Evidence map›Paper›PMID 29509911›Full record

Trial reportThe Journal of infectious diseases2018

Live-Attenuated Respiratory Syncytial Virus Vaccine Candidate With Deletion of RNA Synthesis Regulatory Protein M2-2 is Highly Immunogenic in Children.

Elizabeth J McFarland, Ruth A Karron, Petronella Muresan, Coleen K Cunningham, Megan E Valentine, Charlotte Perlowski, Bhagvanji Thumar, Devasena Gnanashanmugam, George K Siberry, Elizabeth Schappell and 11 more

2 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of infectious diseases, 2018. 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 47 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 3 pooled it
5.2field-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.

NCT02040831 phase1completednot on this map

A Phase I Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV LID ΔM2-2, Lot RSV#007A, Delivered as Nose Drops to RSV-Seronegative Infants and Children 6 to 24 Months of Age

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2014 to 2015Enrolled3ConditionsRespiratory Syncytial Virus InfectionsArmsRSV LID ΔM2-2 Vaccine, Placebo Vaccine
NCT02237209 phase1completednot on this map

A Phase I Study of the Safety and Immunogenicity of Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV LID ΔM2-2 in RSV-Seronegative Infants and Children

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2014 to 2015Enrolled29ConditionsRespiratory Syncytial Virus InfectionsArmsRSV LID ΔM2-2 Vaccine, Placebo Vaccine
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 3 syntheses or guidelines pooled it, 70 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
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 14 institutions in 1 country.

Elizabeth J McFarlandDepartment of Pediatrics, University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora.
Ruth A KarronCenter for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
Petronella MuresanStatistical and Data Analysis Center, Harvard School of Public Health, Boston, Massachusetts.
Coleen K CunninghamDepartment of Pediatrics, Duke University Medical Center.
Megan E ValentineFHI 360, Durham, North Carolina.
Charlotte PerlowskiFHI 360, Durham, North Carolina.
Bhagvanji ThumarCenter for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
Devasena GnanashanmugamMaternal, Adolescent and Pediatric Research Branch, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda.
George K SiberryEunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda.
Elizabeth SchappellCenter for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
Emily BarrDepartment of Pediatrics, University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora.
Vivian RexroadInvestigational Drug Service Pharmacy, Johns Hopkins Hospital, Baltimore, Maryland.
Ram YogevDepartment of Pediatrics, Northwestern University Medical School and Ann and Robert H. Lurie Children's Hospital of Chicago, Illinois.
Stephen A SpectorDepartment of Pediatrics, University of California San Diego, La Jolla.
Mariam AzizSection of Infectious Disease, Rush University Medical Center, Chicago, Illinois.
Nehali PatelDepartment of Pediatrics, St. Jude Children's Research Hospital, Memphis, Tennessee.
Mikhaela CieloDivision of Infectious Diseases, Maternal Child and Adolescent Center, University of Southern California Keck School of Medicine, Los Angeles.
Cindy LuongoLaboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryl.
Peter L CollinsLaboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryl.
Ursula J BuchholzLaboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryl.
International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) 2000 Study Team
Johns Hopkins University · USNational Institutes of Health · USFamily Health International 360 · USNational Institute of Allergy and Infectious Diseases · USChildren's Hospital Colorado · USDuke Medical Center · USHarvard University · USJohns Hopkins Hospital · USNorthwestern University · USRush University Medical Center · USSt. Jude Children's Research Hospital · USUniversity of California, San Diego · USUniversity of Colorado Denver · 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 Jennifer Jao, 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
Social and Behavioral Sciences CoreP30AI064518 · NIAID · DUKE UNIVERSITY · PI GEORGIA Doris TOMARAS · 2005 to 2026
$50.5M
Colorado Clinical and Translational Sciences InstituteUL1TR001082 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2013 to 2017
$48.0M
LC - IMPAACT Leadership GroupUM1AI106716 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$47.2M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGU01AI068616 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI SHAPIRO, DAVID ERIC · 2006 to 2010
$38.6M
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 TR001082NIAID NIH HHS P30 AI064518NIAID NIH HHS U01 AI068616NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1 AI106716
6 · The paper itself

Abstract

Background: Live respiratory syncytial virus (RSV) candidate vaccine LIDΔM2-2 is attenuated by deletion of the RSV RNA regulatory protein M2-2, resulting in upregulated viral gene transcription and antigen expression but reduced RNA replication. Methods: RSV-seronegative children ages 6-24 months received a single intranasal dose of 105 plaque forming units (PFU) of LIDΔM2-2 (n = 20) or placebo (n = 9) (NCT02237209, NCT02040831). RSV serum antibodies, vaccine infectivity, and reactogenicity were assessed. During the following RSV season, participants were monitored for respiratory illness and pre- and post-RSV season serum antibodies. Results: Vaccine virus was shed by 95% of vaccinees (median peak titers of 3.8 log10 PFU/mL by quantitative culture and 6.3 log10 copies/mL by PCR); 90% had ≥4-fold rise in serum neutralizing antibodies. Respiratory symptoms and fever were common in vaccine (95%) and placebo (78%). One vaccinee had grade 2 rhonchi concurrent with vaccine shedding, rhinovirus, and enterovirus. Eight of 19 vaccinees versus 2 of 9 placebo recipients had substantially increased RSV antibody titers after the RSV season without medically attended RSV disease, indicating anamnestic vaccine responses to wild-type RSV without significant illness. Conclusion: LIDΔM2-2 had excellent infectivity and immunogenicity, encouraging further study of vaccine candidates attenuated by M2-2 deletion. Clinical Trials Registration: NCT02237209, NCT02040831.

Indexed as

Antibodies, NeutralizingAntibodies, ViralDouble-Blind MethodFemaleHumansInfantMaleRespiratory Syncytial Virus, HumanRespiratory Syncytial Virus InfectionsRespiratory Syncytial Virus VaccinesVaccines, AttenuatedViral ProteinsVirus ReplicationAntibodies, NeutralizingAntibodies, ViralM2-2 protein, respiratory syncytial virusRespiratory Syncytial Virus VaccinesVaccines, AttenuatedViral Proteins

Identifiers

PMID29509911
PMCPMC5894092
OpenAlexW2789458933

What OpenQuestion holds

Textmetadata
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.