Increased risk of narcolepsy in children and adults after pandemic H1N1 vaccination in France
Identifieur interne : 000253 ( PascalFrancis/Corpus ); précédent : 000252; suivant : 000254Increased risk of narcolepsy in children and adults after pandemic H1N1 vaccination in France
Auteurs : Yves Dauvilliers ; Isabelle Arnulf ; Michel Lecendreux ; Christelle Monaca Charley ; Patricia Franco ; Xavier Drouot ; Marie-Pia D'Ortho ; Sandrine Launois ; Séverine Lignot ; Patrice Bourgin ; Béatrice Nogues ; Marc Rey ; Sophie Bayard ; Sabine Scholz ; Sophie Lavault ; Pascale Tubert-Bitter ; Cristel Saussier ; Antoine ParienteSource :
- Brain [ 0006-8950 ] ; 2013.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
Abstract
An increased incidence of narcolepsy in children was detected in Scandinavian countries where pandemic H1N1 influenza ASO3-adjuvanted vaccine was used. A campaign of vaccination against pandemic H1N1 influenza was implemented in France using both AS03-adjuvanted and non-adjuvanted vaccines. As part of a study considering all-type narcolepsy, we investigated the association between H1N1 vaccination and narcolepsy with cataplexy in children and adults compared with matched controls; and compared the phenotype of narcolepsy with cataplexy according to exposure to the H1N1 vaccination. Patients with narcolepsy-cataplexy were included from 14 expert centres in France. Date of diagnosis constituted the index date. Validation of cases was performed by independent experts using the Brighton collaboration criteria. Up to four controls were individually matched to cases according to age, gender and geographic location. A structured telephone interview was performed to collect information on medical history, past infections and vaccinations. Eighty-five cases with narcolepsy-cataplexy were included; 23 being further excluded regarding eligibility criteria. Of the 62 eligible cases, 59 (64% males, 57.6% children) could be matched with 135 control subjects. H1N1 vaccination was associated with narcolepsy-cataplexy with an odds ratio of 6.5 (2.1-19.9) in subjects aged <18 years, and 4.7 (1.6-13.9) in those aged 18 and over. Sensitivity analyses considering date of referral for diagnosis or the date of onset of symptoms as the index date gave similar results, as did analyses focusing only on exposure to AS03-adjuvanted vaccine. Slight differences were found when comparing cases with narcolepsy-cataplexy exposed to H1N1 vaccination (n = 32; mostly AS03-adjuvanted vaccine, n = 28) to non-exposed cases (n = 30), including shorter delay of diagnosis and a higher number of sleep onset rapid eye movement periods for exposed cases. No difference was found regarding history of infections. In this sub-analysis, H1N1 vaccination was strongly associated with an increased risk of narcolepsy-cataplexy in both children and adults in France. Even if, as in every observational study, the possibility that some biases participated in the association cannot be completely ruled out, the associations appeared robust to sensitivity analyses, and a specific analysis focusing on AS03-adjuvanted vaccine found similar increase.
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NO : | PASCAL 13-0247443 INIST |
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ET : | Increased risk of narcolepsy in children and adults after pandemic H1N1 vaccination in France |
AU : | DAUVILLIERS (Yves); ARNULF (Isabelle); LECENDREUX (Michel); MONACA CHARLEY (Christelle); FRANCO (Patricia); DROUOT (Xavier); D'ORTHO (Marie-Pia); LAUNOIS (Sandrine); LIGNOT (Séverine); BOURGIN (Patrice); NOGUES (Béatrice); REY (Marc); BAYARD (Sophie); SCHOLZ (Sabine); LAVAULT (Sophie); TUBERT-BITTER (Pascale); SAUSSIER (Cristel); PARIENTE (Antoine) |
