0

The full content of Annals is available to subscribers

Subscribe/Learn More  >
Original Research |

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 Lainé, MD; Evelyne Jacqz-Aigrain, MD, PhD; Jean-Pierre Aboulker, MD; 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
[+] Article and Author Information

For a list of Inserm C09-33 PREFLUVAC Study Group members, see the Appendix.


From Université Paris Descartes, Assistance Publique–Hôpitaux de Paris, Hôpital Cochin, PremUP Foundation, Paris Diderot University, Robert Debré University Hospital, Inserm CIC 9202, Paris Sud University, Antoine Béclère University Hospital, and Inserm CIC CBT505, Paris; Inserm SC10, Villejuif; Paris Sud University and Bicêtre University Hospital, Le Kremlin-Bicêtre; Franche-Comté University and Saint Jacques Hospital, Besançon; and Rennes 1 University, Rennes University Hospital, and Inserm CIC 02-03, Rennes, France.


Presented in part at the 50th Interscience Conference on Antimicrobial Agents and Chemotherapy, Boston, Massachusetts, 12–15 September 2010.

Acknowledgment: The authors thank the study participants and the participating clinicians at each site. They also thank Francis Beauvais, MD, PhD, for help in preparing the manuscript and Martine Denis, MD, PhD, for help in discussing the data.

Grant Support: By the French National Institute of Health and Medical Research and a grant from the programme de recherches H1N1 Aviesan–Institut de Microbiologie et des Maladies Infectieuses. Sanofi Pasteur provided the vaccines and performed immunologic tests.

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M11-0779.

Reproducible Research Statement:Study protocol: Available in French from Dr. Launay (e-mail, odile.launay@cch.aphp.fr). Statistical code and data set: Not available.

Requests for Single Reprints: Odile Launay, MD, PhD, CIC de Vaccinologie Cochin Pasteur, Bâtiment Lavoisier, Groupe Hospitalier Cochin–Saint Vincent de Paul, 27 Rue du Faubourg St. Jacques, 75679 Paris Cedex 14, France; e-mail, odile.launay@cch.aphp.fr.

Current Author Addresses: Drs. Tsatsaris and Lewin: Maternité Port Royal, Groupe Hospitalier Cochin–Saint Vincent de Paul, 27 Rue du Faubourg St. Jacques, 75679 Paris Cedex 14, France.

Drs. Capitant and Aboulker and Ms. Chazallon: Inserm SC10, 16 Avenue Paul Vaillant Couturier, 94807 Villejuif Cedex, France.

Dr. Schmitz: Maternité, Hôpital Robert Debré, 48 Boulevard Sérurier, 75935 Paris Cedex 19, France.

Drs. Bulifon and Launay: CIC de Vaccinologie Cochin Pasteur, Bâtiment Lavoisier, Groupe Hospitalier Cochin–Saint Vincent de Paul, 27 Rue du Faubourg St. Jacques, 75679 Paris Cedex 14, France.

Dr. Riethmuller: Service de Gynécologie Obstétrique, CHU de Besançon–Hôpital Saint-Jacques, 2 Place Saint-Jacques, 25030 Besançon Cedex, France.

Dr. Picone: Service Gynécologie-Obstétrique, Hôpital Antoine Béclère, 157 Rue de la Porte de Trivaux, 92141 Clamart Cedex, France.

Dr. Poulain: Service Obstétrique, Hôpital Sud, 16 Boulevard de Bulgarie, 35000 Rennes, France.

Dr. Lainé: CIC P0203, Hôpital Pontchaillou, Pavillon Clémenceau, 2 Rue Henri Le Guilloux, 35033 Rennes Cedex 9, France.

Dr. Jacqz-Aigrain: CIC Mère-Enfant, Hôpital Robert Debré, 48 Boulevard Sérurier, 75935 Paris Cedex 19, France.

Author Contributions: Conception and design: V. Tsatsaris, C. Capitant, C. Chazallon, D. Riethmuller, J.P. Aboulker, O. Launay.

