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Safety and immunogenicity of a Vero-cell-derived, inactivated Japanese encephalitis vaccine: a non-inferiority, phase III, randomised controlled trial

Summary Background Japanese encephalitis virus (JEV) is the leading cause of viral encephalitis in southeast Asia. Although no treatment is currently available, vaccination effectively prevents the disease. In a non-inferiority study, we aimed to compare the safety and immunogenicity of a novel, sec...

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Published in:The Lancet (British edition) 2007-12, Vol.370 (9602), p.1847-1853
Main Authors: Tauber, E, MD, Kollaritsch, H, MD, Korinek, M, MD, Rendi-Wagner, P, MD, Jilma, B, Dr, Firbas, C, MD, Schranz, S, MD, Jong, E, MD, Klingler, A, PhD, Dewasthaly, S, MD, Klade, CS, PhD
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cited_by cdi_FETCH-LOGICAL-c476t-4b2c430922524f124bd745c527ec0a7c4d42e9c909fda21bbf221b95ebdd13743
cites cdi_FETCH-LOGICAL-c476t-4b2c430922524f124bd745c527ec0a7c4d42e9c909fda21bbf221b95ebdd13743
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container_issue 9602
container_start_page 1847
container_title The Lancet (British edition)
container_volume 370
creator Tauber, E, MD
Kollaritsch, H, MD
Korinek, M, MD
Rendi-Wagner, P, MD
Jilma, B, Dr
Firbas, C, MD
Schranz, S, MD
Jong, E, MD
Klingler, A, PhD
Dewasthaly, S, MD
Klade, CS, PhD
description Summary Background Japanese encephalitis virus (JEV) is the leading cause of viral encephalitis in southeast Asia. Although no treatment is currently available, vaccination effectively prevents the disease. In a non-inferiority study, we aimed to compare the safety and immunogenicity of a novel, second-generation, inactivated candidate vaccine for JEV with a licensed, mouse-brain-derived vaccine. Methods We included 867 adults in a multicentre, multinational, observer-blinded, randomised controlled phase III trial. Study sites were located in the USA, Germany, and Austria. Volunteers received either the JEV test vaccine intramuscularly on a two-dose schedule (on days 0 and 28; n=430) or the licensed vaccine subcutaneously according to its recommended three-dose schedule (on days 0, 7, and 28; n=437). The primary endpoint was immunogenicity, with respect to neutralising JEV-specific antibodies assessed by a plaque-reduction neutralisation test, which was assessable in 725 patients in the per-protocol population. This trial is registered as a clinical trial, EudraCT number 2004-002474-36. Findings The safety profile of the test vaccine was good, and its local tolerability profile was more favourable than that of the licensed vaccine. Frequency of adverse events was similar between treatment groups, and vaccine-related adverse events were generally mild. The seroconversion rate of the test vaccine was 98% compared with 95% for the licensed vaccine on day 56 (95% CI for the difference −1·33 to 3·43). Geometric mean titre for recipients of the test vaccine was 244 (range 5–19 783), compared with 102 (5–1864) for the licensed vaccine (ratio 2·3 [95% CI 1·967–2·75]). Interpretation The test JEV vaccine has a promising immunogenicity and safety profile.
doi_str_mv 10.1016/S0140-6736(07)61780-2
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Although no treatment is currently available, vaccination effectively prevents the disease. In a non-inferiority study, we aimed to compare the safety and immunogenicity of a novel, second-generation, inactivated candidate vaccine for JEV with a licensed, mouse-brain-derived vaccine. Methods We included 867 adults in a multicentre, multinational, observer-blinded, randomised controlled phase III trial. Study sites were located in the USA, Germany, and Austria. Volunteers received either the JEV test vaccine intramuscularly on a two-dose schedule (on days 0 and 28; n=430) or the licensed vaccine subcutaneously according to its recommended three-dose schedule (on days 0, 7, and 28; n=437). The primary endpoint was immunogenicity, with respect to neutralising JEV-specific antibodies assessed by a plaque-reduction neutralisation test, which was assessable in 725 patients in the per-protocol population. This trial is registered as a clinical trial, EudraCT number 2004-002474-36. Findings The safety profile of the test vaccine was good, and its local tolerability profile was more favourable than that of the licensed vaccine. Frequency of adverse events was similar between treatment groups, and vaccine-related adverse events were generally mild. The seroconversion rate of the test vaccine was 98% compared with 95% for the licensed vaccine on day 56 (95% CI for the difference −1·33 to 3·43). Geometric mean titre for recipients of the test vaccine was 244 (range 5–19 783), compared with 102 (5–1864) for the licensed vaccine (ratio 2·3 [95% CI 1·967–2·75]). 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Although no treatment is currently available, vaccination effectively prevents the disease. In a non-inferiority study, we aimed to compare the safety and immunogenicity of a novel, second-generation, inactivated candidate vaccine for JEV with a licensed, mouse-brain-derived vaccine. Methods We included 867 adults in a multicentre, multinational, observer-blinded, randomised controlled phase III trial. Study sites were located in the USA, Germany, and Austria. Volunteers received either the JEV test vaccine intramuscularly on a two-dose schedule (on days 0 and 28; n=430) or the licensed vaccine subcutaneously according to its recommended three-dose schedule (on days 0, 7, and 28; n=437). The primary endpoint was immunogenicity, with respect to neutralising JEV-specific antibodies assessed by a plaque-reduction neutralisation test, which was assessable in 725 patients in the per-protocol population. This trial is registered as a clinical trial, EudraCT number 2004-002474-36. Findings The safety profile of the test vaccine was good, and its local tolerability profile was more favourable than that of the licensed vaccine. Frequency of adverse events was similar between treatment groups, and vaccine-related adverse events were generally mild. The seroconversion rate of the test vaccine was 98% compared with 95% for the licensed vaccine on day 56 (95% CI for the difference −1·33 to 3·43). Geometric mean titre for recipients of the test vaccine was 244 (range 5–19 783), compared with 102 (5–1864) for the licensed vaccine (ratio 2·3 [95% CI 1·967–2·75]). Interpretation The test JEV vaccine has a promising immunogenicity and safety profile.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>18061060</pmid><doi>10.1016/S0140-6736(07)61780-2</doi><tpages>7</tpages></addata></record>
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identifier ISSN: 0140-6736
ispartof The Lancet (British edition), 2007-12, Vol.370 (9602), p.1847-1853
issn 0140-6736
1474-547X
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recordid cdi_proquest_miscellaneous_69044694
source ScienceDirect Freedom Collection 2022-2024
subjects Adolescent
Adult
Aged
Aged, 80 and over
Analysis of Variance
Animals
Antibodies, Viral - blood
Cercopithecus aethiops
Clinical trials
Encephalitis
Encephalitis, Japanese - immunology
Encephalitis, Japanese - prevention & control
Female
Humans
Immunization Schedule
Immunogenicity
Internal Medicine
Japanese Encephalitis Vaccines - administration & dosage
Japanese Encephalitis Vaccines - adverse effects
Japanese Encephalitis Vaccines - immunology
Japanese encephalitis virus
Male
Middle Aged
Safety
Studies
Vaccines
Vector-borne diseases
Vero Cells
title Safety and immunogenicity of a Vero-cell-derived, inactivated Japanese encephalitis vaccine: a non-inferiority, phase III, randomised controlled trial
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