GrippeCanadaV4, Main, Exploration, bibRecordById, pubmed:25264897

Risk of narcolepsy associated with inactivated adjuvanted (AS03) A/H1N1 (2009) pandemic influenza vaccine in Quebec.

Identifieur interne : 000263 ( Main/Exploration ); précédent : 000262; suivant : 000264

Risk of narcolepsy associated with inactivated adjuvanted (AS03) A/H1N1 (2009) pandemic influenza vaccine in Quebec.

Auteurs : Jacques Montplaisir [Canada] ; Dominique Petit [Canada] ; Marie-Josée Quinn [Canada] ; Manale Ouakki [Canada] ; Geneviève Deceuninck [Canada] ; Alex Desautels [Canada] ; Emmanuel Mignot [États-Unis] ; Philippe De Wals [Canada]

Source :

PloS one [ 1932-6203 ] ; 2014.

RBID : pubmed:25264897

Descripteurs français

KwdFr :
- Adjuvants immunologiques (effets indésirables), Adolescent (MeSH), Adulte (MeSH), Adulte d'âge moyen (MeSH), Association médicamenteuse (MeSH), Enfant (MeSH), Femelle (MeSH), Grippe humaine (immunologie), Grippe humaine (prévention et contrôle), Humains (MeSH), Jeune adulte (MeSH), Mâle (MeSH), Narcolepsie (épidémiologie), Polysorbates (effets indésirables), Polysorbates (usage thérapeutique), Québec (épidémiologie), Sous-type H1N1 du virus de la grippe A (immunologie), Squalène (effets indésirables), Squalène (usage thérapeutique), Vaccination (MeSH), Vaccins antigrippaux (effets indésirables), Vaccins antigrippaux (usage thérapeutique), alpha-Tocophérol (effets indésirables), alpha-Tocophérol (usage thérapeutique), Études cas-témoins (MeSH), Études rétrospectives (MeSH).
MESH :
- effets indésirables : Adjuvants immunologiques, Polysorbates, Squalène, Vaccins antigrippaux, alpha-Tocophérol.
- immunologie : Grippe humaine, Sous-type H1N1 du virus de la grippe A.
- prévention et contrôle : Grippe humaine.
- usage thérapeutique : Polysorbates, Squalène, Vaccins antigrippaux, alpha-Tocophérol.
- épidémiologie : Narcolepsie, Québec.
- Adolescent, Adulte, Adulte d'âge moyen, Association médicamenteuse, Enfant, Femelle, Humains, Jeune adulte, Mâle, Vaccination, Études cas-témoins, Études rétrospectives.

English descriptors

KwdEn :
- Adjuvants, Immunologic (adverse effects), Adolescent (MeSH), Adult (MeSH), Case-Control Studies (MeSH), Child (MeSH), Drug Combinations (MeSH), Female (MeSH), Humans (MeSH), Influenza A Virus, H1N1 Subtype (immunology), Influenza Vaccines (adverse effects), Influenza Vaccines (therapeutic use), Influenza, Human (immunology), Influenza, Human (prevention & control), Male (MeSH), Middle Aged (MeSH), Narcolepsy (epidemiology), Polysorbates (adverse effects), Polysorbates (therapeutic use), Quebec (epidemiology), Retrospective Studies (MeSH), Squalene (adverse effects), Squalene (therapeutic use), Vaccination (MeSH), Young Adult (MeSH), alpha-Tocopherol (adverse effects), alpha-Tocopherol (therapeutic use).
MESH :
- chemical , adverse effects : Adjuvants, Immunologic, Influenza Vaccines, Polysorbates, Squalene, alpha-Tocopherol.
- geographic , epidemiology : Quebec.
- epidemiology : Narcolepsy.
- immunology : Influenza A Virus, H1N1 Subtype, Influenza, Human.
- prevention & control : Influenza, Human.
- chemical , therapeutic use : Influenza Vaccines, Polysorbates, Squalene, alpha-Tocopherol.
- Adolescent, Adult, Case-Control Studies, Child, Drug Combinations, Female, Humans, Male, Middle Aged, Retrospective Studies, Vaccination, Young Adult.

Abstract

CONTEXT

An association between an adjuvanted (AS03) A/H1N1 pandemic vaccine and narcolepsy has been reported in Europe.

OBJECTIVE

To assess narcolepsy risk following administration of a similar vaccine in Quebec.

DESIGN

Retrospective population-based study.

