Immunogenicity and safety of the inactivated Japanese encephalitis vaccine IXIARO® in elderly subjects: Open-label, uncontrolled, multi-center, phase 4 study.
Identifieur interne : 000086 ( Main/Exploration ); précédent : 000085; suivant : 000087Immunogenicity and safety of the inactivated Japanese encephalitis vaccine IXIARO® in elderly subjects: Open-label, uncontrolled, multi-center, phase 4 study.
Auteurs : Jakob P. Cramer [Allemagne] ; Katrin Dubischar [Autriche] ; Susanne Eder [Autriche] ; Gerd D. Burchard [Allemagne] ; Tomas Jelinek [Allemagne] ; Bernd Jilma [Autriche] ; Herwig Kollaritsch [Autriche] ; Emil Reisinger [Allemagne] ; Kerstin Westritschnig [Autriche]Source :
- Vaccine [ 1873-2518 ] ; 2016.
Descripteurs français
- KwdFr :
- Allemagne, Anticorps antiviraux (sang), Autriche, Encéphalite japonaise (), Femelle, Humains, Immunogénicité des vaccins, Mâle, Rappel de vaccin, Sujet âgé, Sujet âgé de 80 ans ou plus, Séroconversion, Vaccins contre l'encéphalite japonaise (effets indésirables), Vaccins contre l'encéphalite japonaise (immunologie), Vaccins contre l'encéphalite japonaise (usage thérapeutique), Études prospectives.
- MESH :
- effets indésirables : Vaccins contre l'encéphalite japonaise.
- immunologie : Vaccins contre l'encéphalite japonaise.
- sang : Anticorps antiviraux.
- usage thérapeutique : Vaccins contre l'encéphalite japonaise.
- Allemagne, Autriche, Encéphalite japonaise, Femelle, Humains, Immunogénicité des vaccins, Mâle, Rappel de vaccin, Sujet âgé, Sujet âgé de 80 ans ou plus, Séroconversion, Études prospectives.
English descriptors
- KwdEn :
- Aged, Aged, 80 and over, Antibodies, Viral (blood), Austria, Encephalitis, Japanese (prevention & control), Female, Germany, Humans, Immunization, Secondary, Immunogenicity, Vaccine, Japanese Encephalitis Vaccines (adverse effects), Japanese Encephalitis Vaccines (immunology), Japanese Encephalitis Vaccines (therapeutic use), Male, Prospective Studies, Seroconversion.
- MESH :
- chemical , adverse effects : Japanese Encephalitis Vaccines.
- chemical , blood : Antibodies, Viral.
- chemical , immunology : Japanese Encephalitis Vaccines.
- prevention & control : Encephalitis, Japanese.
- chemical , therapeutic use : Japanese Encephalitis Vaccines.
- Aged, Aged, 80 and over, Austria, Female, Germany, Humans, Immunization, Secondary, Immunogenicity, Vaccine, Male, Prospective Studies, Seroconversion.
Abstract
IXIARO® is a Vero cell-derived, inactivated Japanese encephalitis (JE) vaccine licensed mainly in western countries for children and adults traveling to JE endemic areas. Limited immunogenicity and safety data in elderly travelers have been available.
DOI: 10.1016/j.vaccine.2016.07.029
PubMed: 27460550
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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<term>Aged, 80 and over</term>
<term>Antibodies, Viral (blood)</term>
<term>Austria</term>
<term>Encephalitis, Japanese (prevention & control)</term>
<term>Female</term>
<term>Germany</term>
<term>Humans</term>
<term>Immunization, Secondary</term>
<term>Immunogenicity, Vaccine</term>
<term>Japanese Encephalitis Vaccines (adverse effects)</term>
<term>Japanese Encephalitis Vaccines (immunology)</term>
<term>Japanese Encephalitis Vaccines (therapeutic use)</term>
<term>Male</term>
<term>Prospective Studies</term>
<term>Seroconversion</term>
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<term>Anticorps antiviraux (sang)</term>
<term>Autriche</term>
<term>Encéphalite japonaise ()</term>
<term>Femelle</term>
<term>Humains</term>
<term>Immunogénicité des vaccins</term>
<term>Mâle</term>
<term>Rappel de vaccin</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
<term>Séroconversion</term>
<term>Vaccins contre l'encéphalite japonaise (effets indésirables)</term>
<term>Vaccins contre l'encéphalite japonaise (immunologie)</term>
<term>Vaccins contre l'encéphalite japonaise (usage thérapeutique)</term>
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<term>Aged, 80 and over</term>
<term>Austria</term>
<term>Female</term>
<term>Germany</term>
<term>Humans</term>
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<term>Autriche</term>
<term>Encéphalite japonaise</term>
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<term>Humains</term>
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<term>Rappel de vaccin</term>
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<front><div type="abstract" xml:lang="en">IXIARO® is a Vero cell-derived, inactivated Japanese encephalitis (JE) vaccine licensed mainly in western countries for children and adults traveling to JE endemic areas. Limited immunogenicity and safety data in elderly travelers have been available.</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">27460550</PMID>
<DateCompleted><Year>2017</Year>
<Month>11</Month>
<Day>13</Day>
</DateCompleted>
<DateRevised><Year>2017</Year>
<Month>12</Month>
<Day>06</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-2518</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>34</Volume>
<Issue>38</Issue>
