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.

Autor:	Stuart ASV; Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, United Kingdom., Virta M; Tampere University, Tampere, Finland., Williams K; Janssen Vaccines & Prevention BV, Leiden, The Netherlands., Seppa I; Tampere University, Tampere, Finland., Hartvickson R; Axtell Clinic, Newton, Kansas, USA., Greenland M; Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, United Kingdom., Omoruyi E; Janssen Infectious Diseases, Beerse, Belgium., Bastian AR; Janssen Vaccines & Prevention BV, Leiden, The Netherlands., Haazen W; Janssen Vaccines & Prevention BV, Leiden, The Netherlands., Salisch N; Janssen Vaccines & Prevention BV, Leiden, The Netherlands., Gymnopoulou E; Janssen Infectious Diseases, Beerse, Belgium., Callendret B; Janssen Vaccines & Prevention BV, Leiden, The Netherlands., Faust SN; NIHR Southampton Clinical Research Facility and NIHR Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom.; Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, United Kingdom., Snape MD; Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, United Kingdom.; Oxford NIHR - Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom., Heijnen E; Janssen Vaccines & Prevention BV, Leiden, The Netherlands.
Jazyk:	angličtina
Zdroj:	The Journal of infectious diseases [J Infect Dis] 2022 Dec 28; Vol. 227 (1), pp. 71-82.
DOI:	10.1093/infdis/jiac407
Abstrakt:	Background: Respiratory 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. Methods: In 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. Results: In 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%). Conclusions: Ad26.RSV.preF demonstrated immunogenicity in healthy adults and toddlers, with no safety concerns raised. Evaluations in RSV-seronegative children are underway. Competing Interests: Potential conflicts of interest. M. D. S. was an NIHR Senior Investigator and receives salary support from the Oxford NIHR Biomedical Research Centre when undertaking this work. S. N. F. is an NIHR Senior Investigator and receives salary support from the NIHR Southampton Clinical Research Facility and Biomedical Research Centre. K. W., A. R. B., W. H., N. S., E. G., E. O., and B. C., and E. H. are employees of Janssen and may be Johnson & Johnson stockholders. M. D. S. received research grants (through The University of Oxford) from the following: GlaxoSmithKline, Pfizer, Janssen, MCM vaccines, MedImmune, and AstraZeneca, vaccine from Novavax for COVID-19 vaccine studies. He received no personal payment for this work. MDS was a member of medical advisory boards for the Meningitis Research Foundation. From September 2022 MDS is employed by Moderna Biotech UK; this work was completed prior to this employment. S. N. F. received research grants (through University Hospital Southampton) from the following: Johnson & Johnson, Pfizer, Sanofi, GlaxoSmithKline, Merck, AstraZeneca, and Valneva; honoraria from Johnson & Johnson and Pfizer; he has been an advisor for AstraZeneca, MedImmune, Sanofi, Pfizer, Seqirus, Merck, Johnson & Johnson, and GlaxoSmithKline (but received no personal payments for this work, all honoraria were paid to University Hospital Southampton NHS Foundation Trust); and he acted as a paid chair of UK NICE Sepsis and Lyme Disease Guidelines. I. S. received expenses from Janssen to cover travel to an investigator meeting. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed. (© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
Databáze:	MEDLINE
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