Evidence map›Paper›PMID 37468530›Full record

Trial reportNature communications2023

Molecular and phenotypic characteristics of RSV infections in infants during two nirsevimab randomized clinical trials.

Bahar Ahani, Kevin M Tuffy, Anastasia A Aksyuk, Deidre Wilkins, Michael E Abram, Ron Dagan, Joseph B Domachowske, Johnathan D Guest, Hong Ji, Anna Kushnir and 11 more

Erratum issued 2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nature communications, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 45 papers.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed
14.2field-weighted citation impact, top 1% 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.

NCT02878330 phase2completednot on this map

A Phase 2b Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants

TypeinterventionalSponsorMedImmune LLCRan2016 to 2018Enrolled1,453ConditionsRespiratory Syncytial Virus InfectionsArmsMEDI8897, Placebo
NCT03979313 phase3completednot on this map

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY)

TypeinterventionalSponsorAstraZenecaRan2019 to 2023Enrolled3,012ConditionsRespiratory Syncytial Virus InfectionsArmsMEDI8897, Placebo
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 66 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 7 institutions in 5 countries.

Bahar Ahani *Bioinformatics, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Kevin M Tuffy *Translational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Anastasia A AksyukTranslational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.ORCID http://orcid.org/0000-0001-9778-3491
Deidre WilkinsTranslational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Michael E AbramTranslational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.ORCID http://orcid.org/0000-0002-6505-7281
Ron DaganThe Shraga Segal Department of Microbiology, Immunology and Genetics, Faculty of Health Sciences of the Ben-Gurion University of the Negev, Beer-Sheva, Israel.ORCID http://orcid.org/0000-0002-8888-1046
Joseph B DomachowskeState University of New York Upstate Medical University, Syracuse, NY, USA.
Johnathan D GuestVirology and Vaccine Discovery, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.ORCID http://orcid.org/0000-0003-1521-5242
Hong JiTranslational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Anna KushnirTranslational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Amanda LeachClinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Shabir A MadhiSouth African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.ORCID http://orcid.org/0000-0002-7629-0636
Vaishali S MankadClinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Durham, NC, USA.
Eric A F SimõesUniversity of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO, USA.
Benjamin SparklinBioinformatics, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.ORCID http://orcid.org/0000-0002-5547-185X
Scott D SpeerTranslational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Ann Marie StanleyTranslational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.ORCID http://orcid.org/0000-0002-0588-8681
David E TaborTranslational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Ulrika Wählby HamrénClinical Pharmacology and Quantitative Pharmacology, R&D, AstraZeneca, Gothenburg, Sweden.
Elizabeth J KellyTranslational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA. beth.kelly@astrazeneca.com.ORCID http://orcid.org/0000-0002-6988-8576
Tonya VillafanaClinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
AstraZeneca (United States) · USAstraZeneca (France) · FRAstraZeneca (Sweden) · SEBen-Gurion University of the Negev · ILChildren's Hospital Colorado · USSouth African Medical Research Council · ZASUNY Upstate Medical University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Nirsevimab is a monoclonal antibody that binds to the respiratory syncytial virus (RSV) fusion protein. During the Phase 2b (NCT02878330) and MELODY (NCT03979313) clinical trials, infants received one dose of nirsevimab or placebo before their first RSV season. In this pre-specified analysis, isolates from RSV infections were subtyped, sequenced and analyzed for nirsevimab binding site substitutions; subsequently, recombinant RSVs were engineered for microneutralization susceptibility testing. Here we show that the frequency of infections caused by subtypes A and B is similar across and within the two trials. In addition, RSV A had one and RSV B had 10 fusion protein substitutions occurring at >5% frequency. Notably, RSV B binding site substitutions were rare, except for the highly prevalent I206M:Q209R, which increases nirsevimab susceptibility; RSV B isolates from two participants had binding site substitutions that reduce nirsevimab susceptibility. Overall, >99% of isolates from the Phase 2b and MELODY trials retained susceptibility to nirsevimab.

Indexed as

Respiratory Syncytial Virus, HumanRespiratory Syncytial Virus InfectionsAntibodies, Monoclonal, HumanizedHumansInfantRecombinant ProteinsAntibodies, Monoclonal, HumanizednirsevimabRecombinant Proteins

Identifiers

PMID37468530
PMCPMC10356750
OpenAlexW4384818832

What OpenQuestion holds

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LicenceCC BY
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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.