title: Co-administration of a meningococcal glycoconjugate ACWY vaccine with travel vaccines: a randomized, open-label, multi-center study.
abstract: BACKGROUND
  Potential interactions between vaccines may compromise the immunogenicity and/or safety of individual vaccines so must be assessed before concomitant administration is recommended. In this study, the immunogenicity and safety of travel vaccines against Japanese encephalitis (JEV) and rabies (PCECV) administered together with or without a quadrivalent meningococcal glycoconjugate ACWY-CRM vaccine were evaluated (NCT01466387).
  
  
  METHODS
  Healthy adults aged 18 to ≤60 years were randomized to one of four vaccine regimens: JEV + PCECV + MenACWY-CRM, JEV + PCECV, PCECV or MenACWY-CRM. Immunogenicity at baseline and 28 days post-complete vaccination was assessed by serum bactericidal assay using human complement or neutralization tests. Adverse events (AEs) were collected throughout the study period.
  
  
  RESULTS
  JEV + PCECV + MenACWY-CRM was non-inferior to JEV + PCECV. Post-vaccination seroprotective neutralizing titers or concentrations were achieved in 98-99% (JE) and 100% (rabies) of subjects across the vaccine groups. Antibody responses to vaccine meningococcal serogroups were in the same range for MenACWY-CRM and JEV + PCECV + MenACWY-CRM. Rates of reporting of AEs were similar for JEV + PCECV and JEV + PCECV + MenACWY-CRM.
  
  
  CONCLUSIONS
  MenACWY-CRM was administered with an inactivated adjuvanted JE and a purified chick embryo cell-culture rabies vaccine without compromising immunogenicity or safety of the individual vaccines. These data provide evidence that MenACWY-CRM could be effectively incorporated into travel vaccination programs.
  
  
  BACKGROUND
  NCT01466387.
authors.affiliation: Department of Infectious Diseases and Tropical Medicine, University of Munich, Munich, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Alberer
authors.affiliation: University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Gerd
authors.initials: G
authors.lastname: Burchard
authors.affiliation: Berlin Center for Travel and Tropical Medicine, Berlin, Germany.
authors.forename: Tomas
authors.initials: T
authors.lastname: Jelinek
authors.affiliation: Department of Tropical Medicine and Infectious Diseases, University of Rostock Medical School, Rostock, Germany.
authors.forename: Emil
authors.initials: E
authors.lastname: Reisinger
authors.affiliation: Vaccination and Travel Medicine Centre, Hradec Kralove, Czech Republic.
authors.forename: Jiri
authors.initials: J
authors.lastname: Beran
authors.affiliation: Novartis Vaccines and Diagnostics, Inc., Cambridge, MA, USA.
authors.forename: Seetha
authors.initials: S
authors.lastname: Meyer
authors.affiliation: Novartis Vaccines and Diagnostics, Inc., Cambridge, MA, USA.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Forleo-Neto
authors.affiliation: Novartis Vaccines and Diagnostics, Inc., Cambridge, MA, USA.
authors.forename: Dieter
authors.initials: D
authors.lastname: Gniel
authors.affiliation: Novartis Vaccines and Diagnostics, Inc., Cambridge, MA, USA.
authors.forename: Alemnew F
authors.initials: AF
authors.lastname: Dagnew
authors.affiliation: Novartis Vaccines and Diagnostics, Inc., Cambridge, MA, USA. Electronic address: ashwani_kumar.arora@novartis.com.
authors.forename: Ashwani Kumar
authors.initials: AK
authors.lastname: Arora
mesh_terms: D000328:Adult; D000962:Antimalarials / Q000008:administration & dosage; D003140:Communicable Disease Control / Q000706:statistics & numerical data*; D003141:Communicable Diseases / Q000453:epidemiology; D003430:Cross-Sectional Studies; D005260:Female; D006801:Humans; D008297:Male; D008589:Meningococcal Infections / Q000517:prevention & control; D022401:Meningococcal Vaccines / Q000008:administration & dosage*; D008875:Middle Aged; D014195:Travel / Q000706:statistics & numerical data*; D057236:Travel Medicine; D014611:Vaccination / Q000706:statistics & numerical data*; D014612:Vaccines / Q000008:administration & dosage*; D018074:Vaccines, Conjugate / Q000008:administration & dosage; D055815:Young Adult
chemical_list: D000962:Antimalarials; C525703:MenACWY; D022401:Meningococcal Vaccines; D014612:Vaccines; D018074:Vaccines, Conjugate
keywords: Co-administration; Japanese encephalitis; Meningococcal disease; Rabies; Vaccine