AF : | Sleep Disorder Centre, Neurology Department, Gui de Chauliac hospital, CHU Montpellier, INSERM, U1061/Montpellier/France (1 aut., 13 aut., 14 aut.); National Reference Network for Orphan Diseases (Narcolepsy, Idiopathic Hypersomnia and Kleine Levin syndrome)/France (1 aut., 2 aut., 3 aut., 5 aut., 13 aut., 14 aut., 15 aut.); Sleep Disorder Unit, Hospital la Pitié-Salpêtrière, AP-HP/Paris/France (2 aut., 15 aut.); Paediatric Sleep Disorder Centre, CHU Robert-Debré, AP-HP/Paris/France (3 aut.); Sleep Unit, Clinical Neurophysiology Department, Université Lille Nord de France; Lille University Hospital/Lille/France (4 aut.); INSERM, U1028, Lyon, France; Paediatric Sleep Unit, Hôpital Femme-Mère-Enfant/Lyon/France (5 aut.); Sleep Centre Physiology Department, Functional Explorations, Hôpital Henri Mondor/Creteil/France (6 aut.); Sleep Centre - Neurophysiology, Department of Physiology, Functional Explorations, Bichat Hospital, AP-HP, Université Denis Diderot Paris 7Paris/France (7 aut.); Sleep Laboratory and Physiology Department, Grenoble University Hospital, Inserm, U1042/Grenoble/France (8 aut.); Inserm, CIC-P 0005, Pharmacoepidemiology Department, CHU de Bordeaux/France (9 aut., 18 aut.); Sleep Disorder Centre, CHU Strasbourg, CNRS UPR 3212/Strasbourg/France (10 aut.); Functional Explorations Laboratory, Rare Hypersomnia Competence Centre, Hôpital Laennec/Nantes/France (11 aut.); Clinical Neurophysiology Unit, La Timone Hospital/Marseille/France (12 aut.); INSERM, U1018, Centre for Research in Epidemiology and Population Health (CESP), Biostatistics Team, Villejuif, France. Univ Paris Sud, UMRS 1018/Villejuif/France (16 aut.); Agence Nationale de Sécurité des Medicaments et des Produits de Santé/Saint-Denis/France (17 aut.) |
DT : | Publication en série; Niveau analytique |
SO : | Brain; ISSN 0006-8950; Royaume-Uni; Da. 2013; Vol. 136; No. p. 8; Pp. 2486-2496; Bibl. 3/4 p. |
LA : | Anglais |
EA : | An increased incidence of narcolepsy in children was detected in Scandinavian countries where pandemic H1N1 influenza ASO3-adjuvanted vaccine was used. A campaign of vaccination against pandemic H1N1 influenza was implemented in France using both AS03-adjuvanted and non-adjuvanted vaccines. As part of a study considering all-type narcolepsy, we investigated the association between H1N1 vaccination and narcolepsy with cataplexy in children and adults compared with matched controls; and compared the phenotype of narcolepsy with cataplexy according to exposure to the H1N1 vaccination. Patients with narcolepsy-cataplexy were included from 14 expert centres in France. Date of diagnosis constituted the index date. Validation of cases was performed by independent experts using the Brighton collaboration criteria. Up to four controls were individually matched to cases according to age, gender and geographic location. A structured telephone interview was performed to collect information on medical history, past infections and vaccinations. Eighty-five cases with narcolepsy-cataplexy were included; 23 being further excluded regarding eligibility criteria. Of the 62 eligible cases, 59 (64% males, 57.6% children) could be matched with 135 control subjects. H1N1 vaccination was associated with narcolepsy-cataplexy with an odds ratio of 6.5 (2.1-19.9) in subjects aged <18 years, and 4.7 (1.6-13.9) in those aged 18 and over. Sensitivity analyses considering date of referral for diagnosis or the date of onset of symptoms as the index date gave similar results, as did analyses focusing only on exposure to AS03-adjuvanted vaccine. Slight differences were found when comparing cases with narcolepsy-cataplexy exposed to H1N1 vaccination (n = 32; mostly AS03-adjuvanted vaccine, n = 28) to non-exposed cases (n = 30), including shorter delay of diagnosis and a higher number of sleep onset rapid eye movement periods for exposed cases. No difference was found regarding history of infections. In this sub-analysis, H1N1 vaccination was strongly associated with an increased risk of narcolepsy-cataplexy in both children and adults in France. Even if, as in every observational study, the possibility that some biases participated in the association cannot be completely ruled out, the associations appeared robust to sensitivity analyses, and a specific analysis focusing on AS03-adjuvanted vaccine found similar increase. |
CC : | 002B17; 002B17G |
FD : | Narcolepsie; Infection; Pathologie du système nerveux; Facteur risque; Enfant; Vaccination; France; Cataplexie; Prévention; Vaccin; Grippe H1N1 |
FG : | Homme; Europe; Trouble neurologique; Trouble du sommeil; Pathologie de l'appareil respiratoire; Virose |
ED : | Narcolepsy; Infection; Nervous system diseases; Risk factor; Child; Vaccination; France; Cataplexy; Prevention; Vaccine; H1N1 influenza |
EG : | Human; Europe; Neurological disorder; Sleep disorder; Respiratory disease; Viral disease |
