Evidence map›Paper›PMID 32897368›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2021

Suptavumab for the Prevention of Medically Attended Respiratory Syncytial Virus Infection in Preterm Infants.

Eric A F Simões, Eduardo Forleo-Neto, Gregory P Geba, Mohamed Kamal, Feng Yang, Helen Cicirello, Matthew R Houghton, Ronald Rideman, Qiong Zhao, Sarah L Benvin and 13 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02325791 (A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of a Human Monoclonal Antibody, REGN2222, for the Prevention of Medically Attended RSV Infection in Preterm Infants), which is not on this map. Cited by 99 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
99citing papers in PubMed, 6 pooled it
11.3field-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.

NCT02325791 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of a Human Monoclonal Antibody, REGN2222, for the Prevention of Medically Attended RSV Infection in Preterm Infants

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2015 to 2017Enrolled1,177ConditionsRespiratory Syncytial Virus InfectionsArmsSuptavumab 30 mg/kg, Placebo Matched to Suptavumab, Suptavumab 30 mg/kg- 1 Dose, Suptavumab 30 mg/kg - 2 Doses
3 · Its place in the literature

Who cites it

99 citing papers in PubMed, 6 syntheses or guidelines pooled it, 145 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Review
  13. Article
  14. Review
  15. Detection of nirsevimab-resistant RSV-B variants in children carrying the F:N201T substitution through genomic surveillance, Spain, 2025/26 season.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2026
    Article
  16. Article
  17. Review
  18. Review
  19. Review
  20. Review

39 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors at 5 institutions in 2 countries.

Eric A F SimõesDepartment of Pediatrics, University of Colorado School of Medicine, and The Children's Hospital Colorado, Aurora, Colorado, USA.
Eduardo Forleo-NetoRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Gregory P GebaRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Mohamed KamalRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Feng YangRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Helen CicirelloRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Matthew R HoughtonRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Ronald RidemanRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Qiong ZhaoRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Sarah L BenvinRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Alicia HawesRegeneron Genetics Center, Tarrytown, New York, USA.
Erin D FullerRegeneron Genetics Center, Tarrytown, New York, USA.
Elzbieta WlogaRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Jose M Novoa PizarroFacultad Medicina Universidad del Desarrollo/CAS, Hospital Padre Hurtado, Santiago, Chile.
Flor M MunozDepartment of Pediatrics, Baylor College of Medicine, Houston, Texas, USA.
Scott A RushDepartment of Molecular Biosciences, University of Texas at Austin, Austin, Texas, USA.
Jason S McLellanDepartment of Molecular Biosciences, University of Texas at Austin, Austin, Texas, USA.
Leah LipsichRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Neil StahlRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
George D YancopoulosRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
David M WeinreichRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Christos A KyratsousRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Sumathi SivapalasingamRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Regeneron (United States) · USThe University of Texas at Austin · USBaylor College of Medicine · USUniversidad del Desarrollo · CLUniversity of Colorado Denver · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRespiratory syncytial virus (RSV) is a major cause of childhood medically attended respiratory infection (MARI).

methodsWe conducted a randomized, double-blind, placebo-controlled phase 3 trial in 1154 preterm infants of 1 or 2 doses of suptavumab, a human monoclonal antibody that can bind and block a conserved epitope on RSV A and B subtypes, for the prevention of RSV MARI. The primary endpoint was proportion of subjects with RSV-confirmed hospitalizations or outpatient lower respiratory tract infection (LRTI).

resultsThere were no significant differences between primary endpoint rates (8.1%, placebo; 7.7%, 1-dose; 9.3%, 2-dose). Suptavumab prevented RSV A infections (relative risks, .38; 95% confidence interval [CI], .14-1.05 in the 1-dose group and .39 [95% CI, .14-1.07] in the 2-dose group; nominal significance of combined suptavumab group vs placebo; P = .0499), while increasing the rate of RSV B infections (relative risk 1.36 [95% CI, .73-2.56] in the 1-dose group and 1.69 [95% CI, .92-3.08] in the 2-dose group; nominal significance of combined suptavumab group vs placebo; P = .12). Sequenced RSV isolates demonstrated no suptavumab epitope changes in RSV A isolates, while all RSV B isolates had 2-amino acid substitution in the suptavumab epitope that led to loss of neutralization activity. Treatment emergent adverse events were balanced across treatment groups.

conclusionsSuptavumab did not reduce overall RSV hospitalizations or outpatient LRTI because of a newly circulating mutant strain of RSV B. Genetic variation in circulating RSV strains will continue to challenge prevention efforts. CLINICAL TRIALS REGISTRATION: NCT02325791.

Indexed as

Respiratory Syncytial Virus, HumanRespiratory Syncytial Virus InfectionsAntibodies, MonoclonalAntiviral AgentsHumansInfantInfant, NewbornInfant, PrematureAntibodies, MonoclonalAntiviral Agentsefficacyinfantsrespiratory syncytial virussafety

Identifiers

PMID32897368
PMCPMC8653633
OpenAlexW3084204945

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.