title: The safety and immunogenicity of Quadrivalent HPV (qHPV) vaccine in systemic lupus erythematosus.
abstract: This study evaluated the safety and immunogenicity of qHPV vaccine in SLE.
  
  
  
  Subjects: 34 women ages 19-50years (yrs.) with mild to moderate SLE & minimally active or inactive SLE received qHPV vaccine at the standard dosing schedule.
  
  
  
  active SLE disease (SELENA-SLEDAI>2), history of severe SLE disease, deep venous thrombosis, on >400mg/day of hydroxychloroquine, on >15mg/day of prednisone, or active infections. Patients were monitored for adverse events (AE), SLE flare, generation of thrombogenic antibodies and thrombosis. Antibody (Ab) levels to HPV 6, 11, 16 & 18 were measured by HPV competitive Luminex Immunoassay and Geometric Mean Titers (GMTs) were calculated for each HPV type. Seroconversion was assessed for those seronegative at baseline.
  
  
  
  The women in the study: African-American (79%), mean age=38.1years, mean age at diagnosis of SLE=28.6years, 35.3% had a history of smoking, 91% had 4 or more sexual partners, 50% had a history of sexually transmitted diseases, and 27.3% used condoms on a regular basis. Vaccine site reactions (VSRs) occurred in 62%, all mild. Ninety-seven percent experienced at least 1 non vaccine adverse event (nvAE) with a total of 493 nvAEs in 33 patients, of which 90% were mild and none were related to vaccine or SLE. There were 9 serious AEs, none were related to vaccine or SLE, all resolved. No patient experienced an SLE flare, thrombosis, or generation of thrombogenic antibodies. Seroconversion rate was 100% with mean GMTs comparable to Gardasil® package insert data.
  
  
  
  In this SLE vaccine study, qHPV vaccine was generally safe, well tolerated, and highly immunogenic. This clinical trial is registered on Clinical Trials.gov under number, NCT01741012 and was conducted under the FDA IND BB14113.
authors.affiliation: Wayne State University School of Medicine, Detroit, MI, United States; Central Michigan University College of Medicine, Mt. Pleasant/Saginaw, MI, United States. Electronic address: pdhar@med.wayne.edu.
authors.forename: J Patricia
authors.initials: JP
authors.lastname: Dhar
authors.affiliation: Wayne State University School of Medicine, Detroit, MI, United States.
authors.forename: Lynnette
authors.initials: L
authors.lastname: Essenmacher
authors.affiliation: Central Michigan University College of Medicine, Mt. Pleasant, MI, United States.
authors.forename: Renee
authors.initials: R
authors.lastname: Dhar
authors.affiliation: Wayne State University School of Medicine, Detroit, MI, United States.
authors.forename: Ardella
authors.initials: A
authors.lastname: Magee
authors.affiliation: Wayne State University School of Medicine, Detroit, MI, United States.
authors.forename: Joel
authors.initials: J
authors.lastname: Ager
authors.affiliation: Wayne State University School of Medicine, Detroit, MI, United States.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Sokol
mesh_terms: D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000150:complications*; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000517:prevention & control*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
keywords: Cervical cancer; Cervical neoplasia; Human papillomavirus; Systemic lupus erythematosus; Vaccine immunogenicity; Vaccine safety