title: Evaluation of rabies immunogenicity and tolerability following a purified chick embryo cell rabies vaccine administered concomitantly with a Japanese encephalitis vaccine.
abstract: BACKGROUND
  For individuals traveling at short notice to rabies and Japanese encephalitis (JE) endemic countries, concomitant administration of travel vaccines within a short period is often required.
  
  
  METHODS
  The aim of this study was to determine whether an accelerated (one-week: Days 1-8) pre-exposure rabies (Rabipur(®), Novartis Vaccines) vaccination regimen administered concomitantly with a Japanese encephalitis (JE) vaccination (Ixiaro(®), Valneva) regimen, is non-inferior to the standard (four-week: Days 1, 8, 29) rabies regimen administered alone or concomitantly with the JE vaccine. Healthy adults (18 to ≤ 65 years) were randomized into Rabies + JE-Standard, Rabies + JE-Accelerated, Rabies-Standard and JE-Standard groups. Relative immunogenicity for rabies in each regimen was assessed using the rapid fluorescent focus inhibition test. Safety was evaluated up to and including Day 57.
  
  
  RESULTS
  Non-inferior immunogenicity for rabies was established between the Rabies + JE-Accelerated group compared to both the Rabies-Standard and Rabies + JE-Standard groups; as well as between the Rabies + JE-Standard regimen and the Rabies-Standard regimen. By Day 57, adequate neutralizing levels were achieved by 97-100% of subjects across all groups. Adverse events (AEs) were comparable for all groups.
  
  
  CONCLUSIONS
  An accelerated pre-exposure rabies and JE vaccination regimen is non-inferior to the standard four-week rabies regimen and may thus provide a more convenient regimen for individuals traveling to endemic countries at short notice. NCT01662440.
authors.affiliation: Berlin Center for Travel and Tropical Medicine, Berlin, Germany.
authors.forename: Tomas
authors.initials: T
authors.lastname: Jelinek
authors.affiliation: Bernhard Nocht Institute for Tropical Medicine, Department of Clinical Research/University Medical Center Hamburg-Eppendorf, Department of Internal Medicine, Section Tropical Medicine, Hamburg, Germany.
authors.forename: Jakob P
authors.initials: JP
authors.lastname: Cramer
authors.affiliation: Institute of Tropical Medicine and International Health, Charité-Universitaetsmedizin Berlin, Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Dieckmann
authors.affiliation: Institute of Social and Preventive Medicine, University of Zürich, Switzerland.
authors.forename: Christoph
authors.initials: C
authors.lastname: Hatz
authors.affiliation: Institute of Specific Prophylaxis and Tropical Medicine, Medical University Vienna, Austria.
authors.forename: Maria
authors.initials: M
authors.lastname: Paulke-Korinek
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: Department of Tropical Medicine and Infectious Diseases, University of Rostock Medical School, Rostock, Germany.
authors.forename: Emil C
authors.initials: EC
authors.lastname: Reisinger
authors.affiliation: Novartis Vaccines and Diagnostics Srl - a GSK company, Siena, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Costantini
authors.affiliation: Novartis Vaccines and Diagnostics Srl - a GSK company, Marburg, Germany.
authors.forename: Dieter
authors.initials: D
authors.lastname: Gniel
authors.affiliation: Novartis Vaccines and Diagnostics Srl - a GSK company, Marburg, Germany.
authors.forename: Dietrich
authors.initials: D
authors.lastname: Bosse
authors.affiliation: Novartis Vaccines and Diagnostics Srl - a GSK company, Siena, Italy. Electronic address: maria.x.lattanzi@gsk.com.
authors.forename: Maria
authors.initials: M
authors.lastname: Lattanzi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000818:Animals; D057134:Antibodies, Neutralizing / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D002642:Chick Embryo; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D022321:Japanese Encephalitis Vaccines / Q000008:administration & dosage* / Q000276:immunology; D008297:Male; D008875:Middle Aged; D011818:Rabies / Q000517:prevention & control*; D011819:Rabies Vaccines / Q000008:administration & dosage* / Q000276:immunology*; D011820:Rabies virus / Q000276:immunology*; D014195:Travel; D014611:Vaccination / Q000379:methods; D055815:Young Adult
chemical_list: D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D022321:Japanese Encephalitis Vaccines; D011819:Rabies Vaccines
keywords: Japanese encephalitis; Rabies; Vaccination