SD : | Narcolepsia; Infección; Sistema nervioso patología; Factor riesgo; Niño; Vacunación; Francia; Cataplexia; Prevención; Vacuna; Gripe H1N1 |
LO : | INIST-998.354000506516950140 |
ID : | 13-0247443 |
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Pascal:13-0247443Le document en format XML
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<author><name sortKey="Rey, Marc" sort="Rey, Marc" uniqKey="Rey M" first="Marc" last="Rey">Marc Rey</name>
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<author><name sortKey="Bayard, Sophie" sort="Bayard, Sophie" uniqKey="Bayard S" first="Sophie" last="Bayard">Sophie Bayard</name>
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<author><name sortKey="Scholz, Sabine" sort="Scholz, Sabine" uniqKey="Scholz S" first="Sabine" last="Scholz">Sabine Scholz</name>
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<author><name sortKey="Lavault, Sophie" sort="Lavault, Sophie" uniqKey="Lavault S" first="Sophie" last="Lavault">Sophie Lavault</name>
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<author><name sortKey="Tubert Bitter, Pascale" sort="Tubert Bitter, Pascale" uniqKey="Tubert Bitter P" first="Pascale" last="Tubert-Bitter">Pascale Tubert-Bitter</name>
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<author><name sortKey="Saussier, Cristel" sort="Saussier, Cristel" uniqKey="Saussier C" first="Cristel" last="Saussier">Cristel Saussier</name>
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<author><name sortKey="Pariente, Antoine" sort="Pariente, Antoine" uniqKey="Pariente A" first="Antoine" last="Pariente">Antoine Pariente</name>
<affiliation><inist:fA14 i1="10"><s1>Inserm, CIC-P 0005, Pharmacoepidemiology Department, CHU de Bordeaux</s1>
<s3>FRA</s3>
<sZ>9 aut.</sZ>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Increased risk of narcolepsy in children and adults after pandemic H1N1 vaccination in France</title>
<author><name sortKey="Dauvilliers, Yves" sort="Dauvilliers, Yves" uniqKey="Dauvilliers Y" first="Yves" last="Dauvilliers">Yves Dauvilliers</name>
<affiliation><inist:fA14 i1="01"><s1>Sleep Disorder Centre, Neurology Department, Gui de Chauliac hospital, CHU Montpellier, INSERM, U1061</s1>
<s2>Montpellier</s2>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
</affiliation>
<affiliation><inist:fA14 i1="02"><s1>National Reference Network for Orphan Diseases (Narcolepsy, Idiopathic Hypersomnia and Kleine Levin syndrome)</s1>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
<sZ>13 aut.</sZ>
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<author><name sortKey="Arnulf, Isabelle" sort="Arnulf, Isabelle" uniqKey="Arnulf I" first="Isabelle" last="Arnulf">Isabelle Arnulf</name>
<affiliation><inist:fA14 i1="02"><s1>National Reference Network for Orphan Diseases (Narcolepsy, Idiopathic Hypersomnia and Kleine Levin syndrome)</s1>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
</affiliation>
<affiliation><inist:fA14 i1="03"><s1>Sleep Disorder Unit, Hospital la Pitié-Salpêtrière, AP-HP</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>2 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Lecendreux, Michel" sort="Lecendreux, Michel" uniqKey="Lecendreux M" first="Michel" last="Lecendreux">Michel Lecendreux</name>
<affiliation><inist:fA14 i1="02"><s1>National Reference Network for Orphan Diseases (Narcolepsy, Idiopathic Hypersomnia and Kleine Levin syndrome)</s1>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
</affiliation>
<affiliation><inist:fA14 i1="04"><s1>Paediatric Sleep Disorder Centre, CHU Robert-Debré, AP-HP</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Monaca Charley, Christelle" sort="Monaca Charley, Christelle" uniqKey="Monaca Charley C" first="Christelle" last="Monaca Charley">Christelle Monaca Charley</name>
<affiliation><inist:fA14 i1="05"><s1>Sleep Unit, Clinical Neurophysiology Department, Université Lille Nord de France; Lille University Hospital</s1>
<s2>Lille</s2>
<s3>FRA</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Franco, Patricia" sort="Franco, Patricia" uniqKey="Franco P" first="Patricia" last="Franco">Patricia Franco</name>
<affiliation><inist:fA14 i1="02"><s1>National Reference Network for Orphan Diseases (Narcolepsy, Idiopathic Hypersomnia and Kleine Levin syndrome)</s1>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
