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 : 000730 ( France/Analysis ); précédent : 000729; suivant : 000731Maternal 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 ; Corine Chazallon ; Sophie Bulifon ; Didier Riethmuller ; Olivier Picone ; Patrice Poulain ; Fanny Lewin ; Fabrice Laine ; Evelyne Jacqz-Aigrain ; Jean-Pierre Aboulker ; Odile LaunaySource :
- Annals of internal medicine [ 0003-4819 ] ; 2011.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Santé publique, Vaccin, Médecine.
English descriptors
- KwdEn :
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. (Clinical Trials.gov registration number: NCT01024400) Setting: Five level-3 perinatal centers in France. Patients: 107 pregnant women between 220/7 and 320/7 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:
Affiliations:
- France
- Bourgogne-Franche-Comté, Franche-Comté, Région Bretagne, Île-de-France
- Besançon, Paris, Rennes
- Université Paris-Descartes
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Pascal:12-0028197Le document en format XML
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University, Robert Debre University Hospital, Inserm CIC 9202, Paris Sud University, Antoine Béclère University Hospital, and Inserm CIC CBT505</s1><s2>Paris</s2><s3>FRA</s3></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Paris-Descartes</orgName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Inserm SC10, Villejuif; Paris Sud University and Bicetre University Hospital</s1><s2>Le Kremlin-Bicêtre</s2><s3>FRA</s3></inist:fA14><country>France</country><wicri:noRegion>Le Kremlin-Bicêtre</wicri:noRegion><wicri:noRegion>Villejuif; Paris Sud University and Bicetre University Hospital</wicri:noRegion><wicri:noRegion>Le Kremlin-Bicêtre</wicri:noRegion></affiliation><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Franche-Comté University and Saint Jacques Hospital</s1><s2>Besançon</s2><s3>FRA</s3></inist:fA14><country>France</country><placeName><region type="region">Bourgogne-Franche-Comté</region><region type="old region">Franche-Comté</region><settlement type="city">Besançon</settlement></placeName></affiliation><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Rennes 1 University, Rennes University Hospital, and Inserm CIC 02-03</s1><s2>Rennes</s2><s3>FRA</s3></inist:fA14><country>France</country><placeName><region type="region">Région Bretagne</region><region type="old region">Région Bretagne</region><settlement type="city">Rennes</settlement></placeName></affiliation></author><author><name sortKey="Capitant, Catherine" sort="Capitant, Catherine" uniqKey="Capitant C" first="Catherine" last="Capitant">Catherine Capitant</name></author><author><name sortKey="Schmitz, Thomas" sort="Schmitz, Thomas" uniqKey="Schmitz T" first="Thomas" last="Schmitz">Thomas Schmitz</name></author><author><name sortKey="Chazallon, Corine" sort="Chazallon, Corine" uniqKey="Chazallon C" first="Corine" last="Chazallon">Corine Chazallon</name></author><author><name sortKey="Bulifon, Sophie" sort="Bulifon, Sophie" uniqKey="Bulifon S" first="Sophie" last="Bulifon">Sophie Bulifon</name></author><author><name sortKey="Riethmuller, Didier" sort="Riethmuller, Didier" uniqKey="Riethmuller D" first="Didier" last="Riethmuller">Didier Riethmuller</name></author><author><name sortKey="Picone, Olivier" sort="Picone, Olivier" uniqKey="Picone O" first="Olivier" last="Picone">Olivier Picone</name></author><author><name sortKey="Poulain, Patrice" sort="Poulain, Patrice" uniqKey="Poulain P" first="Patrice" last="Poulain">Patrice Poulain</name></author><author><name sortKey="Lewin, Fanny" sort="Lewin, Fanny" uniqKey="Lewin F" first="Fanny" last="Lewin">Fanny Lewin</name></author><author><name sortKey="Laine, Fabrice" sort="Laine, Fabrice" uniqKey="Laine F" first="Fabrice" last="Laine">Fabrice Laine</name></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></author><author><name sortKey="Launay, Odile" sort="Launay, Odile" uniqKey="Launay O" first="Odile" last="Launay">Odile Launay</name></author></analytic><series><title level="j" type="main">Annals of internal medicine</title><title level="j" type="abbreviated">Ann. intern. med.</title><idno type="ISSN">0003-4819</idno><imprint><date when="2011">2011</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Annals of internal medicine</title><title level="j" type="abbreviated">Ann. intern. med.</title><idno type="ISSN">0003-4819</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>2009</term><term>Clinical trial</term><term>Immune response</term><term>Immunoprophylaxis</term><term>Influenza A (H1N1)</term><term>Medicine</term><term>Mother</term><term>Neonatal</term><term>Newborn</term><term>Prevention</term><term>Public health</term><term>Single dose</term><term>Trial</term><term>Vaccine</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Immunoprophylaxie</term><term>Mère</term><term>Réponse immune</term><term>Nouveau né</term><term>Néonatal</term><term>Dose unique</term><term>2009</term><term>Santé publique</term><term>Vaccin</term><term>Prévention</term><term>Essai clinique</term><term>Procès</term><term>Médecine</term><term>Virus grippal A(H1N1)</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Santé publique</term><term>Vaccin</term><term>Médecine</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">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. (Clinical Trials.gov registration number: NCT01024400) Setting: Five level-3 perinatal centers in France. Patients: 107 pregnant women between 22<sup>0/7</sup> and 32<sup>0/7</sup> 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.</div></front></TEI><affiliations><list><country><li>France</li></country><region><li>Bourgogne-Franche-Comté</li><li>Franche-Comté</li><li>Région Bretagne</li><li>Île-de-France</li></region><settlement><li>Besançon</li><li>Paris</li><li>Rennes</li></settlement><orgName><li>Université Paris-Descartes</li></orgName></list><tree><noCountry><name sortKey="Aboulker, Jean Pierre" sort="Aboulker, Jean Pierre" uniqKey="Aboulker J" first="Jean-Pierre" last="Aboulker">Jean-Pierre Aboulker</name><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="Chazallon, Corine" sort="Chazallon, Corine" uniqKey="Chazallon C" first="Corine" last="Chazallon">Corine Chazallon</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="Laine, Fabrice" sort="Laine, Fabrice" uniqKey="Laine F" first="Fabrice" last="Laine">Fabrice Laine</name><name sortKey="Launay, Odile" sort="Launay, Odile" uniqKey="Launay O" first="Odile" last="Launay">Odile Launay</name><name sortKey="Lewin, Fanny" sort="Lewin, Fanny" uniqKey="Lewin F" first="Fanny" last="Lewin">Fanny Lewin</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></noCountry><country name="France"><region name="Île-de-France"><name sortKey="Tsatsaris, Vassilis" sort="Tsatsaris, Vassilis" uniqKey="Tsatsaris V" first="Vassilis" last="Tsatsaris">Vassilis Tsatsaris</name></region><name sortKey="Tsatsaris, Vassilis" sort="Tsatsaris, Vassilis" uniqKey="Tsatsaris V" first="Vassilis" last="Tsatsaris">Vassilis Tsatsaris</name><name sortKey="Tsatsaris, Vassilis" sort="Tsatsaris, Vassilis" uniqKey="Tsatsaris V" first="Vassilis" last="Tsatsaris">Vassilis Tsatsaris</name><name sortKey="Tsatsaris, Vassilis" sort="Tsatsaris, Vassilis" uniqKey="Tsatsaris V" first="Vassilis" last="Tsatsaris">Vassilis Tsatsaris</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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