PMID- 36259542
OWN - NLM
STAT- MEDLINE
DCOM- 20221230
LR  - 20230328
IS  - 1537-6613 (Electronic)
IS  - 0022-1899 (Print)
IS  - 0022-1899 (Linking)
VI  - 227
IP  - 1
DP  - 2022 Dec 28
TI  - 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.
PG  - 71-82
LID - 10.1093/infdis/jiac407 [doi]
AB  - 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 x 1011 viral particles [vp] for adults, 5 x 
      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.
CI  - (c) The Author(s) 2022. Published by Oxford University Press on behalf of 
      Infectious Diseases Society of America.
FAU - Stuart, Arabella S V
AU  - Stuart ASV
AD  - Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, 
      United Kingdom.
FAU - Virta, Miia
AU  - Virta M
AD  - Tampere University, Tampere, Finland.
FAU - Williams, Kristi
AU  - Williams K
AD  - Janssen Vaccines & Prevention BV, Leiden, The Netherlands.
FAU - Seppa, Ilkka
AU  - Seppa I
AD  - Tampere University, Tampere, Finland.
FAU - Hartvickson, Robyn
AU  - Hartvickson R
AD  - Axtell Clinic, Newton, Kansas, USA.
FAU - Greenland, Melanie
AU  - Greenland M
AD  - Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, 
      United Kingdom.
FAU - Omoruyi, Edmund
AU  - Omoruyi E
AD  - Janssen Infectious Diseases, Beerse, Belgium.
FAU - Bastian, Arangassery Rosemary
AU  - Bastian AR
AD  - Janssen Vaccines & Prevention BV, Leiden, The Netherlands.
FAU - Haazen, Wouter
AU  - Haazen W
AD  - Janssen Vaccines & Prevention BV, Leiden, The Netherlands.
FAU - Salisch, Nadine
AU  - Salisch N
AD  - Janssen Vaccines & Prevention BV, Leiden, The Netherlands.
FAU - Gymnopoulou, Efi
AU  - Gymnopoulou E
AD  - Janssen Infectious Diseases, Beerse, Belgium.
FAU - Callendret, Benoit
AU  - Callendret B
AD  - Janssen Vaccines & Prevention BV, Leiden, The Netherlands.
FAU - Faust, Saul N
AU  - Faust SN
AD  - NIHR Southampton Clinical Research Facility and NIHR Biomedical Research Centre, 
      University Hospital Southampton NHS Foundation Trust, Southampton, United 
      Kingdom.
AD  - Faculty of Medicine and Institute for Life Sciences, University of Southampton, 
      Southampton, United Kingdom.
FAU - Snape, Matthew D
AU  - Snape MD
AD  - Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, 
      United Kingdom.
AD  - Oxford NIHR - Biomedical Research Centre, Oxford University Hospitals NHS 
      Foundation Trust, Oxford, United Kingdom.
FAU - Heijnen, Esther
AU  - Heijnen E
AD  - Janssen Vaccines & Prevention BV, Leiden, The Netherlands.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Infect Dis
JT  - The Journal of infectious diseases
JID - 0413675
RN  - 0 (Respiratory Syncytial Virus Vaccines)
RN  - 0 (Antibodies, Neutralizing)
RN  - 0 (Antibodies, Viral)
SB  - IM
MH  - Humans
MH  - Adult
MH  - Child
MH  - *Respiratory Syncytial Virus Infections
MH  - *Respiratory Syncytial Virus Vaccines
MH  - Antibodies, Neutralizing
MH  - Antibodies, Viral
MH  - *Respiratory Syncytial Virus, Human/genetics
MH  - Adenoviridae/genetics
MH  - Immunogenicity, Vaccine
PMC - PMC9796164
OTO - NOTNLM
OT  - adenovirus vectors
OT  - pediatric
OT  - respiratory syncytial virus
OT  - seropositive
OT  - vaccine
COIS- 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.
EDAT- 2022/10/20 06:00
MHDA- 2022/12/31 06:00
PMCR- 2022/10/19
CRDT- 2022/10/19 07:02
PHST- 2022/04/20 00:00 [received]
PHST- 2022/10/17 00:00 [accepted]
PHST- 2022/10/20 06:00 [pubmed]
PHST- 2022/12/31 06:00 [medline]
PHST- 2022/10/19 07:02 [entrez]
PHST- 2022/10/19 00:00 [pmc-release]
AID - 6763323 [pii]
AID - jiac407 [pii]
AID - 10.1093/infdis/jiac407 [doi]
PST - ppublish
SO  - J Infect Dis. 2022 Dec 28;227(1):71-82. doi: 10.1093/infdis/jiac407.