SETTING

Neurologists and lung specialists in the province were invited to report narcolepsy cases to a single reference centre.

POPULATION

Patients were interviewed by two sleep experts and standard diagnostic tests were performed. Immunization status was verified in the provincial pandemic influenza vaccination registry.

MAIN OUTCOME MEASURES

Confirmed narcolepsy with or without cataplexy with onset of excessive daytime sleepiness between January 1st, 2009, and December 31st, 2010. Relative risks (RRs) were calculated using a Poisson model in a cohort analysis, by a self-controlled case series (SCCS) and a case-control method.

RESULTS

A total of 24 cases were included and overall incidence rate was 1.5 per million person-years. A cluster of 7 cases was observed among vaccinated persons in the winter 2009-2010. In the primary cohort analysis, 16-week post-vaccination RR was 4.32 (95% CI: 1.50-11.12). RR was 2.07 (0.70-6.17) in the SCCS, and 1.48 (0.37-7.03) using the case-control method. Estimates were lower when observation was restricted to the period of pandemic influenza circulation, and tended to be higher in persons <20 years old and for cataplexy cases.

CONCLUSIONS

Results are compatible with an excess risk of approximately one case per million vaccine doses, mainly in persons less than 20 years of age. However, a confounding effect of the influenza infection cannot be ruled out.

DOI: 10.1371/journal.pone.0108489
PubMed: 25264897
PubMed Central: PMC4180737

Affiliations:

Links toward previous steps (curation, corpus...)

