Evidence map›Paper›PMID 36259542›Full record

Trial reportThe Journal of infectious diseases2022

Phase 1/2a Safety and Immunogenicity of an Adenovirus 26 Vector Respiratory Syncytial Virus (RSV) Vaccine Encoding Prefusion F in Adults 18-50 Years and RSV-Seropositive Children 12-24 Months.

Arabella S V Stuart, Miia Virta, Kristi Williams, Ilkka Seppa, Robyn Hartvickson, Melanie Greenland, Edmund Omoruyi, Arangassery Rosemary Bastian, Wouter Haazen, Nadine Salisch and 5 more

Abstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Full text at PMC Publisher
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. Cited by 27 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Review
  6. Review
  7. Article
  8. Developing the next-generation of adenoviral vector vaccines.Human vaccines & immunotherapeutics · 2025
    Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Article
  15. Review
  16. Analysis of BeyfortusCurrent issues in molecular biology · 2024
    Review
  17. Article
  18. Article
  19. Review
  20. Article
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

15 authors.

Arabella S V StuartOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, United Kingdom.
Miia VirtaTampere University, Tampere, Finland.
Kristi WilliamsJanssen Vaccines & Prevention BV, Leiden, The Netherlands.
Ilkka SeppaTampere University, Tampere, Finland.
Robyn HartvicksonAxtell Clinic, Newton, Kansas, USA.
Melanie GreenlandOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, United Kingdom.
Edmund OmoruyiJanssen Infectious Diseases, Beerse, Belgium.
Arangassery Rosemary BastianJanssen Vaccines & Prevention BV, Leiden, The Netherlands.
Wouter HaazenJanssen Vaccines & Prevention BV, Leiden, The Netherlands.
Nadine SalischJanssen Vaccines & Prevention BV, Leiden, The Netherlands.
Efi GymnopoulouJanssen Infectious Diseases, Beerse, Belgium.
Benoit CallendretJanssen Vaccines & Prevention BV, Leiden, The Netherlands.
Saul N FaustNIHR Southampton Clinical Research Facility and NIHR Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom.
Matthew D SnapeOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, United Kingdom.
Esther HeijnenJanssen Vaccines & Prevention BV, Leiden, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRespiratory syncytial virus (RSV) remains a leading cause of pediatric morbidity, with no approved vaccine. We assessed the safety and immunogenicity of the Ad26.RSV.preF vaccine candidate in adults and children.

methodsIn this randomized, double-blind, phase 1/2a, placebo-controlled study, 12 adults (18-50 years) and 36 RSV-seropositive children (12-24 months) were randomized 2:1 to Ad26.RSV.preF (1 × 1011 viral particles [vp] for adults, 5 × 1010 vp for children) or placebo, at day 1 and 29, with 6-month immunogenicity and 1-year safety follow-up. Respiratory syncytial virus infection was an exploratory outcome in children.

resultsIn adults, solicited adverse events (AEs) were generally mild to moderate, with no serious AEs. In children, no vaccination-related serious AEs were reported; fever was reported in 14 (58.3%) Ad26.RSV.preF recipients. Baseline pediatric geometric mean titers for RSV A2 neutralization increased from 121 (95% confidence interval [CI], 76-191) to 1608 (95% CI, 730-3544) at day 29, and 2235 (95% CI, 1586-3150) at day 57, remaining elevated over 7 months. Respiratory syncytial virus infection was confirmed in fewer children receiving Ad26.RSV.preF (1, 4.2%) than placebo (5, 41.7%).

conclusionsAd26.RSV.preF demonstrated immunogenicity in healthy adults and toddlers, with no safety concerns raised. Evaluations in RSV-seronegative children are underway.

Indexed as

Respiratory Syncytial Virus, HumanRespiratory Syncytial Virus InfectionsRespiratory Syncytial Virus VaccinesAdenoviridaeAdultAntibodies, NeutralizingAntibodies, ViralChildHumansImmunogenicity, VaccineAntibodies, NeutralizingAntibodies, ViralRespiratory Syncytial Virus Vaccinesadenovirus vectorspediatricrespiratory syncytial virusseropositivevaccine

Identifiers

PMID36259542
PMCPMC9796164

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.