Analysis and interpretation of the data: V. Tsatsaris, C. Capitant, T. Schmitz, C. Chazallon, F. Lainé, E. Jacqz-Aigrain, J.P. Aboulker, O. Launay.

Drafting of the article: V. Tsatsaris, C. Capitant, T. Schmitz, C. Chazallon, D. Riethmuller, F. Lainé, E. Jacqz-Aigrain, O. Launay.

Critical revision of the article for important Intellectual content: V. Tsatsaris, T. Schmitz, D. Riethmuller, E. Jacqz-Aigrain, J.P. Aboulker, O. Launay.

Final approval of the article: V. Tsatsaris, C. Capitant, T. Schmitz, C. Chazallon, S. Bulifon, D. Riethmuller, O. Picone, F. Lainé, E. Jacqz-Aigrain, J.P. Aboulker, O. Launay.

Provision of study materials or patients: V. Tsatsaris, T. Schmitz, S. Bulifon, D. Riethmuller, O. Picone, P. Poulain, F. Lewin, E. Jacqz-Aigrain, O. Launay.

Statistical expertise: C. Chazallon, E. Jacqz-Aigrain, J.P. Aboulker.

Obtaining of funding: O. Launay.

Administrative, technical, or logistic support: C. Capitant, F. Lainé, E. Jacqz-Aigrain.

Collection and assembly of data: V. Tsatsaris, C. Capitant, C. Chazallon, D. Riethmuller, O. Picone, E. Jacqz-Aigrain, O. Launay.


Ann Intern Med. 2011;155(11):733-741. doi:10.7326/0003-4819-155-11-201112060-00005
Text Size: A A A

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.

Tables

References

Letters

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Comments

Submit a Comment
Submit a Comment

Summary for Patients

Influenza Vaccine to Protect Mothers and Their Babies

The full report is titled “Maternal Immune Response and Neonatal Seroprotection From Single Dose of a Monovalent Nonadjuvanted 2009 Influenza A(H1N1) Vaccine. A Single-Group Trial.” It is in the 6 December 2011 issue of Annals of Internal Medicine (volume 155, pages 733-741). The authors are V. Tsatsaris, C. Capitant, T. Schmitz, C. Chazallon, S. Bulifon, D. Riethmuller, O. Picone, P. Poulain, F. Lewin, F. Lainé, E. Jacqz-Aigrain, J.P. Aboulker, and O. Launay, for the Inserm C09-33 PREFLUVAC (Immunogenicity and Safety of an Inactivated Nonadjuvanted A[H1N1v] Influenza Vaccine in Pregnant Women) Study Group.

Read More...

Clinical Slide Sets

Terms of Use

The In the Clinic® slide sets are owned and copyrighted by the American College of Physicians (ACP). All text, graphics, trademarks, and other intellectual property incorporated into the slide sets remain the sole and exclusive property of the ACP. The slide sets may be used only by the person who downloads or purchases them and only for the purpose of presenting them during not-for-profit educational activities. Users may incorporate the entire slide set or selected individual slides into their own teaching presentations but may not alter the content of the slides in any way or remove the ACP copyright notice. Users may make print copies for use as hand-outs for the audience the user is personally addressing but may not otherwise reproduce or distribute the slides by any means or media, including but not limited to sending them as e-mail attachments, posting them on Internet or Intranet sites, publishing them in meeting proceedings, or making them available for sale or distribution in any unauthorized form, without the express written permission of the ACP. Unauthorized use of the In the Clinic slide sets will constitute copyright infringement.

Toolkit

Buy Now

to gain full access to the content and tools.

Want to Subscribe?

Learn more about subscription options

Advertisement
Related Articles
Related Point of Care
Topic Collections
PubMed Articles

Buy Now

to gain full access to the content and tools.

Want to Subscribe?

Learn more about subscription options

Forgot your password?
Enter your username and email address. We'll send you a reminder to the email address on record.
(Required)
(Required)