Evidence map›Paper›PMID 41332801›Full record

ArticlemedRxiv : the preprint server for health sciences2025

Increased dose of H1N1 pandemic influenza vaccine during pregnancy improves immunity in mothers and infants.

Dhvanir Kansara, Martina Kosikova, Patricia L Milletich, Jie Zhou, Lynda Coughlan, Michael S Zens, Geeta Swamy, Anne G Hoen, Hang Xie, Margaret E Ackerman and 2 more

Registry-linked trialAbstract readPreprint
In one paragraph

Article in medRxiv : the preprint server for health sciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00992719 (A Phase II Study In Pregnant Women to Assess the Safety and Immunogenicity of an Unadjuvanted Novartis H1N1 Inactivated Influenza Vaccine Administered at Two Dose Levels), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00992719 phase2completednot on this map

A Phase II Study In Pregnant Women to Assess the Safety and Immunogenicity of an Unadjuvanted Novartis H1N1 Inactivated Influenza Vaccine Administered at Two Dose Levels

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2009 to 2011Enrolled84ConditionsInfluenzaArmsInactivated H1N1 Vaccine
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Dhvanir KansaraDepartment of Microbiology and Immunology, Geisel School of Medicine at Dartmouth College.
Martina KosikovaDivision of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration.
Patricia L MilletichCenter for Vaccine Development, University of Maryland School of Medicine.
Jie ZhouDepartment of Epidemiology, Geisel School of Medicine at Dartmouth College.
Lynda CoughlanCenter for Vaccine Development, University of Maryland School of Medicine.
Michael S ZensDepartment of Epidemiology, Geisel School of Medicine at Dartmouth College.
Geeta SwamyDivision of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Duke University.
Anne G HoenDepartment of Epidemiology, Geisel School of Medicine at Dartmouth College.
Hang XieDivision of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration.
Margaret E AckermanDepartment of Microbiology and Immunology, Geisel School of Medicine at Dartmouth College.
Marcela F PasettiCenter for Vaccine Development, University of Maryland School of Medicine.
DMID 09-0072 Clinical Study Group

Funding

Transferred ImmunityU19AI145825 · NIAID · UNIVERSITY OF MARYLAND BALTIMORE · PI MARCHANT, ARNAUD · 2021 to 2025
$16.0M
NIAID NIH HHS U19 AI145825
6 · The paper itself

Abstract

Maternal-infant immunity against influenza is improved through vaccination during pregnancy. We conducted an in-depth analysis of antibody (Ab) responses in sera from pregnant and non-pregnant women immunized with an unadjuvanted inactivated influenza A (H1N1) monovalent vaccine during the 2009 pandemic (NCT00992719). Pregnant women received either the standard 15μg- or increased 30μg-dose, while non-pregnant women received the 15μg-dose. Ab specific for influenza hemagglutinin (HA), HA stalk, and neuraminidase (NA), as well as canonical functions of hemagglutination inhibition (HAI), microneutralization, and neuraminidase inhibition were examined at baseline, 21 days post-vaccination, at delivery, and in cord blood. Ab subclasses, Fc receptor binding, and Fc-mediated immune functions, including cellular cytotoxicity, phagocytosis, and complement deposition, were also assessed. The vaccine was well-tolerated and highly immunogenic in recipients; most participants had a ≥4-fold increase in Ab titers post-vaccination for HAI (HAI> 70%) and HA-specific IgG (IgG> 50%). Pregnant women who received the 15μg dose had a lower vaccine response in terms of NA-specific IgG and Fc receptor binding compared to the other groups. Immunization of pregnant women with the 30μg-dose resulted in more robust humoral immunity, including a larger number of HA Ab features reaching 4-fold increases compared to the other groups and a more durable antiviral function, and increased NA-specific Ab features that were transferred to the infant as compared to pregnant women who received the standard 15μg-dose. Increasing the antigen content in seasonal vaccines could be a means to enhance immunity against influenza in mothers and infants and deserves further study.

Indexed as

antibodiesH1N1 influenzaPregnancyvaccination

Identifiers

PMID41332801
PMCPMC12668064

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.