title: Immunogenicity of quadrivalent HPV and combined hepatitis A and B vaccine when co-administered or administered one month apart to 9-10 year-old girls according to 0-6 month schedule.
abstract: BACKGROUND
  No immunogenicity data has been reported after a single dose of the quadrivalent HPV vaccine (qHPV-Gardasil®) and no data are available on co-administration of this vaccine with the HAV/HBV vaccine (Twinrix-Junior®). Two pre-licensure studies reported similar anti-HPV but lower anti-HBs titers when co-administering HPV and HBV vaccines.
  
  
  OBJECTIVE
  To assess the immunogenicity of the qHPV and HAV/HBV vaccine when co-administered (Group-Co-adm) or given one month apart (Group-Sep) and to measure the persistence of HPV antibodies three years post-second dose of qHPV vaccine in both study groups.
  
  
  METHODS
  416 9-10 year-old girls were enrolled. Vaccination schedule was 0-6 months. Anti-HAV and anti-HBs were measured in all subjects 6 months post-first dose and 1 month post-second dose. Anti-HPV were measured 6 months post-first dose in Group-Co-adm and in all subjects 1 and 36 months post-second dose.
  
  
  RESULTS
  Six months post-first dose: 100% of subjects had detectable anti-HAV and 56% and 73% had detectable anti-HBs in Group-Co-Adm and Group-Sep, respectively. In Group-Co-adm 94, 100, 99 and 96% had detectable antibodies to HPV 6, 11, 16 and 18, respectively. One month post-second dose of qHPV and HAV/HBV vaccine, in both study groups 99.5-100% of subjects had an anti-HAV titer ≥ 20IU/L, 97.5-97.6% an anti-HBs level ≥ 10IU/L, and 100% had an anti-HPV titer ≥ 3LU. Thirty-six months post-second dose of qHPV all but four subjects (99%) had antibodies to HPV18 and 100% had antibodies to HPV6, 11 and 16. The great majority (97-100%) had an anti-HPV titer ≥ 3 LU. Post-second dose administration of qHPV and HAV/HBV, no meaningful difference was observed in the immune response in the two study groups to any component of vaccines.
  
  
  CONCLUSIONS
  The results indicate that qHPV and HAV/HBV can be given during the same vaccination session. Two doses of of qHPV and HAV/HBV vaccines induce a strong immune response. Three years post-second dose of qHPV, the great majority of subjects had antibodies to HPV types included in the vaccine. A two-dose schedule for pre-adolescents might be a reasonable alternative to the currently approved three-dose schedules.
authors.affiliation: a Quebec Public Health Institute; Québec, Canada.
authors.forename: Vladimir
authors.initials: V
authors.lastname: Gilca
authors.forename: Chantal
authors.initials: C
authors.lastname: Sauvageau
authors.forename: Nicole
authors.initials: N
authors.lastname: Boulianne
authors.forename: Gaston
authors.initials: G
authors.lastname: De Serres
authors.forename: Michel
authors.initials: M
authors.lastname: Couillard
authors.forename: Mel
authors.initials: M
authors.lastname: Krajden
authors.forename: Manale
authors.initials: M
authors.lastname: Ouakki
authors.forename: Donald
authors.initials: D
authors.lastname: Murphy
authors.forename: Andrea
authors.initials: A
authors.lastname: Trevisan
authors.forename: Marc
authors.initials: M
authors.lastname: Dionne
mesh_terms: D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D005260:Female; D006506:Hepatitis A / Q000517:prevention & control; D022362:Hepatitis A Vaccines / Q000008:administration & dosage / Q000276:immunology*; D006509:Hepatitis B / Q000517:prevention & control; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000276:immunology*; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D006801:Humans; D007115:Immunization Schedule; D030361:Papillomavirus Infections / Q000517:prevention & control; D053918:Papillomavirus Vaccines / Q000008:administration & dosage / Q000276:immunology*; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D022362:Hepatitis A Vaccines; D017325:Hepatitis B Vaccines; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D053918:Papillomavirus Vaccines; D017778:Vaccines, Combined; C433226:twinrix
keywords: HPV; Hepatitis A and B; Immunogenicity; Two doses; Vaccination