Evaluation of rabies immunogenicity and tolerability following a purified chick embryo cell rabies vaccine administered concomitantly with a Japanese encephalitis vaccine

• Published in: Travel medicine and infectious disease Vol. 13; no. 3; pp. 241 - 250
• Main Authors: Jelinek, Tomas, Cramer, Jakob P., Dieckmann, Sebastian, Hatz, Christoph, Paulke-Korinek, Maria, Alberer, Martin, Reisinger, Emil C., Costantini, Marco, Gniel, Dieter, Bosse, Dietrich, Lattanzi, Maria
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 01.05.2015; Elsevier Limited
• Subjects: Adolescent; Adult; Aged; Animals; Antibodies, Neutralizing - blood; Antibodies, Viral - blood; Chick Embryo; Confidence intervals; Expatriates; Female; Humans; Immunization; Immunization Schedule; Immunogenicity; Infectious Disease; Japanese encephalitis; Japanese Encephalitis Vaccines - administration & dosage; Japanese Encephalitis Vaccines - immunology; Male; Middle Aged; Rabies; Rabies - prevention & control; Rabies Vaccines - administration & dosage; Rabies Vaccines - immunology; Rabies virus - immunology; Travel; Travel medicine; Tropical diseases; Vaccination; Vaccination - methods; Vaccines; Vector-borne diseases; Young Adult; Asia; RVNA; JE; GMC; Rabies; Vaccination; Japanese encephalitis; geometric mean concentrations; rabies virus neutralizing antibody
• ISSN: 1477-8939; 1873-0442; 1873-0442
• DOI: 10.1016/j.tmaid.2015.05.008

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. 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. 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. 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.