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 : 000B54 ( Main/Exploration ); précédent : 000B53; suivant : 000B55Maternal 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.
Url:
DOI: 10.1059/0003-4819-155-11-201112060-00005
Affiliations:
- France
- Franche-Comté, Région Bretagne
- Besançon, Rennes
- Université de Bourgogne Franche-Comté, Université de Franche-Comté, Université de Rennes 1, Université européenne de Bretagne
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Le document en format XML
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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><affiliations><list><country><li>France</li></country><region><li>Franche-Comté</li><li>Région Bretagne</li></region><settlement><li>Besançon</li><li>Rennes</li></settlement><orgName><li>Université de Bourgogne Franche-Comté</li><li>Université de Franche-Comté</li><li>Université de Rennes 1</li><li>Université européenne de Bretagne</li></orgName></list><tree><noCountry><name sortKey="Bulifon, Sophie" sort="Bulifon, Sophie" uniqKey="Bulifon S" first="Sophie" last="Bulifon">Sophie Bulifon</name><name sortKey="Capitant, Catherine" sort="Capitant, Catherine" uniqKey="Capitant C" first="Catherine" last="Capitant">Catherine Capitant</name><name sortKey="Jacqz Aigrain, Evelyne" sort="Jacqz Aigrain, Evelyne" uniqKey="Jacqz Aigrain E" first="Evelyne" last="Jacqz-Aigrain">Evelyne Jacqz-Aigrain</name><name sortKey="Lewin, Fanny" sort="Lewin, Fanny" uniqKey="Lewin F" first="Fanny" last="Lewin">Fanny Lewin</name></noCountry><country name="France"><noRegion><name sortKey="Tsatsaris, Vassilis" sort="Tsatsaris, Vassilis" uniqKey="Tsatsaris V" first="Vassilis" last="Tsatsaris">Vassilis Tsatsaris</name></noRegion><name sortKey="Aboulker, Jean Pierre" sort="Aboulker, Jean Pierre" uniqKey="Aboulker J" first="Jean-Pierre" last="Aboulker">Jean-Pierre Aboulker</name><name sortKey="Chazallon, Corine" sort="Chazallon, Corine" uniqKey="Chazallon C" first="Corine" last="Chazallon">Corine Chazallon</name><name sortKey="Laine, Fabrice" sort="Laine, Fabrice" uniqKey="Laine F" first="Fabrice" last="Lainé">Fabrice Lainé</name><name sortKey="Launay, Odile" sort="Launay, Odile" uniqKey="Launay O" first="Odile" last="Launay">Odile Launay</name><name sortKey="Picone, Olivier" sort="Picone, Olivier" uniqKey="Picone O" first="Olivier" last="Picone">Olivier Picone</name><name sortKey="Poulain, Patrice" sort="Poulain, Patrice" uniqKey="Poulain P" first="Patrice" last="Poulain">Patrice Poulain</name><name sortKey="Riethmuller, Didier" sort="Riethmuller, Didier" uniqKey="Riethmuller D" first="Didier" last="Riethmuller">Didier Riethmuller</name><name sortKey="Schmitz, Thomas" sort="Schmitz, Thomas" uniqKey="Schmitz T" first="Thomas" last="Schmitz">Thomas Schmitz</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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