to stream Main, to step Corpus: 000261
to stream Main, to step Curation: 000261

Le document en format XML

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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adjuvants, Immunologic (adverse effects)</term>
<term>Adolescent (MeSH)</term>
<term>Adult (MeSH)</term>
<term>Case-Control Studies (MeSH)</term>
<term>Child (MeSH)</term>
<term>Drug Combinations (MeSH)</term>
<term>Female (MeSH)</term>
<term>Humans (MeSH)</term>
<term>Influenza A Virus, H1N1 Subtype (immunology)</term>
<term>Influenza Vaccines (adverse effects)</term>
<term>Influenza Vaccines (therapeutic use)</term>
<term>Influenza, Human (immunology)</term>
<term>Influenza, Human (prevention & control)</term>
<term>Male (MeSH)</term>
<term>Middle Aged (MeSH)</term>
<term>Narcolepsy (epidemiology)</term>
<term>Polysorbates (adverse effects)</term>
<term>Polysorbates (therapeutic use)</term>
<term>Quebec (epidemiology)</term>
<term>Retrospective Studies (MeSH)</term>
<term>Squalene (adverse effects)</term>
<term>Squalene (therapeutic use)</term>
<term>Vaccination (MeSH)</term>
<term>Young Adult (MeSH)</term>
<term>alpha-Tocopherol (adverse effects)</term>
<term>alpha-Tocopherol (therapeutic use)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Adjuvants immunologiques (effets indésirables)</term>
<term>Adolescent (MeSH)</term>
<term>Adulte (MeSH)</term>
<term>Adulte d'âge moyen (MeSH)</term>
<term>Association médicamenteuse (MeSH)</term>
<term>Enfant (MeSH)</term>
<term>Femelle (MeSH)</term>
<term>Grippe humaine (immunologie)</term>
<term>Grippe humaine (prévention et contrôle)</term>
<term>Humains (MeSH)</term>
<term>Jeune adulte (MeSH)</term>
<term>Mâle (MeSH)</term>
<term>Narcolepsie (épidémiologie)</term>
<term>Polysorbates (effets indésirables)</term>
<term>Polysorbates (usage thérapeutique)</term>
<term>Québec (épidémiologie)</term>
<term>Sous-type H1N1 du virus de la grippe A (immunologie)</term>
<term>Squalène (effets indésirables)</term>
<term>Squalène (usage thérapeutique)</term>
<term>Vaccination (MeSH)</term>
<term>Vaccins antigrippaux (effets indésirables)</term>
<term>Vaccins antigrippaux (usage thérapeutique)</term>
<term>alpha-Tocophérol (effets indésirables)</term>
<term>alpha-Tocophérol (usage thérapeutique)</term>
<term>Études cas-témoins (MeSH)</term>
<term>Études rétrospectives (MeSH)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Adjuvants, Immunologic</term>
<term>Influenza Vaccines</term>
<term>Polysorbates</term>
<term>Squalene</term>
<term>alpha-Tocopherol</term>
</keywords>
<keywords scheme="MESH" type="geographic" qualifier="epidemiology" xml:lang="en"><term>Quebec</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Adjuvants immunologiques</term>
<term>Polysorbates</term>
<term>Squalène</term>
<term>Vaccins antigrippaux</term>
<term>alpha-Tocophérol</term>
</keywords>
<keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Narcolepsy</term>
</keywords>
<keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Grippe humaine</term>
<term>Sous-type H1N1 du virus de la grippe A</term>
</keywords>
<keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Influenza A Virus, H1N1 Subtype</term>
<term>Influenza, Human</term>
</keywords>
<keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Influenza, Human</term>
</keywords>
<keywords scheme="MESH" qualifier="prévention et contrôle" xml:lang="fr"><term>Grippe humaine</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Influenza Vaccines</term>
<term>Polysorbates</term>
<term>Squalene</term>
<term>alpha-Tocopherol</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Polysorbates</term>
<term>Squalène</term>
<term>Vaccins antigrippaux</term>
<term>alpha-Tocophérol</term>
</keywords>
<keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr"><term>Narcolepsie</term>
<term>Québec</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adolescent</term>
<term>Adult</term>
<term>Case-Control Studies</term>
<term>Child</term>
<term>Drug Combinations</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Retrospective Studies</term>
<term>Vaccination</term>
<term>Young Adult</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Association médicamenteuse</term>
<term>Enfant</term>
<term>Femelle</term>
<term>Humains</term>
<term>Jeune adulte</term>
<term>Mâle</term>
<term>Vaccination</term>
<term>Études cas-témoins</term>
<term>Études rétrospectives</term>
</keywords>
</textClass>
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<front><div type="abstract" xml:lang="en"><p><b>CONTEXT</b>
</p>
<p>An association between an adjuvanted (AS03) A/H1N1 pandemic vaccine and narcolepsy has been reported in Europe.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>OBJECTIVE</b>
</p>
<p>To assess narcolepsy risk following administration of a similar vaccine in Quebec.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>DESIGN</b>
</p>
<p>Retrospective population-based study.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>SETTING</b>
</p>
<p>Neurologists and lung specialists in the province were invited to report narcolepsy cases to a single reference centre.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>POPULATION</b>
</p>
<p>Patients were interviewed by two sleep experts and standard diagnostic tests were performed. Immunization status was verified in the provincial pandemic influenza vaccination registry.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>MAIN OUTCOME MEASURES</b>
</p>
<p>Confirmed narcolepsy with or without cataplexy with onset of excessive daytime sleepiness between January 1st, 2009, and December 31st, 2010. Relative risks (RRs) were calculated using a Poisson model in a cohort analysis, by a self-controlled case series (SCCS) and a case-control method.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>RESULTS</b>
</p>
<p>A total of 24 cases were included and overall incidence rate was 1.5 per million person-years. A cluster of 7 cases was observed among vaccinated persons in the winter 2009-2010. In the primary cohort analysis, 16-week post-vaccination RR was 4.32 (95% CI: 1.50-11.12). RR was 2.07 (0.70-6.17) in the SCCS, and 1.48 (0.37-7.03) using the case-control method. Estimates were lower when observation was restricted to the period of pandemic influenza circulation, and tended to be higher in persons <20 years old and for cataplexy cases.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b>
</p>
<p>Results are compatible with an excess risk of approximately one case per million vaccine doses, mainly in persons less than 20 years of age. However, a confounding effect of the influenza infection cannot be ruled out.</p>
