Tomas Jelinek1, Jakob P Cramer2, Sebastian Dieckmann3, Christoph Hatz4, Maria Paulke-Korinek5, Martin Alberer6, Emil C Reisinger7, Marco Costantini8, Dieter Gniel9, Dietrich Bosse9, Maria Lattanzi10. 1. Berlin Center for Travel and Tropical Medicine, Berlin, Germany. 2. Bernhard Nocht Institute for Tropical Medicine, Department of Clinical Research/University Medical Center Hamburg-Eppendorf, Department of Internal Medicine, Section Tropical Medicine, Hamburg, Germany. 3. Institute of Tropical Medicine and International Health, Charité-Universitaetsmedizin Berlin, Germany. 4. Institute of Social and Preventive Medicine, University of Zürich, Switzerland. 5. Institute of Specific Prophylaxis and Tropical Medicine, Medical University Vienna, Austria. 6. Department of Infectious Diseases and Tropical Medicine, University of Munich, Munich, Germany. 7. Department of Tropical Medicine and Infectious Diseases, University of Rostock Medical School, Rostock, Germany. 8. Novartis Vaccines and Diagnostics Srl - a GSK company, Siena, Italy. 9. Novartis Vaccines and Diagnostics Srl - a GSK company, Marburg, Germany. 10. Novartis Vaccines and Diagnostics Srl - a GSK company, Siena, Italy. Electronic address: maria.x.lattanzi@gsk.com.
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.
RCT Entities:
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: Jocelyn A Kessels; Sergio Recuenco; Ana Maria Navarro-Vela; Raffy Deray; Marco Vigilato; Hildegund Ertl; David Durrheim; Helen Rees; Louis H Nel; Bernadette Abela-Ridder; Deborah Briggs Journal: Bull World Health Organ Date: 2016-11-25 Impact factor: 9.408