Evidence map›Paper›PMID 32006006›Full record

Trial reportThe Journal of infectious diseases2020

Live-Attenuated Respiratory Syncytial Virus Vaccine With M2-2 Deletion and With Small Hydrophobic Noncoding Region Is Highly Immunogenic in Children.

Elizabeth J McFarland, Ruth A Karron, Petronella Muresan, Coleen K Cunningham, Charlotte Perlowski, Jennifer Libous, Jennifer Oliva, Patrick Jean-Philippe, Jack Moye, Elizabeth Schappell and 10 more

2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
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. It is linked to 2 registered trials, which are not on this map. Cited by 41 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 3 pooled it
4.5field-weighted citation impact, top 4% 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.

NCT03099291 no registry record found
NCT03102034 phase1completednot on this map

Phase I Placebo-Controlled Study of the Infectivity, Safety and Immunogenicity of a Single Dose of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, D46/NS2/N/ΔM2-2-HindIII, Lot RSV#011B, Delivered as Nose Drops to RSV-Seronegative Infants 6 to 24 Months of Age

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2017 to 2018Enrolled32ConditionsRespiratory Syncytial Virus InfectionsArmsD46/NS2/N/ΔM2-2-HindIII, Placebo
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 3 syntheses or guidelines pooled it, 53 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
  3. Pooled it
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  15. A Rapid Yeast-Based System for Modifying Respiratory Syncytial Virus.Methods in molecular biology (Clifton, N.J.) · 2025
    Article
  16. Review
  17. Article
  18. Review
  19. Antibody-mediated protection against respiratory syncytial virus in children.European respiratory review : an official journal of the European Respiratory Society · 2024
    Review
  20. Review
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

20 authors at 12 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 Foundation, Boston, Massachusetts, USA.
Coleen K CunninghamDepartment of Pediatrics, Duke University Medical Center, Durham, North Carolina, USA.
Charlotte PerlowskiFHI 360, Durham, North Carolina, USA.
Jennifer LibousFHI 360, Durham, North Carolina, USA.
Jennifer OlivaCenter for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Patrick Jean-PhilippeMaternal, 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.
Mikhaela CieloDivision of Infectious Diseases, Maternal Child & Adolescent Center, University of Southern California Keck School of Medicine, Los Angeles, California, USA.
Andrew WizniaDepartment of Pediatrics, Albert Einstein College of Medicine and Jacobi Medical Center, Bronx, New York, USA.
Jaime G DevilleDavid Geffen School of Medicine at University of California Los Angeles, California, USA.
Lijuan YangLaboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Cindy LuongoLaboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Peter L 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 · USNational Institute of Allergy and Infectious Diseases · USUniversity of Colorado Anschutz Medical Campus · USAlbert Einstein College of Medicine · USDuke Medical Center · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USJohns Hopkins Hospital · USNorthwestern University · USUniversity of California, Los Angeles · 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 HHSN275201800001I
6 · The paper itself

Abstract

backgroundRespiratory syncytial virus (RSV) is the leading viral cause of severe pediatric respiratory illness, and vaccines are needed. Live RSV vaccine D46/NS2/N/ΔM2-2-HindIII, attenuated by deletion of the RSV RNA regulatory protein M2-2, is based on previous candidate LID/ΔM2-2 but incorporates prominent differences from MEDI/ΔM2-2, which was more restricted in replication in phase 1.

methodsRSV-seronegative children aged 6-24 months received 1 intranasal dose (105 plaque-forming units [PFUs] of D46/NS2/N/ΔM2-2-HindIII [n = 21] or placebo [n = 11]) and were monitored for vaccine shedding, reactogenicity, RSV-antibody responses and RSV-associated medically attended acute respiratory illness (RSV-MAARI) and antibody responses during the following RSV season.

resultsAll 21 vaccinees were infected with vaccine; 20 (95%) shed vaccine (median peak titer, 3.5 log10 PFUs/mL with immunoplaque assay and 6.1 log10 copies/mL with polymerase chain reaction). Serum RSV-neutralizing antibodies and anti-RSV fusion immunoglobulin G increased ≥4-fold in 95% and 100% of vaccines, respectively. Mild upper respiratory tract symptoms and/or fever occurred in vaccinees (76%) and placebo recipients (18%). Over the RSV season, RSV-MAARI occurred in 2 vaccinees and 4 placebo recipients. Three vaccinees had ≥4-fold increases in serum RSV-neutralizing antibody titers after the RSV season without RSV-MAARI.

conclusionsD46/NS2/N/ΔM2-2-HindIII had excellent infectivity and immunogenicity and primed vaccine recipients for anamnestic responses, encouraging further evaluation of this attenuation strategy. CLINICAL TRIALS REGISTRATION: NCT03102034 and NCT03099291.

Indexed as

AdolescentAntibodies, NeutralizingAntibodies, ViralChildGene DeletionHumansHydrophobic and Hydrophilic InteractionsRespiratory Syncytial Virus, HumanRespiratory Syncytial Virus InfectionsRespiratory Syncytial Virus VaccinesRNA, Small UntranslatedRNA, ViralVaccines, AttenuatedViral ProteinsAntibodies, NeutralizingAntibodies, ViralM2-2 protein, respiratory syncytial virusRespiratory Syncytial Virus VaccinesRNA, Small UntranslatedRNA, ViralVaccines, AttenuatedViral Proteinsimmunogenicitylive-attenuated viral vaccineneutralizing antibodiespediatric RSV vaccinerespiratory syncytial virusRNA regulatory protein M2-2

Identifiers

PMID32006006
PMCPMC7289559
OpenAlexW3004006053

What OpenQuestion holds

Textmetadata
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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.