Maternal immune response and neonatal seroprotection from a single dose of a monovalent nonadjuvanted 2009 influenza A(H1N1) vaccine: a single-group trial.
Identifieur interne : 000209 ( Hal/Checkpoint ); précédent : 000208; suivant : 000210Maternal immune response and neonatal seroprotection from a single dose of a monovalent nonadjuvanted 2009 influenza A(H1N1) vaccine: a single-group trial.
Auteurs : Vassilis Tsatsaris [France] ; Catherine Capitant ; Thomas Schmitz [France] ; Corine Chazallon [France] ; Sophie Bulifon ; Didier Riethmuller [France] ; Olivier Picone [France] ; Patrice Poulain [France] ; Fanny Lewin ; Fabrice Lainé [France] ; Evelyne Jacqz-Aigrain ; Jean-Pierre Aboulker [France] ; Odile Launay [France]Source :
- Annals of Internal Medicine [ 0003-4819 ] ; 2011-12-06.
Abstract
BACKGROUND: Pregnant women and infants who get influenza are at increased risk for severe illness. OBJECTIVE: To evaluate the immunogenicity and transplacental antibody transfer of 2009 pandemic influenza A(H1N1) vaccine administered during pregnancy. DESIGN: Prospective, multicenter, single-group clinical trial. (ClinicalTrials.gov registration number: NCT01024400) SETTING: Five level-3 perinatal centers in France. PATIENTS: 107 pregnant women between 22(0/7) and 32(0/7) weeks of gestation. INTERVENTION: An intramuscular dose of a nonadjuvanted H1N1 vaccine that contained 15 mcg of hemagglutinin. MEASUREMENTS: Proportion of women with an influenza antibody titer of 1:40 or greater at days 21 and 42 after vaccination, delivery, and 3 months after delivery. Seroconversion rate, fold increase in the geometric mean titer 21 days after vaccination, and proportion of neonates with an antibody titer of 1:40 or greater at birth were also assessed. RESULTS: At baseline, 19% of the women had an antibody titer of 1:40 or greater. At day 21, 98% of the women had an antibody titer of 1:40 or greater, the seroconversion rate was 93%, and the fold increase in geometric mean titer was 67.4. At day 42, delivery, and 3 months after delivery, 98%, 92%, and 90% of the women, respectively, had an antibody titer of 1:40 or greater. Ninety-five percent of the cord serum samples obtained from 88 neonates showed an antibody titer of 1:40 or greater. The median neonate-mother antibody titer ratio was 1.4. LIMITATIONS: Only healthy pregnant women were selected. Data on hemagglutination inhibition antibody titers of infants were reported only at birth. CONCLUSION: A single dose of a nonadjuvanted influenza A(H1N1) vaccine with 15 mcg of hemagglutinin triggered a strong immune response in pregnant women and a high rate of neonatal seroprotection. PRIMARY FUNDING SOURCE: French National Institute of Health and Medical Research.