</affiliation>
<affiliation><inist:fA14 i1="06"><s1>INSERM, U1028, Lyon, France; Paediatric Sleep Unit, Hôpital Femme-Mère-Enfant</s1>
<s2>Lyon</s2>
<s3>FRA</s3>
<sZ>5 aut.</sZ>
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<author><name sortKey="Drouot, Xavier" sort="Drouot, Xavier" uniqKey="Drouot X" first="Xavier" last="Drouot">Xavier Drouot</name>
<affiliation><inist:fA14 i1="07"><s1>Sleep Centre Physiology Department, Functional Explorations, Hôpital Henri Mondor</s1>
<s2>Creteil</s2>
<s3>FRA</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="D Ortho, Marie Pia" sort="D Ortho, Marie Pia" uniqKey="D Ortho M" first="Marie-Pia" last="D'Ortho">Marie-Pia D'Ortho</name>
<affiliation><inist:fA14 i1="08"><s1>Sleep Centre - Neurophysiology, Department of Physiology, Functional Explorations, Bichat Hospital, AP-HP, Université Denis Diderot Paris 7Paris</s1>
<s3>FRA</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Launois, Sandrine" sort="Launois, Sandrine" uniqKey="Launois S" first="Sandrine" last="Launois">Sandrine Launois</name>
<affiliation><inist:fA14 i1="09"><s1>Sleep Laboratory and Physiology Department, Grenoble University Hospital, Inserm, U1042</s1>
<s2>Grenoble</s2>
<s3>FRA</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Lignot, Severine" sort="Lignot, Severine" uniqKey="Lignot S" first="Séverine" last="Lignot">Séverine Lignot</name>
<affiliation><inist:fA14 i1="10"><s1>Inserm, CIC-P 0005, Pharmacoepidemiology Department, CHU de Bordeaux</s1>
<s3>FRA</s3>
<sZ>9 aut.</sZ>
<sZ>18 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Bourgin, Patrice" sort="Bourgin, Patrice" uniqKey="Bourgin P" first="Patrice" last="Bourgin">Patrice Bourgin</name>
<affiliation><inist:fA14 i1="11"><s1>Sleep Disorder Centre, CHU Strasbourg, CNRS UPR 3212</s1>
<s2>Strasbourg</s2>
<s3>FRA</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Nogues, Beatrice" sort="Nogues, Beatrice" uniqKey="Nogues B" first="Béatrice" last="Nogues">Béatrice Nogues</name>
<affiliation><inist:fA14 i1="12"><s1>Functional Explorations Laboratory, Rare Hypersomnia Competence Centre, Hôpital Laennec</s1>
<s2>Nantes</s2>
<s3>FRA</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Rey, Marc" sort="Rey, Marc" uniqKey="Rey M" first="Marc" last="Rey">Marc Rey</name>
<affiliation><inist:fA14 i1="13"><s1>Clinical Neurophysiology Unit, La Timone Hospital</s1>
<s2>Marseille</s2>
<s3>FRA</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Bayard, Sophie" sort="Bayard, Sophie" uniqKey="Bayard S" first="Sophie" last="Bayard">Sophie Bayard</name>
<affiliation><inist:fA14 i1="01"><s1>Sleep Disorder Centre, Neurology Department, Gui de Chauliac hospital, CHU Montpellier, INSERM, U1061</s1>
<s2>Montpellier</s2>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
</affiliation>
<affiliation><inist:fA14 i1="02"><s1>National Reference Network for Orphan Diseases (Narcolepsy, Idiopathic Hypersomnia and Kleine Levin syndrome)</s1>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Scholz, Sabine" sort="Scholz, Sabine" uniqKey="Scholz S" first="Sabine" last="Scholz">Sabine Scholz</name>
<affiliation><inist:fA14 i1="01"><s1>Sleep Disorder Centre, Neurology Department, Gui de Chauliac hospital, CHU Montpellier, INSERM, U1061</s1>
<s2>Montpellier</s2>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
</affiliation>
<affiliation><inist:fA14 i1="02"><s1>National Reference Network for Orphan Diseases (Narcolepsy, Idiopathic Hypersomnia and Kleine Levin syndrome)</s1>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Lavault, Sophie" sort="Lavault, Sophie" uniqKey="Lavault S" first="Sophie" last="Lavault">Sophie Lavault</name>
<affiliation><inist:fA14 i1="02"><s1>National Reference Network for Orphan Diseases (Narcolepsy, Idiopathic Hypersomnia and Kleine Levin syndrome)</s1>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
</affiliation>
<affiliation><inist:fA14 i1="03"><s1>Sleep Disorder Unit, Hospital la Pitié-Salpêtrière, AP-HP</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>2 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Tubert Bitter, Pascale" sort="Tubert Bitter, Pascale" uniqKey="Tubert Bitter P" first="Pascale" last="Tubert-Bitter">Pascale Tubert-Bitter</name>
<affiliation><inist:fA14 i1="14"><s1>INSERM, U1018, Centre for Research in Epidemiology and Population Health (CESP), Biostatistics Team, Villejuif, France. Univ Paris Sud, UMRS 1018</s1>
