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Travel Med Infect Dis. 2015 May-Jun;13(3):241-50. doi: 10.1016/j.tmaid.2015.05.008. Epub 2015 May 18.

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

Author information

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.

KEYWORDS:

Japanese encephalitis; Rabies; Vaccination

PMID:
26005163
DOI:
10.1016/j.tmaid.2015.05.008
[Indexed for MEDLINE]

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