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DOI: 10.1059/0003-4819-155-11-201112060-00005
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Santé - Innovation Technologique </orgName> <desc> <address> <addrLine>Université Rennes 1 - Campus Santé Villejean - 2, avenue Professeur Léon Bernard 35043 Rennes cedex</addrLine> <country key="FR"></country> </address> </desc> </org></tutelle></tutelles></hal:affiliation><country>France</country><placeName><settlement type="city">Rennes</settlement><region type="region" nuts="2">Région Bretagne</region></placeName><orgName type="university">Université de Rennes 1</orgName><orgName type="institution" wicri:auto="newGroup">Université européenne de Bretagne</orgName></affiliation></author><author><name sortKey="Jacqz Aigrain, Evelyne" sort="Jacqz Aigrain, Evelyne" uniqKey="Jacqz Aigrain E" first="Evelyne" last="Jacqz-Aigrain">Evelyne Jacqz-Aigrain</name></author><author><name sortKey="Aboulker, Jean Pierre" sort="Aboulker, Jean Pierre" uniqKey="Aboulker J" first="Jean-Pierre" last="Aboulker">Jean-Pierre Aboulker</name><affiliation wicri:level="1"><hal:affiliation type="laboratory" xml:id="struct-2794" status="OLD"> <orgName>Essais Therapeutiques et Infection Par Le Vih</orgName> <date type="end">2012</date> <desc> <address> <addrLine>Centre de Recherche Inserm PARIS XI 16, Avenue Paul Vaillant-Couturier 94807 VILLEJUIF CEDEX</addrLine> <country key="FR"></country> </address> </desc> <listRelation> <relation active="#struct-92966" type="direct"></relation> <relation name="SC10" active="#struct-303623" type="direct"></relation> </listRelation> <tutelles><tutelle active="#struct-92966" type="direct"><org type="institution" xml:id="struct-92966" status="VALID"> <orgName>Université Paris-Sud - Paris 11</orgName> <orgName type="acronym">UP11</orgName> <desc> <address> <addrLine>Bâtiment 300 - 91405 Orsay cedex</addrLine> <country key="FR"></country> </address> <ref type="url">http://www.u-psud.fr/</ref> </desc> </org></tutelle><tutelle name="SC10" active="#struct-303623" type="direct"><org type="institution" xml:id="struct-303623" status="VALID"> <idno type="IdRef">026388278</idno> <orgName>Institut National de la Santé et de la Recherche Médicale</orgName> <orgName type="acronym">INSERM</orgName> <desc> <address> <addrLine>101, rue de Tolbiac, 75013 Paris </addrLine> <country key="FR"></country> </address> <ref type="url">http://www.inserm.fr</ref> </desc> </org></tutelle></tutelles></hal:affiliation><country>France</country></affiliation></author><author><name sortKey="Launay, Odile" sort="Launay, Odile" uniqKey="Launay O" first="Odile" last="Launay">Odile Launay</name><affiliation wicri:level="1"><hal:affiliation type="laboratory" xml:id="struct-2593" status="OLD"> <orgName>CIC - Biotherapie - AP-HP (cochin - Pasteur)</orgName> <desc> <address> <addrLine>Hopital Cochin PARIS V 27, Rue du Faubourg Saint-Jacques 75679 PARIS CEDEX 14</addrLine> <country key="FR"></country> </address> </desc> <listRelation> <relation name="CBT505" active="#struct-303623" type="direct"></relation> </listRelation> <tutelles><tutelle name="CBT505" active="#struct-303623" type="direct"><org type="institution" xml:id="struct-303623" status="VALID"> <idno type="IdRef">026388278</idno> <orgName>Institut National de la Santé et de la Recherche Médicale</orgName> <orgName type="acronym">INSERM</orgName> <desc> <address> <addrLine>101, rue de Tolbiac, 75013 Paris </addrLine> <country key="FR"></country> </address> <ref type="url">http://www.inserm.fr</ref> </desc> </org></tutelle></tutelles></hal:affiliation><country>France</country></affiliation></author></analytic><idno type="DOI">10.1059/0003-4819-155-11-201112060-00005</idno><series><title level="j">Annals of Internal Medicine</title><idno type="ISSN">0003-4819</idno><imprint><date type="datePub">2011-12-06</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"> <p>BACKGROUND: Pregnant women and infants who get influenza are at increased risk for severe illness. OBJECTIVE: To evaluate the immunogenicity and transplacental antibody transfer of 2009 pandemic influenza A(H1N1) vaccine