tetano
Editor, Senior Moderator
Annals of Internal Medicine
December 6, 2011 vol. 155 no. 11 733-741
Maternal Immune Response and Neonatal Seroprotection From a Single Dose of a Monovalent Nonadjuvanted 2009 Influenza A(H1N1) Vaccine
A Single-Group Trial
Vassilis Tsatsaris, MD, PhD;
Catherine Capitant, MD;
Thomas Schmitz, MD;
Corine Chazallon, MSc;
Sophie Bulifon, MD;
Didier Riethmuller, MD, PhD;
Olivier Picone, MD;
Patrice Poulain, MD, PhD;
Fanny Lewin, MD;
Fabrice Lain?, MD;
Evelyne Jacqz-Aigrain, MD, PhD;
Jean-Pierre Aboulker, MD; and
Odile Launay, MD, PhD,
for the Inserm C09-33 PREFLUVAC (Immunogenicity and Safety of an Inactivated Nonadjuvanted A[H1N1v] Influenza Vaccine in Pregnant Women) Study Group*
+ Author Affiliations
From Universit? Paris Descartes, Assistance Publique?H?pitaux de Paris, H?pital Cochin, PremUP Foundation, Paris Diderot University, Robert Debr? University Hospital, Inserm CIC 9202, Paris Sud University, Antoine B?cl?re University Hospital, and Inserm CIC CBT505, Paris; Inserm SC10, Villejuif; Paris Sud University and Bic?tre University Hospital, Le Kremlin-Bic?tre; Franche-Comt? University and Saint Jacques Hospital, Besan?on; and Rennes 1 University, Rennes University Hospital, and Inserm CIC 02-03, Rennes, France.
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 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.
http://www.annals.org/content/155/11/733.abstract
December 6, 2011 vol. 155 no. 11 733-741
Maternal Immune Response and Neonatal Seroprotection From a Single Dose of a Monovalent Nonadjuvanted 2009 Influenza A(H1N1) Vaccine
A Single-Group Trial
Vassilis Tsatsaris, MD, PhD;
Catherine Capitant, MD;
Thomas Schmitz, MD;
Corine Chazallon, MSc;
Sophie Bulifon, MD;
Didier Riethmuller, MD, PhD;
Olivier Picone, MD;
Patrice Poulain, MD, PhD;
Fanny Lewin, MD;
Fabrice Lain?, MD;
Evelyne Jacqz-Aigrain, MD, PhD;
Jean-Pierre Aboulker, MD; and
Odile Launay, MD, PhD,
for the Inserm C09-33 PREFLUVAC (Immunogenicity and Safety of an Inactivated Nonadjuvanted A[H1N1v] Influenza Vaccine in Pregnant Women) Study Group*
+ Author Affiliations
From Universit? Paris Descartes, Assistance Publique?H?pitaux de Paris, H?pital Cochin, PremUP Foundation, Paris Diderot University, Robert Debr? University Hospital, Inserm CIC 9202, Paris Sud University, Antoine B?cl?re University Hospital, and Inserm CIC CBT505, Paris; Inserm SC10, Villejuif; Paris Sud University and Bic?tre University Hospital, Le Kremlin-Bic?tre; Franche-Comt? University and Saint Jacques Hospital, Besan?on; and Rennes 1 University, Rennes University Hospital, and Inserm CIC 02-03, Rennes, France.
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 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.
http://www.annals.org/content/155/11/733.abstract