<PubDate><Year>2016</Year>
<Month>08</Month>
<Day>31</Day>
</PubDate>
</JournalIssue>
<Title>Vaccine</Title>
<ISOAbbreviation>Vaccine</ISOAbbreviation>
</Journal>
<ArticleTitle>Immunogenicity and safety of the inactivated Japanese encephalitis vaccine IXIARO® in elderly subjects: Open-label, uncontrolled, multi-center, phase 4 study.</ArticleTitle>
<Pagination><MedlinePgn>4579-4585</MedlinePgn>
</Pagination>
<ELocationID EIdType="pii" ValidYN="Y">S0264-410X(16)30612-0</ELocationID>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.vaccine.2016.07.029</ELocationID>
<Abstract><AbstractText Label="BACKGROUND">IXIARO® is a Vero cell-derived, inactivated Japanese encephalitis (JE) vaccine licensed mainly in western countries for children and adults traveling to JE endemic areas. Limited immunogenicity and safety data in elderly travelers have been available.</AbstractText>
<AbstractText Label="OBJECTIVES">To evaluate safety and immunogenicity of IXIARO in elderly subjects.</AbstractText>
<AbstractText Label="METHODS">Open-label, single arm, multi-centered study. Two-hundred subjects with good general health, including adequately controlled chronic conditions, received two doses of IXIARO®, 28days apart. Protective levels of antibodies were tested 42days after the second dose. Systemic and local adverse events (AEs) were solicited for 7days after each dose, unsolicited AEs were collected up to day 70 and in a phone call at month 7.</AbstractText>
<AbstractText Label="SUMMARY OF RESULTS">Subjects were aged 64-83years (median 69.0years). Nineteen percent of subjects had serious or medically attended AEs up to Day 70 (primary endpoint), none of them causally linked to IXIARO. Solicited local AEs were reported by 33.5% (most common: local tenderness) and solicited systemic AEs by 27% (most common: headache) of subjects. The seroprotection rate was 65% with a geometric mean titre (GMT) of 37. Subjects with tick borne encephalitis (TBE) vaccinations in the past 5years (N=29) had a SCR of 90% and GMT of 65.</AbstractText>
<AbstractText Label="CONCLUSIONS">IXIARO is generally well tolerated in the elderly, and the safety profile is largely comparable with younger adults. SCR and GMT are lower compared to younger adults, but SCR is in the range reported in elderly for other vaccines e.g. against TBE, hepatitis-A virus (HAV)/hepatitis-B virus (HBV), influenza. The differences in SCR and GMT from younger to elderly adults were in the range of other vaccines. Duration of protection is uncertain in older persons, therefore a booster dose (third dose) should be considered before any further exposure to JE virus.</AbstractText>
<CopyrightInformation>Copyright © 2016. Published by Elsevier Ltd.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Cramer</LastName>
<ForeName>Jakob P</ForeName>
<Initials>JP</Initials>
<AffiliationInfo><Affiliation>Bernhard Nocht Centre for Clinical Trials, Section Tropical Medicine/Infectious Diseases, I. Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany(1); Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Dubischar</LastName>
<ForeName>Katrin</ForeName>
<Initials>K</Initials>
<AffiliationInfo><Affiliation>Valneva Austria GmbH, Campus Vienna Biocenter 3, 1030 Vienna, Austria. Electronic address: Katrin.dubischar@valneva.com.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Eder</LastName>
<ForeName>Susanne</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Valneva Austria GmbH, Campus Vienna Biocenter 3, 1030 Vienna, Austria.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Burchard</LastName>
<ForeName>Gerd D</ForeName>
<Initials>GD</Initials>
<AffiliationInfo><Affiliation>Bernhard Nocht Centre for Clinical Trials, Section Tropical Medicine/Infectious Diseases, I. Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany(1); Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Jelinek</LastName>
<ForeName>Tomas</ForeName>
<Initials>T</Initials>
<AffiliationInfo><Affiliation>Berlin Center for Travel & Tropical Medicine, Berlin, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Jilma</LastName>
<ForeName>Bernd</ForeName>
<Initials>B</Initials>
<AffiliationInfo><Affiliation>Department of Clinical Pharmacology, Medical University of Vienna, Austria.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Kollaritsch</LastName>
<ForeName>Herwig</ForeName>
<Initials>H</Initials>
<AffiliationInfo><Affiliation>Institute of Specific Prophylaxis and Tropical Medicine, Center for Pathophysiology, Infectiology and Immunology, Medical University of Vienna, Austria.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Reisinger</LastName>
<ForeName>Emil</ForeName>
<Initials>E</Initials>
<AffiliationInfo><Affiliation>Department of Tropical Medicine & Infectious Diseases, Rostock University Medical Center, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Westritschnig</LastName>
<ForeName>Kerstin</ForeName>
<Initials>K</Initials>
<AffiliationInfo><Affiliation>Valneva Austria GmbH, Campus Vienna Biocenter 3, 1030 Vienna, Austria.</Affiliation>
</AffiliationInfo>
</Author>