</div>
</front>
</TEI>
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<DateCompleted><Year>2015</Year>
<Month>11</Month>
<Day>16</Day>
</DateCompleted>
<DateRevised><Year>2019</Year>
<Month>02</Month>
<Day>23</Day>
</DateRevised>
<Article PubModel="Electronic-eCollection"><Journal><ISSN IssnType="Electronic">1932-6203</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>9</Volume>
<Issue>9</Issue>
<PubDate><Year>2014</Year>
</PubDate>
</JournalIssue>
<Title>PloS one</Title>
<ISOAbbreviation>PLoS ONE</ISOAbbreviation>
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<ArticleTitle>Risk of narcolepsy associated with inactivated adjuvanted (AS03) A/H1N1 (2009) pandemic influenza vaccine in Quebec.</ArticleTitle>
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<ELocationID EIdType="doi" ValidYN="Y">10.1371/journal.pone.0108489</ELocationID>
<Abstract><AbstractText Label="CONTEXT" NlmCategory="BACKGROUND">An association between an adjuvanted (AS03) A/H1N1 pandemic vaccine and narcolepsy has been reported in Europe.</AbstractText>
<AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">To assess narcolepsy risk following administration of a similar vaccine in Quebec.</AbstractText>
<AbstractText Label="DESIGN" NlmCategory="METHODS">Retrospective population-based study.</AbstractText>
<AbstractText Label="SETTING" NlmCategory="METHODS">Neurologists and lung specialists in the province were invited to report narcolepsy cases to a single reference centre.</AbstractText>
<AbstractText Label="POPULATION" NlmCategory="METHODS">Patients were interviewed by two sleep experts and standard diagnostic tests were performed. Immunization status was verified in the provincial pandemic influenza vaccination registry.</AbstractText>
<AbstractText Label="MAIN OUTCOME MEASURES" NlmCategory="METHODS">Confirmed narcolepsy with or without cataplexy with onset of excessive daytime sleepiness between January 1st, 2009, and December 31st, 2010. Relative risks (RRs) were calculated using a Poisson model in a cohort analysis, by a self-controlled case series (SCCS) and a case-control method.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">A total of 24 cases were included and overall incidence rate was 1.5 per million person-years. A cluster of 7 cases was observed among vaccinated persons in the winter 2009-2010. In the primary cohort analysis, 16-week post-vaccination RR was 4.32 (95% CI: 1.50-11.12). RR was 2.07 (0.70-6.17) in the SCCS, and 1.48 (0.37-7.03) using the case-control method. Estimates were lower when observation was restricted to the period of pandemic influenza circulation, and tended to be higher in persons <20 years old and for cataplexy cases.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Results are compatible with an excess risk of approximately one case per million vaccine doses, mainly in persons less than 20 years of age. However, a confounding effect of the influenza infection cannot be ruled out.</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Montplaisir</LastName>
<ForeName>Jacques</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Centre for Advanced Research in Sleep Medicine, Hôpital du Sacré-Coeur, and Department of Psychiatry, University of Montreal, Montreal, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Petit</LastName>
<ForeName>Dominique</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Centre for Advanced Research in Sleep Medicine, Hôpital du Sacré-Coeur, Montreal, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Quinn</LastName>
<ForeName>Marie-Josée</ForeName>
<Initials>MJ</Initials>
<AffiliationInfo><Affiliation>Centre for Advanced Research in Sleep Medicine, Hôpital du Sacré-Coeur, Montreal, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ouakki</LastName>
<ForeName>Manale</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Quebec National Public Health Institute (Institut national de santé publique du Québec), Quebec City, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Deceuninck</LastName>
<ForeName>Geneviève</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>Quebec University Hospital Research Centre, Quebec City, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Desautels</LastName>
<ForeName>Alex</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Centre for Advanced Research in Sleep Medicine, Hôpital du Sacré-Coeur, and Department of Medicine, University of Montreal, Montreal, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Mignot</LastName>
<ForeName>Emmanuel</ForeName>
<Initials>E</Initials>
<AffiliationInfo><Affiliation>Stanford Center for Sleep Sciences and Medicine, Stanford University of Medicine, Palo Alto, CA, United States of America.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>De Wals</LastName>
<ForeName>Philippe</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Department of Social and Preventive Medicine, Laval University, Quebec City, Canada.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
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<PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2014</Year>
<Month>09</Month>
<Day>29</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>United States</Country>
<MedlineTA>PLoS One</MedlineTA>
<NlmUniqueID>101285081</NlmUniqueID>
<ISSNLinking>1932-6203</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList><Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="C550253">ASO3B adjuvant</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D000276">Adjuvants, Immunologic</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D004338">Drug Combinations</NameOfSubstance>
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<MeshHeadingList><MeshHeading><DescriptorName UI="D000276" MajorTopicYN="N">Adjuvants, Immunologic</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D016022" MajorTopicYN="N">Case-Control Studies</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D002648" MajorTopicYN="N">Child</DescriptorName>
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<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
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Risk of narcolepsy associated with inactivated adjuvanted (AS03) A/H1N1 (2009) pandemic influenza vaccine in Quebec.

Risk of narcolepsy associated with inactivated adjuvanted (AS03) A/H1N1 (2009) pandemic influenza vaccine in Quebec.

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