administered during pregnancy. DESIGN: Prospective, multicenter, single-group clinical trial. (ClinicalTrials.gov registration number: NCT01024400) SETTING: Five level-3 perinatal centers in France. PATIENTS: 107 pregnant women between 22(0/7) and 32(0/7) weeks of gestation. INTERVENTION: An intramuscular dose of a nonadjuvanted H1N1 vaccine that contained 15 mcg of hemagglutinin. MEASUREMENTS: Proportion of women with an influenza antibody titer of 1:40 or greater at days 21 and 42 after vaccination, delivery, and 3 months after delivery. Seroconversion rate, fold increase in the geometric mean titer 21 days after vaccination, and proportion of neonates with an antibody titer of 1:40 or greater at birth were also assessed. RESULTS: At baseline, 19% of the women had an antibody titer of 1:40 or greater. At day 21, 98% of the women had an antibody titer of 1:40 or greater, the seroconversion rate was 93%, and the fold increase in geometric mean titer was 67.4. At day 42, delivery, and 3 months after delivery, 98%, 92%, and 90% of the women, respectively, had an antibody titer of 1:40 or greater. Ninety-five percent of the cord serum samples obtained from 88 neonates showed an antibody titer of 1:40 or greater. The median neonate-mother antibody titer ratio was 1.4. LIMITATIONS: Only healthy pregnant women were selected. Data on hemagglutination inhibition antibody titers of infants were reported only at birth. CONCLUSION: A single dose of a nonadjuvanted influenza A(H1N1) vaccine with 15 mcg of hemagglutinin triggered a strong immune response in pregnant women and a high rate of neonatal seroprotection. PRIMARY FUNDING SOURCE: French National Institute of Health and Medical Research.</p> </div></front></TEI><hal api="V3"> <titleStmt> <title xml:lang="it">Maternal immune response and neonatal seroprotection from a single dose of a monovalent nonadjuvanted 2009 influenza A(H1N1) vaccine: a single-group trial.</title> <author role="aut"> <persName> <forename type="first">Vassilis</forename> <surname>Tsatsaris</surname> </persName> <idno type="halauthorid">89022</idno> <affiliation ref="#struct-2840"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Catherine</forename> <surname>Capitant</surname> </persName> <idno type="halauthorid">775252</idno> </author> <author role="aut"> <persName> <forename type="first">Thomas</forename> <surname>Schmitz</surname> </persName> <idno type="halauthorid">144027</idno> <affiliation ref="#struct-28699"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Corine</forename> <surname>Chazallon</surname> </persName> <idno type="halauthorid">478219</idno> <affiliation ref="#struct-2794"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Sophie</forename> <surname>Bulifon</surname> </persName> <idno type="halauthorid">775253</idno> </author> <author role="aut"> <persName> <forename type="first">Didier</forename> <surname>Riethmuller</surname> </persName> <idno type="halauthorid">464395</idno> <affiliation ref="#struct-111518"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Olivier</forename> <surname>Picone</surname> </persName> <idno type="halauthorid">523991</idno> <affiliation ref="#struct-2183"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Patrice</forename> <surname>Poulain</surname> </persName> <idno type="halauthorid">554814</idno> <affiliation ref="#struct-199631"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Fanny</forename> <surname>Lewin</surname> </persName> <idno type="halauthorid">775254</idno> </author> <author role="aut"> <persName> <forename type="first">Fabrice</forename> <surname>Lainé</surname> </persName> <idno type="halauthorid">770223</idno> <affiliation ref="#struct-399803"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Evelyne</forename> <surname>Jacqz-Aigrain</surname> </persName> <idno type="halauthorid">775255</idno> </author> <author role="aut"> <persName> <forename type="first">Jean-Pierre</forename> <surname>Aboulker</surname> </persName> <idno type="halauthorid">707359</idno> <affiliation ref="#struct-2794"></affiliation> </author> <author role="crp"> <persName> <forename