title: Immunogenicity and safety of a quadrivalent human papillomavirus vaccine in patients with systemic lupus erythematosus: a case-control study.
abstract: OBJECTIVE
  To evaluate the immunogenicity and safety of GARDASIL, a quadrivalent human papillomavirus (HPV) vaccine, in patients with systemic lupus erythematosus (SLE).
  
  
  METHODS
  Women with SLE aged 18-35 years who had stable disease were recruited to receive GARDASIL vaccination and an equal number of age-matched healthy women were also vaccinated. Seroconversion rates of antibodies to HPV serotypes 6, 11, 16 and 18 at months 7 and 12 and adverse events (AEs) were compared between patients and controls. The rate of disease flares in SLE participants was compared with matched SLE controls.
  
  
  RESULTS
  50 patients with SLE and 50 healthy controls were studied. The mean age and disease duration of the patients was 25.8±3.9 years and 6.6±4.5 years, respectively. At month 12 the seroconversion rates of anti-HPV serotypes 6, 11, 16 and 18 in patients and controls were 82%, 89%, 95%, 76% and 98%, 98%, 98%, 80%, respectively. In patients with SLE there were no significant changes in the titres of anti-dsDNA, complements, anti-C1q and SLE Disease Activity Index scores from baseline to months 2, 7 and 12. There was one mild/moderate SLE flare at months 0-2, two mild/moderate flares at months 3-6 and six mild/moderate and two severe flares at months 7-12. Disease flares in patients with SLE occurred at a similar frequency to that of 50 matched SLE controls (0.22/patient/year vs 0.20/patient/year, p=0.81). Injection site reaction was the commonest AE (5%), and the incidence of AEs was comparable between patients with SLE and controls.
  
  
  CONCLUSIONS
  The quadrivalent HPV vaccine is well tolerated and reasonably effective in patients with stable SLE and does not induce an increase in lupus activity or flares.
authors.affiliation: Department of Medicine, Tuen Mun and Pok Oi Hospital, New Territories, Hong Kong, SAR China. ccmok2005@yahoo.com
authors.forename: Chi Chiu
authors.initials: CC
authors.lastname: Mok
authors.forename: Ling Yin
authors.initials: LY
authors.lastname: Ho
authors.forename: Lai Shan
authors.initials: LS
authors.lastname: Fong
authors.forename: Chi Hung
authors.initials: CH
authors.lastname: To
mesh_terms: D000293:Adolescent; D000328:Adult; D052685:Alphapapillomavirus / Q000276:immunology*; D000914:Antibodies, Viral / Q000097:blood; D016022:Case-Control Studies; D018450:Disease Progression; D005260:Female; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D006801:Humans; D016867:Immunocompromised Host / Q000276:immunology*; D008180:Lupus Erythematosus, Systemic / Q000276:immunology*; D030361:Papillomavirus Infections / Q000276:immunology / Q000517:prevention & control*; D053918:Papillomavirus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D053918:Papillomavirus Vaccines