The University of Southampton
University of Southampton Institutional Repository

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

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
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

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.

adenovirus vectors, pediatric, respiratory syncytial virus, seropositive, vaccine
0022-1899
71-82
Stuart, Arabella S.V.
33deeaa1-85ee-45fd-8074-2f63012b6f8d
Virta, Miia
2cb714b1-583d-41c8-b5c9-8c841ca4b6fd
Williams, Kristi
2afa0ffe-019f-4f4b-b7a3-59c29f6ee2da
Seppa, Ilkka
79170565-6746-4313-a850-f45b20cd5db4
Hartvickson, Robyn
1a89f949-54f0-4d60-a9e3-9cf828696c05
Greenland, Melanie
f1ad44ed-4d20-4800-9d91-89a103a46182
Omoruyi, Edmund
13899621-5e8d-41b1-87d1-6c928ce6813f
Bastian, Arangassery Rosemary
3b864655-caf4-40f4-8edb-ed80c1a4e84f
Haazen, Wouter
8e522625-3a08-400c-8b19-e8b67bbfeed9
Salisch, Nadine
36c04223-d08b-4523-91b9-f21c2f4f3425
Gymnopoulou, Efi
81c0f04e-d2e4-4c45-b046-ceb9fe5a2ed2
Callendret, Benoit
eff00588-d9e4-4bd1-9dcb-7d4d5c47f72d
Faust, Saul N
f97df780-9f9b-418e-b349-7adf63e150c1
Snape, Matthew D
184fac36-63b2-40d2-be21-c972f41d07ab
Heijnen, Esther
c539b251-bb4c-449a-a2e5-e645c034c80f
Stuart, Arabella S.V.
33deeaa1-85ee-45fd-8074-2f63012b6f8d
Virta, Miia
2cb714b1-583d-41c8-b5c9-8c841ca4b6fd
Williams, Kristi
2afa0ffe-019f-4f4b-b7a3-59c29f6ee2da
Seppa, Ilkka
79170565-6746-4313-a850-f45b20cd5db4
Hartvickson, Robyn
1a89f949-54f0-4d60-a9e3-9cf828696c05
Greenland, Melanie
f1ad44ed-4d20-4800-9d91-89a103a46182
Omoruyi, Edmund
13899621-5e8d-41b1-87d1-6c928ce6813f
Bastian, Arangassery Rosemary
3b864655-caf4-40f4-8edb-ed80c1a4e84f
Haazen, Wouter
8e522625-3a08-400c-8b19-e8b67bbfeed9
Salisch, Nadine
36c04223-d08b-4523-91b9-f21c2f4f3425
Gymnopoulou, Efi
81c0f04e-d2e4-4c45-b046-ceb9fe5a2ed2
Callendret, Benoit
eff00588-d9e4-4bd1-9dcb-7d4d5c47f72d
Faust, Saul N
f97df780-9f9b-418e-b349-7adf63e150c1
Snape, Matthew D
184fac36-63b2-40d2-be21-c972f41d07ab
Heijnen, Esther
c539b251-bb4c-449a-a2e5-e645c034c80f

Stuart, Arabella S.V., Virta, Miia, Williams, Kristi, Seppa, Ilkka, Hartvickson, Robyn, Greenland, Melanie, Omoruyi, Edmund, Bastian, Arangassery Rosemary, Haazen, Wouter, Salisch, Nadine, Gymnopoulou, Efi, Callendret, Benoit, Faust, Saul N, Snape, Matthew D and Heijnen, Esther (2022) 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. The Journal of Infectious Diseases, 227 (1), 71-82. (doi:10.1093/infdis/jiac407).

Record type: Article

Abstract

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.

Text
jiac407 - Version of Record
Download (630kB)

More information

Accepted/In Press date: 17 October 2022
e-pub ahead of print date: 19 October 2022
Published date: 28 December 2022
Additional Information: Publisher Copyright: © The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America.
Keywords: adenovirus vectors, pediatric, respiratory syncytial virus, seropositive, vaccine

Identifiers

Local EPrints ID: 473157
URI: http://eprints.soton.ac.uk/id/eprint/473157
ISSN: 0022-1899
PURE UUID: 23cbc9da-02bd-45ad-9973-4edfa76180b8
ORCID for Saul N Faust: ORCID iD orcid.org/0000-0003-3410-7642

Catalogue record

Date deposited: 11 Jan 2023 17:30
Last modified: 17 Mar 2024 03:06

Export record

Altmetrics

Contributors

Author: Arabella S.V. Stuart
Author: Miia Virta
Author: Kristi Williams
Author: Ilkka Seppa
Author: Robyn Hartvickson
Author: Melanie Greenland
Author: Edmund Omoruyi
Author: Arangassery Rosemary Bastian
Author: Wouter Haazen
Author: Nadine Salisch
Author: Efi Gymnopoulou
Author: Benoit Callendret
Author: Saul N Faust ORCID iD
Author: Matthew D Snape
Author: Esther Heijnen

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of http://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×