tetano
Editor, Senior Moderator
Ann Intern Med. 2011 Dec 6;155(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.
Tsatsaris V, Capitant C, Schmitz T, Chazallon C, Bulifon S, Riethmuller D, Picone O, Poulain P, Lewin F, Lain? F, Jacqz-Aigrain E, Aboulker JP, Launay O; for the Inserm C09-33 PREFLUVAC (Immunogenicity and Safety of an Inactivated Nonadjuvanted A[H1N1v] Influenza Vaccine in Pregnant Women) Study Group.
Source
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, Besancon; 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 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.
PMID:
22147712
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/22147712
Maternal Immune Response and Neonatal Seroprotection From a Single Dose of a Monovalent Nonadjuvanted 2009 Influenza A(H1N1) Vaccine: A Single-Group Trial.
Tsatsaris V, Capitant C, Schmitz T, Chazallon C, Bulifon S, Riethmuller D, Picone O, Poulain P, Lewin F, Lain? F, Jacqz-Aigrain E, Aboulker JP, Launay O; for the Inserm C09-33 PREFLUVAC (Immunogenicity and Safety of an Inactivated Nonadjuvanted A[H1N1v] Influenza Vaccine in Pregnant Women) Study Group.
Source
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, Besancon; 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 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.
PMID:
22147712
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/22147712