<s2>Villejuif</s2>
<s3>FRA</s3>
<sZ>16 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Saussier, Cristel" sort="Saussier, Cristel" uniqKey="Saussier C" first="Cristel" last="Saussier">Cristel Saussier</name>
<affiliation><inist:fA14 i1="15"><s1>Agence Nationale de Sécurité des Medicaments et des Produits de Santé</s1>
<s2>Saint-Denis</s2>
<s3>FRA</s3>
<sZ>17 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Pariente, Antoine" sort="Pariente, Antoine" uniqKey="Pariente A" first="Antoine" last="Pariente">Antoine Pariente</name>
<affiliation><inist:fA14 i1="10"><s1>Inserm, CIC-P 0005, Pharmacoepidemiology Department, CHU de Bordeaux</s1>
<s3>FRA</s3>
<sZ>9 aut.</sZ>
<sZ>18 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Brain</title>
<title level="j" type="abbreviated">Brain</title>
<idno type="ISSN">0006-8950</idno>
<imprint><date when="2013">2013</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">Brain</title>
<title level="j" type="abbreviated">Brain</title>
<idno type="ISSN">0006-8950</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Cataplexy</term>
<term>Child</term>
<term>France</term>
<term>H1N1 influenza</term>
<term>Infection</term>
<term>Narcolepsy</term>
<term>Nervous system diseases</term>
<term>Prevention</term>
<term>Risk factor</term>
<term>Vaccination</term>
<term>Vaccine</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Narcolepsie</term>
<term>Infection</term>
<term>Pathologie du système nerveux</term>
<term>Facteur risque</term>
<term>Enfant</term>
<term>Vaccination</term>
<term>France</term>
<term>Cataplexie</term>
<term>Prévention</term>
<term>Vaccin</term>
<term>Grippe H1N1</term>
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<front><div type="abstract" xml:lang="en">An increased incidence of narcolepsy in children was detected in Scandinavian countries where pandemic H1N1 influenza ASO3-adjuvanted vaccine was used. A campaign of vaccination against pandemic H1N1 influenza was implemented in France using both AS03-adjuvanted and non-adjuvanted vaccines. As part of a study considering all-type narcolepsy, we investigated the association between H1N1 vaccination and narcolepsy with cataplexy in children and adults compared with matched controls; and compared the phenotype of narcolepsy with cataplexy according to exposure to the H1N1 vaccination. Patients with narcolepsy-cataplexy were included from 14 expert centres in France. Date of diagnosis constituted the index date. Validation of cases was performed by independent experts using the Brighton collaboration criteria. Up to four controls were individually matched to cases according to age, gender and geographic location. A structured telephone interview was performed to collect information on medical history, past infections and vaccinations. Eighty-five cases with narcolepsy-cataplexy were included; 23 being further excluded regarding eligibility criteria. Of the 62 eligible cases, 59 (64% males, 57.6% children) could be matched with 135 control subjects. H1N1 vaccination was associated with narcolepsy-cataplexy with an odds ratio of 6.5 (2.1-19.9) in subjects aged <18 years, and 4.7 (1.6-13.9) in those aged 18 and over. Sensitivity analyses considering date of referral for diagnosis or the date of onset of symptoms as the index date gave similar results, as did analyses focusing only on exposure to AS03-adjuvanted vaccine. Slight differences were found when comparing cases with narcolepsy-cataplexy exposed to H1N1 vaccination (n = 32; mostly AS03-adjuvanted vaccine, n = 28) to non-exposed cases (n = 30), including shorter delay of diagnosis and a higher number of sleep onset rapid eye movement periods for exposed cases. No difference was found regarding history of infections. In this sub-analysis, H1N1 vaccination was strongly associated with an increased risk of narcolepsy-cataplexy in both children and adults in France. Even if, as in every observational study, the possibility that some biases participated in the association cannot be completely ruled out, the associations appeared robust to sensitivity analyses, and a specific analysis focusing on AS03-adjuvanted vaccine found similar increase.</div>
</front>