type="first">Odile</forename> <surname>Launay</surname> </persName> <email type="md5">3a9306133151a9800c3d9ad5e5f025d0</email> <email type="domain">cch.aphp.fr</email> <idno type="halauthorid">632155</idno> <affiliation ref="#struct-2593"></affiliation> </author> <editor role="depositor"> <persName> <forename>Alice</forename> <surname>Brébion</surname> </persName> <email type="md5">101fc188aa6e25cced9d6c1509a47d2f</email> <email type="domain">univ-rennes1.fr</email> </editor> </titleStmt> <editionStmt> <edition n="v1" type="current"> <date type="whenSubmitted">2012-10-23 14:10:57</date> <date type="whenModified">2020-03-27 02:25:24</date> <date type="whenReleased">2012-10-23 14:10:57</date> <date type="whenProduced">2011-12-06</date> </edition> <respStmt> <resp>contributor</resp> <name key="167812"> <persName> <forename>Alice</forename> <surname>Brébion</surname> </persName> <email type="md5">101fc188aa6e25cced9d6c1509a47d2f</email> <email type="domain">univ-rennes1.fr</email> </name> </respStmt> </editionStmt> <publicationStmt> <distributor>CCSD</distributor> <idno type="halId">hal-00744538</idno> <idno type="halUri">https://hal.archives-ouvertes.fr/hal-00744538</idno> <idno type="halBibtex">tsatsaris:hal-00744538</idno> <idno type="halRefHtml">Annals of Internal Medicine, 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<title xml:lang="it">Maternal immune response and neonatal seroprotection from a single dose of a monovalent nonadjuvanted 2009 influenza A(H1N1) vaccine: a single-group trial.</title> <author role="aut"> <persName> <forename type="first">Vassilis</forename> <surname>Tsatsaris</surname> </persName> <idno type="halauthorid">89022</idno> <affiliation ref="#struct-2840"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Catherine</forename> <surname>Capitant</surname> </persName> <idno type="halauthorid">775252</idno> </author> <author role="aut"> <persName> <forename type="first">Thomas</forename> <surname>Schmitz</surname> </persName> <idno type="halauthorid">144027</idno> <affiliation ref="#struct-28699"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Corine</forename> <surname>Chazallon</surname> </persName> <idno type="halauthorid">478219</idno> <affiliation ref="#struct-2794"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Sophie</forename> <surname>Bulifon</surname> </persName> <idno type="halauthorid">775253</idno> </author> <author role="aut"> <persName> <forename type="first">Didier</forename> <surname>Riethmuller</surname> </persName> <idno type="halauthorid">464395</idno> <affiliation ref="#struct-111518"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Olivier</forename> <surname>Picone</surname> </persName> <idno type="halauthorid">523991</idno> <affiliation ref="#struct-2183"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Patrice</forename> <surname>Poulain</surname> </persName> <idno type="halauthorid">554814</idno> <affiliation ref="#struct-199631"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Fanny</forename> <surname>Lewin</surname> </persName> <idno type="halauthorid">775254</idno> </author> <author role="aut"> <persName> <forename type="first">Fabrice</forename> <surname>Lainé</surname> </persName> <idno type="halauthorid">770223</idno> <affiliation ref="#struct-399803"></affiliation> </author> <author role="aut"> <persName> <forename type="first">Evelyne</forename> <surname>Jacqz-Aigrain</surname> </persName> <idno type="halauthorid">775255</idno> </author> <author role="aut"> <persName> <forename type="first">Jean-Pierre</forename> <surname>Aboulker</surname> </persName> <idno type="halauthorid">707359</idno> <affiliation ref="#struct-2794"></affiliation> </author> <author role="crp"> <persName> <forename type="first">Odile</forename> <surname>Launay</surname> </persName> <email type="md5">3a9306133151a9800c3d9ad5e5f025d0</email> <email type="domain">cch.aphp.fr</email> <idno type="halauthorid">632155</idno> <affiliation ref="#struct-2593"></affiliation> </author> </analytic> <monogr> <idno type="halJournalId" status="VALID">22712</idno> <idno type="issn">0003-4819</idno> <idno