052161:Human papillomavirus 18 / Q000276:immunology; D030361:Papillomavirus Infections / Q000276:immunology / Q000517:prevention & control; D053918:Papillomavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D011446:Prospective Studies; D002583:Uterine Cervical Neoplasms / Q000276:immunology / Q000517:prevention & control
chemical_list: D000914:Antibodies, Viral; D053918:Papillomavirus Vaccines