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<fA08 i1="01" i2="1" l="ENG"><s1>Increased risk of narcolepsy in children and adults after pandemic H1N1 vaccination in France</s1>
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<fA11 i1="14" i2="1"><s1>SCHOLZ (Sabine)</s1>
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<fA11 i1="15" i2="1"><s1>LAVAULT (Sophie)</s1>
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<fA11 i1="16" i2="1"><s1>TUBERT-BITTER (Pascale)</s1>
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<fA11 i1="17" i2="1"><s1>SAUSSIER (Cristel)</s1>
</fA11>
<fA11 i1="18" i2="1"><s1>PARIENTE (Antoine)</s1>
</fA11>
<fA14 i1="01"><s1>Sleep Disorder Centre, Neurology Department, Gui de Chauliac hospital, CHU Montpellier, INSERM, U1061</s1>
<s2>Montpellier</s2>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>National Reference Network for Orphan Diseases (Narcolepsy, Idiopathic Hypersomnia and Kleine Levin syndrome)</s1>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>Sleep Disorder Unit, Hospital la Pitié-Salpêtrière, AP-HP</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>2 aut.</sZ>
<sZ>15 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>Paediatric Sleep Disorder Centre, CHU Robert-Debré, AP-HP</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>Sleep Unit, Clinical Neurophysiology Department, Université Lille Nord de France; Lille University Hospital</s1>
<s2>Lille</s2>
<s3>FRA</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>INSERM, U1028, Lyon, France; Paediatric Sleep Unit, Hôpital Femme-Mère-Enfant</s1>
<s2>Lyon</s2>
<s3>FRA</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>Sleep Centre Physiology Department, Functional Explorations, Hôpital Henri Mondor</s1>
<s2>Creteil</s2>
<s3>FRA</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="08"><s1>Sleep Centre - Neurophysiology, Department of Physiology, Functional Explorations, Bichat Hospital, AP-HP, Université Denis Diderot Paris 7Paris</s1>
<s3>FRA</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="09"><s1>Sleep Laboratory and Physiology Department, Grenoble University Hospital, Inserm, U1042</s1>
<s2>Grenoble</s2>
<s3>FRA</s3>
<sZ>8 aut.</sZ>
</fA14>
<fA14 i1="10"><s1>Inserm, CIC-P 0005, Pharmacoepidemiology Department, CHU de Bordeaux</s1>
<s3>FRA</s3>
<sZ>9 aut.</sZ>
<sZ>18 aut.</sZ>
</fA14>
<fA14 i1="11"><s1>Sleep Disorder Centre, CHU Strasbourg, CNRS UPR 3212</s1>
<s2>Strasbourg</s2>
<s3>FRA</s3>
<sZ>10 aut.</sZ>
</fA14>
<fA14 i1="12"><s1>Functional Explorations Laboratory, Rare Hypersomnia Competence Centre, Hôpital Laennec</s1>
<s2>Nantes</s2>
<s3>FRA</s3>
<sZ>11 aut.</sZ>
</fA14>
<fA14 i1="13"><s1>Clinical Neurophysiology Unit, La Timone Hospital</s1>
<s2>Marseille</s2>
<s3>FRA</s3>
<sZ>12 aut.</sZ>
</fA14>
<fA14 i1="14"><s1>INSERM, U1018, Centre for Research in Epidemiology and Population Health (CESP), Biostatistics Team, Villejuif, France. Univ Paris Sud, UMRS 1018</s1>
<s2>Villejuif</s2>
<s3>FRA</s3>
<sZ>16 aut.</sZ>
</fA14>
<fA14 i1="15"><s1>Agence Nationale de Sécurité des Medicaments et des Produits de Santé</s1>
<s2>Saint-Denis</s2>
<s3>FRA</s3>
<sZ>17 aut.</sZ>
</fA14>
<fA17 i1="01" i2="1"><s1>Narcoflu-VF study group</s1>
<s3>INC</s3>
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<fC01 i1="01" l="ENG"><s0>An increased incidence of narcolepsy in children was detected in Scandinavian countries where pandemic H1N1 influenza ASO3-adjuvanted vaccine was used. A campaign of vaccination against pandemic H1N1 influenza was implemented in France using both AS03-adjuvanted and non-adjuvanted vaccines. As part of a study considering all-type narcolepsy, we investigated the association between H1N1 vaccination and narcolepsy with cataplexy in children and adults compared with matched controls; and compared the phenotype of narcolepsy with cataplexy according to exposure to the H1N1 vaccination. Patients with narcolepsy-cataplexy were included from 14 expert centres in France. Date of diagnosis constituted the index date. Validation of cases was performed by independent experts using the Brighton collaboration criteria. Up to four controls were individually matched to cases according to age, gender and geographic location. A structured telephone interview was performed to collect information on medical history, past infections and vaccinations. Eighty-five cases