Evidence map›Paper›PMID 35732186›Full record

Trial reportThe Journal of infectious diseases2022

Evaluation of Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV/ΔNS2/Δ1313/I1314L and RSV/276 in RSV-Seronegative Children.

Coleen K Cunningham, Ruth A Karron, Petronella Muresan, Matthew S Kelly, Elizabeth J McFarland, Charlotte Perlowski, Jennifer Libous, Jennifer Oliva, Patrick Jean-Philippe, Jack Moye and 14 more

2 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2022. 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 39 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 2 pooled it
6.5field-weighted citation impact, top 2% 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.

NCT03227029 phase1completednot on this map

Randomized Phase I Study of the Infectivity, Safety, and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Infants 6 to 24 Months of Age

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2017 to 2020Enrolled65ConditionsRespiratory Syncytial Virus InfectionsArmsRSV ΔNS2/Δ1313/I1314L, RSV 276, Placebo
NCT03422237 no registry record found
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 2 syntheses or guidelines pooled it, 43 citations in OpenAlex.

  1. Pooled it
  2. Efficacy and safety of respiratory syncytial virus vaccines.The Cochrane database of systematic reviews · 2025
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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

24 authors at 13 institutions in 1 country.

Coleen K CunninghamDepartment of Pediatrics, Duke University Medical Center, Durham, North Carolina, USA.ORCID 0000-0002-7725-3052
Ruth A KarronCenter for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Petronella MuresanStatistical and Data Management Center/Frontier Science and Technology Research Foundation, Brookline, Massachusetts, USA.
Matthew S KellyDepartment of Pediatrics, Duke University Medical Center, Durham, North Carolina, USA.
Elizabeth J McFarlandDepartment of Pediatrics, University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, Colorado, 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.
Benjamin JohnstonFrontier Science and Technology Research Foundation, Buffalo, New York, USA.
Ellen G ChadwickDepartment of Pediatrics, Northwestern University Feinberg School of Medicine and Ann and Robert H. Lurie Children's Hospital of Chicago, 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.
Mary PaulDepartment of Pediatrics, Baylor College of Medicine, Houston, Texas, USA.
Jaime G DevilleDavid Geffen School of Medicine at University of California, Los Angeles, California, USA.
Mariam AzizRush University Medical Center, Cook County Hospital, Chicago, Illinois, 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.
International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) 2018 Study Team
National Institutes of Health · USJohns Hopkins University · USChildren's Hospital Colorado · USFamily Health International 360 · USFrontier Science & Technology Research Foundation · USBaylor College of Medicine · USChildren's Hospital of Orange County · USDuke Medical Center · USJohns Hopkins Hospital · USNorthwestern University · USRush University Medical Center · 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
University of California, San Diego Clinical Trial UnitUM1AI069536 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI STEPHEN A SPECTOR · 2012 to 2026
$34.0M
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
Evaluation of a Candidate Therapeutic for Dengue Virus75N93019D00031 · NIAID · JOHNS HOPKINS UNIVERSITY · PI DURBIN, ANNA PALMER · 2019 to 2024
$5.8M
NCATS NIH HHS UL1 TR002535NIAID NIH HHS 75N93019D00031NIAID NIH HHS HHSN272200900010CNIAID NIH HHS P30 AI064518NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI069536NICHD NIH HHS HHSN275201800001CNICHD NIH HHS HHSN275201800001INIH HHS UM1AI068632
6 · The paper itself

Abstract

backgroundThis United States-based study compared 2 candidate vaccines: RSV/ΔNS2/Δ1313/I1314L, attenuated by NS2 gene-deletion and temperature-sensitivity mutation in the polymerase gene; and RSV/276, attenuated by M2-2 deletion.

methodsRSV-seronegative children aged 6-24 months received RSV/ΔNS2/Δ1313/I1314L (106 plaque-forming units [PFU]), RSV/276 (105 PFU), or placebo intranasally. Participants were monitored for vaccine shedding, reactogenicity, and RSV serum antibodies, and followed over the subsequent RSV season.

resultsEnrollment occurred September 2017 to October 2019. During 28 days postinoculation, upper respiratory illness and/or fever occurred in 64% of RSV/ΔNS2/Δ1313/I1314L, 84% of RSV/276, and 58% of placebo recipients. Symptoms were generally mild. Cough was more common in RSV/276 recipients than RSV/ΔNS2/Δ1313/I1314L (48% vs 12%; P = .012) or placebo recipients (17%; P = .084). There were no lower respiratory illness or serious adverse events. Eighty-eight and 96% of RSV/ΔNS2/Δ1313/I1314L and RSV/276 recipients were infected with vaccine (shed vaccine and/or had ≥4-fold rises in RSV antibodies). Serum RSV-neutralizing titers and anti-RSV F IgG titers increased ≥4-fold in 60% and 92% of RSV/ΔNS2/Δ1313/I1314L and RSV/276 vaccinees, respectively. Exposure to community RSV during the subsequent winter was associated with strong anamnestic RSV-antibody responses.

conclusionsBoth vaccines had excellent infectivity and were well tolerated. RSV/276 induced an excess of mild cough. Both vaccines were immunogenic and primed for strong anamnestic responses. CLINICAL TRIALS REGISTRATION: NCT03227029 and NCT03422237.

Indexed as

Respiratory Syncytial Virus, HumanRespiratory Syncytial Virus InfectionsRespiratory Syncytial Virus VaccinesAntibodies, NeutralizingAntibodies, ViralChildCoughHumansRespiratory Syncytial VirusesVaccines, AttenuatedAntibodies, NeutralizingAntibodies, ViralRespiratory Syncytial Virus VaccinesVaccines, Attenuatedimmunogenicitylive-attenuated viral vaccineneutralizing antibodiesrespiratory syncytial virusRNA regulatory protein M2-2RSV

Identifiers

PMID35732186
PMCPMC10205613
OpenAlexW4283321707

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.