type="eissn">1539-3704</idno> <title level="j">Annals of Internal Medicine</title> <imprint> <publisher>American College of Physicians</publisher> <biblScope unit="volume">155</biblScope> <biblScope unit="issue">11</biblScope> <biblScope unit="pp">733-41</biblScope> <date type="datePub">2011-12-06</date> </imprint> </monogr> <idno type="doi">10.1059/0003-4819-155-11-201112060-00005</idno> <idno type="pubmed">22147712</idno> </biblStruct> </sourceDesc> <profileDesc> <langUsage> <language ident="en">English</language> </langUsage> <textClass> <classCode scheme="mesh">Adolescent</classCode> <classCode scheme="mesh">Adult</classCode> <classCode scheme="mesh">Influenza, Human</classCode> <classCode scheme="mesh">Maternal-Fetal Exchange</classCode> <classCode scheme="mesh">Middle Aged</classCode> <classCode scheme="mesh">Neutralization Tests</classCode> <classCode scheme="mesh">Pregnancy</classCode> <classCode scheme="mesh">Pregnancy Complications, Infectious</classCode> <classCode scheme="mesh">Pregnancy Trimester, Second</classCode> <classCode scheme="mesh">Pregnancy Trimester, Third</classCode> <classCode scheme="mesh">Prospective Studies</classCode> <classCode scheme="mesh">Young Adult</classCode> <classCode scheme="mesh">Antibodies, Viral</classCode> <classCode scheme="mesh">Female</classCode> <classCode scheme="mesh">Fetal Blood</classCode> <classCode scheme="mesh">Hemagglutination Inhibition Tests</classCode> <classCode scheme="mesh">Humans</classCode> <classCode scheme="mesh">Infant, Newborn</classCode> <classCode scheme="mesh">Influenza A Virus, H1N1 Subtype</classCode> <classCode scheme="mesh">Influenza Vaccines</classCode> <classCode scheme="halDomain" n="sdv.mhep">Life Sciences [q-bio]/Human health and pathology</classCode> <classCode scheme="halTypology" n="ART">Journal articles</classCode> </textClass> <abstract xml:lang="en"> <p>BACKGROUND: Pregnant women and infants who get influenza are at increased risk for severe illness. OBJECTIVE: To evaluate the immunogenicity and transplacental antibody transfer of 2009 pandemic influenza A(H1N1) vaccine administered during pregnancy. DESIGN: Prospective, multicenter, single-group clinical trial. (ClinicalTrials.gov registration number: NCT01024400) SETTING: Five level-3 perinatal centers in France. PATIENTS: 107 pregnant women between 22(0/7) and 32(0/7) weeks of gestation. INTERVENTION: An intramuscular dose of a nonadjuvanted H1N1 vaccine that contained 15 mcg of hemagglutinin. MEASUREMENTS: Proportion of women with an influenza antibody titer of 1:40 or greater at days 21 and 42 after vaccination, delivery, and 3 months after delivery. Seroconversion rate, fold increase in the geometric mean titer 21 days after vaccination, and proportion of neonates with an antibody titer of 1:40 or greater at birth were also assessed. RESULTS: At baseline, 19% of the women had an antibody titer of 1:40 or greater. At day 21, 98% of the women had an antibody titer of 1:40 or greater, the seroconversion rate was 93%, and the fold increase in geometric mean titer was 67.4. At day 42, delivery, and 3 months after delivery, 98%, 92%, and 90% of the women, respectively, had an antibody titer of 1:40 or greater. Ninety-five percent of the cord serum samples obtained from 88 neonates showed an antibody titer of 1:40 or greater. The median neonate-mother antibody titer ratio was 1.4. LIMITATIONS: Only healthy pregnant women were selected. Data on hemagglutination inhibition antibody titers of infants were reported only at birth. CONCLUSION: A single dose of a nonadjuvanted influenza A(H1N1) vaccine with 15 mcg of hemagglutinin triggered a strong immune response in pregnant women and a high rate of neonatal seroprotection. PRIMARY FUNDING SOURCE: French National Institute of Health and Medical Research.</p> </abstract> <particDesc> <org type="consortium">Inserm C09-33 PREFLUVAC (Immunogenicity and Safety of an Inactivated Nonadjuvanted A[H1N1v] Influenza Vaccine in Pregnant Women) Study Group.</org> </particDesc> </profileDesc> </hal></record>Pour manipuler ce document sous Unix (Dilib)
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