with narcolepsy-cataplexy were included; 23 being further excluded regarding eligibility criteria. Of the 62 eligible cases, 59 (64% males, 57.6% children) could be matched with 135 control subjects. H1N1 vaccination was associated with narcolepsy-cataplexy with an odds ratio of 6.5 (2.1-19.9) in subjects aged <18 years, and 4.7 (1.6-13.9) in those aged 18 and over. Sensitivity analyses considering date of referral for diagnosis or the date of onset of symptoms as the index date gave similar results, as did analyses focusing only on exposure to AS03-adjuvanted vaccine. Slight differences were found when comparing cases with narcolepsy-cataplexy exposed to H1N1 vaccination (n = 32; mostly AS03-adjuvanted vaccine, n = 28) to non-exposed cases (n = 30), including shorter delay of diagnosis and a higher number of sleep onset rapid eye movement periods for exposed cases. No difference was found regarding history of infections. In this sub-analysis, H1N1 vaccination was strongly associated with an increased risk of narcolepsy-cataplexy in both children and adults in France. Even if, as in every observational study, the possibility that some biases participated in the association cannot be completely ruled out, the associations appeared robust to sensitivity analyses, and a specific analysis focusing on AS03-adjuvanted vaccine found similar increase.</s0>
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<fC03 i1="06" i2="X" l="ENG"><s0>Vaccination</s0>
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<s5>14</s5>
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<s5>15</s5>
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<s5>15</s5>
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<s5>15</s5>
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<s5>96</s5>
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<s4>CD</s4>
<s5>96</s5>
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<s4>CD</s4>
<s5>96</s5>
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<s2>NG</s2>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Europa</s0>
<s2>NG</s2>
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<s5>38</s5>
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<s5>38</s5>
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<s5>38</s5>
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<fC07 i1="04" i2="X" l="FRE"><s0>Trouble du sommeil</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Sleep disorder</s0>
<s5>39</s5>
</fC07>
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<s5>39</s5>
</fC07>
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<s5>40</s5>
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<s5>40</s5>
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<s5>40</s5>
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<s5>41</s5>
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<s5>41</s5>
</fC07>
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<s5>41</s5>
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<server><NO>PASCAL 13-0247443 INIST</NO>
<ET>Increased risk of narcolepsy in children and adults after pandemic H1N1 vaccination in France</ET>
<AU>DAUVILLIERS (Yves); ARNULF (Isabelle); LECENDREUX (Michel); MONACA CHARLEY (Christelle); FRANCO (Patricia); DROUOT (Xavier); D'ORTHO (Marie-Pia); LAUNOIS (Sandrine); LIGNOT (Séverine); BOURGIN (Patrice); NOGUES (Béatrice); REY (Marc); BAYARD (Sophie); SCHOLZ (Sabine); LAVAULT (Sophie); TUBERT-BITTER (Pascale); SAUSSIER (Cristel); PARIENTE (Antoine)</AU>
<AF>Sleep Disorder Centre, Neurology Department, Gui de Chauliac hospital, CHU Montpellier, INSERM, U1061/Montpellier/France (1 aut., 13 aut., 14 aut.); National Reference Network for Orphan Diseases (Narcolepsy, Idiopathic Hypersomnia and Kleine Levin syndrome)/France (1 aut., 2 aut., 3 aut., 5 aut., 13 aut., 14 aut., 15 aut.); Sleep Disorder Unit, Hospital la Pitié-Salpêtrière, AP-HP/Paris/France (2 aut., 15 aut.); Paediatric Sleep Disorder Centre, CHU Robert-Debré, AP-HP/Paris/France (3 aut.); Sleep Unit, Clinical Neurophysiology Department, Université Lille Nord de France; Lille University Hospital/Lille/France (4 aut.); INSERM, U1028, Lyon, France; Paediatric Sleep Unit, Hôpital Femme-Mère-Enfant/Lyon/France (5 aut.); Sleep Centre Physiology Department, Functional Explorations, Hôpital Henri