Evidence map›Paper›PMID 32868130›Full record

ArticleVaccine2020

Immunogenicity of influenza vaccines administered to pregnant women in randomized clinical trials in Mali and South Africa.

Avnika B Amin, Marta C Nunes, Milagritos D Tapia, Shabir A Madhi, Clare L Cutland, Niteen Wairagkar, Saad B Omer, for BMGF Supported Maternal Influenza Immunization Trials Investigators Group

2 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Vaccine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 25% of its field
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.

NCT01306669 phase3completednot on this map

Vaccination of HIV-uninfected Pregnant Women With Trivalent Influenza Vaccine in the Prevention of Influenza Illness During Early Infancy and in Mothers: Randomized Controlled Phase III Trial Evaluating Safety, Immunogenicity and Efficacy

TypeinterventionalSponsorUniversity of Witwatersrand, South AfricaRan2011 to 2013Enrolled2,116ConditionsInfluenzaArmsTrivalent influenza vaccine, Normal saline
NCT01430689 phase4completednot on this map

Prospective, Randomized, Controlled, Observer-Blind Trial to Measure the Efficacy, Safety and Immunogenicity of Trivalent Inactivated Influenza Vaccine and the Safety and Immunogenicity of Quadrivalent Meningococcal Polysaccharide Diphtheria Conjugate Vaccine in Pregnant Malian Women and Their Infants up to 6 Months of Age

TypeinterventionalSponsorUniversity of Maryland, BaltimoreRan2011 to 2014Enrolled4,193ConditionsInfluenzaArmsInactivated Influenza Vaccine Trivalent Types A and B, Meningococcal Polysaccharide-Diphtheria Toxoid Conjugate Vaccine
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 3 countries.

Avnika B AminDepartment of Epidemiology, Emory University Rollins School of Public Health, Atlanta, USA. Electronic address: avnika.amin@emory.edu.
Marta C NunesMedical Research Council: Respiratory and Meningeal Pathogens Research Unit, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology-National Research Foundation, Vaccine-Preventable Diseases, Johannesburg, South Africa.
Milagritos D TapiaCentre pour le Développement des Vaccins, Bamako, Mali; University of Maryland School of Medicine, Center for Vaccine Development, Baltimore, USA.
Shabir A MadhiMedical Research Council: Respiratory and Meningeal Pathogens Research Unit, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology-National Research Foundation, Vaccine-Preventable Diseases, Johannesburg, South Africa.
Clare L CutlandMedical Research Council: Respiratory and Meningeal Pathogens Research Unit, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology-National Research Foundation, Vaccine-Preventable Diseases, Johannesburg, South Africa.
Niteen WairagkarBill & Melinda Gates Foundation, Seattle, USA.
Saad B OmerDepartment of Epidemiology, Emory University Rollins School of Public Health, Atlanta, USA; Hubert Department of Global Health, Emory University Rollins School of Public Health, Atlanta, USA; Emory Vaccine Center, Atlanta, USA; Department of Pediatrics, Emory University School of Medicine, Atlanta, USA.
for BMGF Supported Maternal Influenza Immunization Trials Investigators Group
University of the Witwatersrand · ZAEmory Healthcare · USEmory University · USGates Foundation · USUniversity of Maryland, Baltimore · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

backgroundA key consideration for expanding recommendations for influenza vaccination is a robust assessment of immunogenicity and efficiency of transplacental antibody transfer after maternal vaccination.

methodsWe pooled data from two trials of maternal influenza vaccination to analyze vaccine immunogenicity with more power than either trial had alone. We compared hemagglutination-inhibition (HAI) titers and titer factor change for women and their infants between trial arms using t-tests; maternal and infant putative seroprotective titers (HAI ≥ 1:40) within each trial arm and maternal seroconversion between trial arms using exact tests; and transplacental antibody transfer between trial arms using t-tests. We used marginal linear models and generalized estimating equations to examine the impact of time between maternal vaccination and delivery on transplacental antibody transfer, infant titers, and infant seroprotection.

resultsFor all vaccine components (A/H1N1, A/H3N2, and Type B), >80% of vaccinated women had seroprotective titers, >60% of them seroconverted, and >50% of their infants were born with seroprotective titers. These immunogenicity outcomes occurred more often in vaccine recipients and their infants than in controls. No difference in efficiency of transplacental antibody transfer was observed between vaccine recipients and controls.

conclusionsOur results provide robust support for further expansion of maternal influenza vaccination recommendations. CLINICAL TRIALS REGISTRATION: NCT01430689 and NCT01306669.

Indexed as

Influenza A Virus, H1N1 SubtypeInfluenza, HumanInfluenza VaccinesAntibodies, ViralFemaleHemagglutination Inhibition TestsHumansInfantInfluenza A Virus, H3N2 SubtypeMaliPregnancyPregnant PeopleRandomized Controlled Trials as TopicSouth AfricaAntibodies, ViralInfluenza VaccinesImmunogenicityInfluenzaInfluenza vaccineMaternal vaccinationTransplacental antibody transfer

Identifiers

PMID32868130
PMCPMC7505225
OpenAlexW3082467843

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.