Evidence map›Paper›PMID 31758177›Full record

Trial reportThe Journal of infectious diseases2020

Live Respiratory Syncytial Virus Attenuated by M2-2 Deletion and Stabilized Temperature Sensitivity Mutation 1030s Is a Promising Vaccine Candidate in Children.

Elizabeth J McFarland, Ruth A Karron, Petronella Muresan, Coleen K Cunningham, Jennifer Libous, Charlotte Perlowski, Bhagvanji Thumar, Devasena Gnanashanmugam, Jack Moye, Elizabeth Schappell and 11 more

Open access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of infectious diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 3 pooled it
2.9field-weighted citation impact, top 9% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 3 syntheses or guidelines pooled it, 47 citations in OpenAlex.

  1. Efficacy and safety of respiratory syncytial virus vaccines.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Vaccines for the common cold.The Cochrane database of systematic reviews · 2022
    Pooled it
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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

21 authors at 15 institutions in 1 country.

Elizabeth J McFarlandDepartment of Pediatrics, University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, Colorado, USA.
Ruth A KarronCenter for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Petronella MuresanCenter for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health/Frontier Science, Boston, Massachusetts, USA.
Coleen K CunninghamDepartment of Pediatrics, Duke University Medical Center, Durham, North Carolina, USA.
Jennifer LibousFHI 360, Durham, North Carolina, USA.
Charlotte PerlowskiFHI 360, Durham, North Carolina, USA.
Bhagvanji ThumarCenter for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Devasena GnanashanmugamMaternal, Adolescent and Pediatric Research Branch, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Jack MoyeEunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, USA.
Elizabeth SchappellCenter for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Emily BarrDepartment of Pediatrics, University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, Colorado, USA.
Vivian RexroadInvestigational Drug Service Pharmacy, Johns Hopkins Hospital, Baltimore, Maryland, USA.
Laura FearnDepartment of Pediatrics, Northwestern University Medical School and Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, USA.
Stephen A SpectorDepartment of Pediatrics, University of California San Diego, La Jolla, California, USA.
Mariam AzizSection of Infectious Disease, Rush University Medical Center, Chicago, Illinois, USA.
Mikhaela CieloDivision of Infectious Diseases, Maternal Child and Adolescent Center, University of Southern California Keck School of Medicine, Los Angeles, California, USA.
Christy BeneriDepartment of Pediatrics, SUNY Stony Brook, Stony Brook, New York, USA.
Andrew WizniaDepartment of Pediatrics, Albert Einstein College of Medicine and Jacobi Medical Center, Bronx, New York, USA.
Cindy LuongoLaboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Peter CollinsLaboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Ursula J BuchholzLaboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Johns Hopkins University · USNational Institutes of Health · USFamily Health International 360 · USUniversity of Colorado Denver · USCancer Research And Biostatistics · USDuke Medical Center · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USJacobi Medical Center · USJohns Hopkins Hospital · USNational Institute of Allergy and Infectious Diseases · USNorthwestern University · USRady Children's Hospital-San Diego · USRush University Medical Center · USStony Brook University · USUniversity of Southern California · US

Funding

LOC-IMPAACT Leadership GroupPharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the USUM1AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI Sharon A Nachman · 2011 to 2026
$278.1M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGUM1AI068616 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Sean Scott Brummel, Marlene Ann Cooper · 2011 to 2026
$155.6M
NIH Prior Approval Process ProfessionalUL1TR002535 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2018 to 2022
$51.1M
Social and Behavioral Sciences CoreP30AI064518 · NIAID · DUKE UNIVERSITY · PI GEORGIA Doris TOMARAS · 2005 to 2026
$50.5M
LC - IMPAACT Leadership GroupUM1AI106716 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$47.2M
Clinical Trials of Vaccines for Respiratory Syncytial Virus and Related VirusesZIAAI000326 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI BUCHHOLZ, URSULA · 2009 to 2025
$33.1M
NCATS NIH HHS UL1 TR002535NIAID NIH HHS HHSN272200900010CNIAID NIH HHS P30 AI064518NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1 AI106716NICHD NIH HHS HHSN275201800001CNICHD NIH HHS HHSN275201800001I
6 · The paper itself

Abstract

backgroundThe safety and immunogenicity of live respiratory syncytial virus (RSV) candidate vaccine, LID/ΔM2-2/1030s, with deletion of RSV ribonucleic acid synthesis regulatory protein M2-2 and genetically stabilized temperature-sensitivity mutation 1030s in the RSV polymerase protein was evaluated in RSV-seronegative children.

methodsRespiratory syncytial virus-seronegative children ages 6-24 months received 1 intranasal dose of 105 plaque-forming units (PFU) of LID/ΔM2-2/1030s (n = 21) or placebo (n = 11). The RSV serum antibodies, vaccine shedding, and reactogenicity were assessed. During the following RSV season, medically attended acute respiratory illness (MAARI) and pre- and postsurveillance serum antibody titers were monitored.

resultsEighty-five percent of vaccinees shed LID/ΔM2-2/1030s vaccine (median peak nasal wash titers: 3.1 log10 PFU/mL by immunoplaque assay; 5.1 log10 copies/mL by reverse-transcription quantitative polymerase chain reaction) and had ≥4-fold rise in serum-neutralizing antibodies. Respiratory symptoms and fever were common (60% vaccinees and 27% placebo recipients). One vaccinee had grade 2 wheezing with rhinovirus but without concurrent LID/ΔM2-2/1030s shedding. Five of 19 vaccinees had ≥4-fold increases in antibody titers postsurveillance without RSV-MAARI, indicating anamnestic responses without significant illness after infection with community-acquired RSV.

conclusionsLID/ΔM2-2/1030s had excellent infectivity without evidence of genetic instability, induced durable immunity, and primed for anamnestic antibody responses, making it an attractive candidate for further evaluation.

Indexed as

Gene DeletionVaccinationAntibodies, NeutralizingAntibodies, ViralBody TemperatureDouble-Blind MethodFemaleHumansImmunogenicity, VaccineInfantMalePoint MutationRespiratory Syncytial Virus, HumanRespiratory Syncytial Virus InfectionsRespiratory Syncytial Virus VaccinesRNA-Dependent RNA PolymeraseAntibodies, NeutralizingAntibodies, ViralM2-2 protein, respiratory syncytial virusRespiratory Syncytial Virus VaccinesRNA-Dependent RNA PolymeraseVaccines, AttenuatedViral Proteinslive-attenuated viral vaccineneutralizing antibodiespediatric RSV vaccinerespiratory syncytial virus (RSV)RNA regulatory protein M2-2

Identifiers

PMID31758177
PMCPMC6996856
OpenAlexW2989749580

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.