Mondor/Creteil/France (6 aut.); Sleep Centre - Neurophysiology, Department of Physiology, Functional Explorations, Bichat Hospital, AP-HP, Université Denis Diderot Paris 7Paris/France (7 aut.); Sleep Laboratory and Physiology Department, Grenoble University Hospital, Inserm, U1042/Grenoble/France (8 aut.); Inserm, CIC-P 0005, Pharmacoepidemiology Department, CHU de Bordeaux/France (9 aut., 18 aut.); Sleep Disorder Centre, CHU Strasbourg, CNRS UPR 3212/Strasbourg/France (10 aut.); Functional Explorations Laboratory, Rare Hypersomnia Competence Centre, Hôpital Laennec/Nantes/France (11 aut.); Clinical Neurophysiology Unit, La Timone Hospital/Marseille/France (12 aut.); INSERM, U1018, Centre for Research in Epidemiology and Population Health (CESP), Biostatistics Team, Villejuif, France. Univ Paris Sud, UMRS 1018/Villejuif/France (16 aut.); Agence Nationale de Sécurité des Medicaments et des Produits de Santé/Saint-Denis/France (17 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Brain; ISSN 0006-8950; Royaume-Uni; Da. 2013; Vol. 136; No. p. 8; Pp. 2486-2496; Bibl. 3/4 p.</SO>
<LA>Anglais</LA>
<EA>An increased incidence of narcolepsy in children was detected in Scandinavian countries where pandemic H1N1 influenza ASO3-adjuvanted vaccine was used. A campaign of vaccination against pandemic H1N1 influenza was implemented in France using both AS03-adjuvanted and non-adjuvanted vaccines. As part of a study considering all-type narcolepsy, we investigated the association between H1N1 vaccination and narcolepsy with cataplexy in children and adults compared with matched controls; and compared the phenotype of narcolepsy with cataplexy according to exposure to the H1N1 vaccination. Patients with narcolepsy-cataplexy were included from 14 expert centres in France. Date of diagnosis constituted the index date. Validation of cases was performed by independent experts using the Brighton collaboration criteria. Up to four controls were individually matched to cases according to age, gender and geographic location. A structured telephone interview was performed to collect information on medical history, past infections and vaccinations. Eighty-five cases with narcolepsy-cataplexy were included; 23 being further excluded regarding eligibility criteria. Of the 62 eligible cases, 59 (64% males, 57.6% children) could be matched with 135 control subjects. H1N1 vaccination was associated with narcolepsy-cataplexy with an odds ratio of 6.5 (2.1-19.9) in subjects aged <18 years, and 4.7 (1.6-13.9) in those aged 18 and over. Sensitivity analyses considering date of referral for diagnosis or the date of onset of symptoms as the index date gave similar results, as did analyses focusing only on exposure to AS03-adjuvanted vaccine. Slight differences were found when comparing cases with narcolepsy-cataplexy exposed to H1N1 vaccination (n = 32; mostly AS03-adjuvanted vaccine, n = 28) to non-exposed cases (n = 30), including shorter delay of diagnosis and a higher number of sleep onset rapid eye movement periods for exposed cases. No difference was found regarding history of infections. In this sub-analysis, H1N1 vaccination was strongly associated with an increased risk of narcolepsy-cataplexy in both children and adults in France. Even if, as in every observational study, the possibility that some biases participated in the association cannot be completely ruled out, the associations appeared robust to sensitivity analyses, and a specific analysis focusing on AS03-adjuvanted vaccine found similar increase.</EA>
<CC>002B17; 002B17G</CC>
<FD>Narcolepsie; Infection; Pathologie du système nerveux; Facteur risque; Enfant; Vaccination; France; Cataplexie; Prévention; Vaccin; Grippe H1N1</FD>
<FG>Homme; Europe; Trouble neurologique; Trouble du sommeil; Pathologie de l'appareil respiratoire; Virose</FG>
<ED>Narcolepsy; Infection; Nervous system diseases; Risk factor; Child; Vaccination; France; Cataplexy; Prevention; Vaccine; H1N1 influenza</ED>
<EG>Human; Europe; Neurological disorder; Sleep disorder; Respiratory disease; Viral disease</EG>
<SD>Narcolepsia; Infección; Sistema nervioso patología; Factor riesgo; Niño; Vacunación; Francia; Cataplexia; Prevención; Vacuna; Gripe H1N1</SD>
<LO>INIST-998.354000506516950140</LO>
<ID>13-0247443</ID>
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