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<Language>eng</Language>
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<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016448">Multicenter Study</PublicationType>
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<ArticleDate DateType="Electronic"><Year>2016</Year>
<Month>07</Month>
<Day>25</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>Netherlands</Country>
<MedlineTA>Vaccine</MedlineTA>
<NlmUniqueID>8406899</NlmUniqueID>
<ISSNLinking>0264-410X</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList><Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D000914">Antibodies, Viral</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D022321">Japanese Encephalitis Vaccines</NameOfSubstance>
</Chemical>
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<MeshHeadingList><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName>
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<MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName>
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<MeshHeading><DescriptorName UI="D001317" MajorTopicYN="N">Austria</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D004672" MajorTopicYN="N">Encephalitis, Japanese</DescriptorName>
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</MeshHeading>
<MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
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<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
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</MeshHeading>
<MeshHeading><DescriptorName UI="D000071497" MajorTopicYN="Y">Immunogenicity, Vaccine</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D022321" MajorTopicYN="N">Japanese Encephalitis Vaccines</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName>
<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
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<MeshHeading><DescriptorName UI="D000069078" MajorTopicYN="N">Seroconversion</DescriptorName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">Elderly</Keyword>
<Keyword MajorTopicYN="Y">Immunogenicity</Keyword>
<Keyword MajorTopicYN="Y">Japanese encephalitis</Keyword>
<Keyword MajorTopicYN="Y">Safety</Keyword>
<Keyword MajorTopicYN="Y">Vaccine</Keyword>
</KeywordList>
</MedlineCitation>
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<Month>04</Month>
<Day>27</Day>
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<PubMedPubDate PubStatus="revised"><Year>2016</Year>
<Month>07</Month>
<Day>06</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted"><Year>2016</Year>
<Month>07</Month>
<Day>15</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="entrez"><Year>2016</Year>
<Month>7</Month>
<Day>28</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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<PubMedPubDate PubStatus="pubmed"><Year>2016</Year>
<Month>7</Month>
<Day>28</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="medline"><Year>2017</Year>
<Month>11</Month>
<Day>14</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
</History>
<PublicationStatus>ppublish</PublicationStatus>
<ArticleIdList><ArticleId IdType="pubmed">27460550</ArticleId>
<ArticleId IdType="pii">S0264-410X(16)30612-0</ArticleId>
<ArticleId IdType="doi">10.1016/j.vaccine.2016.07.029</ArticleId>
</ArticleIdList>
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</pubmed>
<affiliations><list><country><li>Allemagne</li>
<li>Autriche</li>
</country>
<region><li>Berlin</li>
<li>Hambourg</li>
<li>Vienne (Autriche)</li>
</region>
<settlement><li>Berlin</li>
<li>Hambourg</li>
<li>Vienne (Autriche)</li>
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<tree><country name="Allemagne"><region name="Hambourg"><name sortKey="Cramer, Jakob P" sort="Cramer, Jakob P" uniqKey="Cramer J" first="Jakob P" last="Cramer">Jakob P. Cramer</name>
</region>
<name sortKey="Burchard, Gerd D" sort="Burchard, Gerd D" uniqKey="Burchard G" first="Gerd D" last="Burchard">Gerd D. Burchard</name>
<name sortKey="Jelinek, Tomas" sort="Jelinek, Tomas" uniqKey="Jelinek T" first="Tomas" last="Jelinek">Tomas Jelinek</name>
<name sortKey="Reisinger, Emil" sort="Reisinger, Emil" uniqKey="Reisinger E" first="Emil" last="Reisinger">Emil Reisinger</name>
</country>
<country name="Autriche"><region name="Vienne (Autriche)"><name sortKey="Dubischar, Katrin" sort="Dubischar, Katrin" uniqKey="Dubischar K" first="Katrin" last="Dubischar">Katrin Dubischar</name>
</region>
<name sortKey="Eder, Susanne" sort="Eder, Susanne" uniqKey="Eder S" first="Susanne" last="Eder">Susanne Eder</name>
<name sortKey="Jilma, Bernd" sort="Jilma, Bernd" uniqKey="Jilma B" first="Bernd" last="Jilma">Bernd Jilma</name>
<name sortKey="Kollaritsch, Herwig" sort="Kollaritsch, Herwig" uniqKey="Kollaritsch H" first="Herwig" last="Kollaritsch">Herwig Kollaritsch</name>
<name sortKey="Westritschnig, Kerstin" sort="Westritschnig, Kerstin" uniqKey="Westritschnig K" first="Kerstin" last="Westritschnig">Kerstin Westritschnig</name>
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