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Safety and immunogenicity of a ChAd155-vectored respiratory syncytial virus vaccine in infants 6–7 months of age: a phase 1/2 randomized trial

Safety and immunogenicity of a ChAd155-vectored respiratory syncytial virus vaccine in infants 6–7 months of age: a phase 1/2 randomized trial
Safety and immunogenicity of a ChAd155-vectored respiratory syncytial virus vaccine in infants 6–7 months of age: a phase 1/2 randomized trial
Background: respiratory syncytial virus (RSV) is a common cause of lower respiratory tract infections in infants. This phase 1/2, observer-blind, randomized, controlled study assessed the safety and immunogenicity of an investigational chimpanzee-derived adenoviral vector RSV vaccine (ChAd155-RSV, expressing RSV F, N, and M2-1) in infants.

Methods: healthy 6- to 7-month-olds were 1:1:1-randomized to receive 1 low ChAd155-RSV dose (1.5 × 1010 viral particles) followed by placebo (RSV_1D); 2 high ChAd155-RSV doses (5 × 1010 viral particles) (RSV_2D); or active comparator vaccines/placebo (comparator) on days 1 and 31. Follow-up lasted approximately 2 years.

Results: two hundred one infants were vaccinated (RSV_1D: 65; RSV_2D: 71; comparator: 65); 159 were RSV-seronaive at baseline. Most solicited and unsolicited adverse events after ChAd155-RSV occurred at similar or lower rates than after active comparators. In infants who developed RSV infection, there was no evidence of vaccine-associated enhanced respiratory disease (VAERD). RSV-A neutralizing titers and RSV F-binding antibody concentrations were higher post–ChAd155-RSV than postcomparator at days 31, 61, and end of RSV season 1 (mean follow-up, 7 months). High-dose ChAd155-RSV induced stronger responses than low-dose, with further increases post–dose 2.

Conclusions: ChAd155-RSV administered to 6- to 7-month-olds had a reactogenicity/safety profile like other childhood vaccines, showed no evidence of VAERD, and induced a humoral immune response.

Clinical trials registration: NCT03636906.
Antibodies, Neutralizing, Antibodies, Viral, Child, Genetic Vectors, Humans, Immunogenicity, Vaccine, Infant, Respiratory Syncytial Virus Infections/prevention & control, Respiratory Syncytial Virus Vaccines, Respiratory Syncytial Virus, Human/genetics, infant, immunogenicity, ChAd155, RSV, vaccine-associated enhanced respiratory disease
0022-1899
95-107
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Kuchar, Ernest
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Pinto, Jorge
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Puthanakit, Thanyawee
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Castelli Gattinara, Guido
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Campbell, James D.
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Faust, Saul N.
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Zhou, Yingjun
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Pu, Wenji
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Mcphee, Roderick
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Stoszek, Sonia K.
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Vanhoutte, Nicolas
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Sáez-llorens, Xavier
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Luciani, Kathia
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Epalza, Cristina
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Cetin, Benhur S.
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De Leon, Tirza
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Anderson, Evan J.
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Zhou, Yingjun
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Pu, Wenji
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Friel, Damien
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Mcphee, Roderick
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Stoszek, Sonia K.
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Sáez-llorens, Xavier, Norero, Ximena, Mussi-pinhata, Marisa Márcia, Luciani, Kathia, Salamanca De La Cueva, Ignacio, Díez-domingo, Javier, Lopez-medina, Eduardo, Epalza, Cristina, Brzostek, Jerzy, Szymański, Henryk, Boucher, François D., Cetin, Benhur S., De Leon, Tirza, Cagri Dinleyici, Ener, Marín Gabriel, Miguel Ángel, Ince, Tolga, Macias-parra, Mercedes, Langley, Joanne M., Martinón-torres, Federico, Rämet, Mika, Kuchar, Ernest, Pinto, Jorge, Puthanakit, Thanyawee, Baquero-artigao, Fernando, Castelli Gattinara, Guido, Merino Arribas, Jose Manuel, Ramos Amador, Jose Tomas, Szenborn, Leszek, Tapiero, Bruce, Anderson, Evan J., Campbell, James D., Faust, Saul N., Nikic, Vanja, Zhou, Yingjun, Pu, Wenji, Friel, Damien, Dieussaert, Ilse, Gonzalez Lopez, Antonio, Mcphee, Roderick, Stoszek, Sonia K. and Vanhoutte, Nicolas (2024) Safety and immunogenicity of a ChAd155-vectored respiratory syncytial virus vaccine in infants 6–7 months of age: a phase 1/2 randomized trial. The Journal of Infectious Diseases, 229 (1), 95-107, [jiad271]. (doi:10.1093/infdis/jiad271).

Record type: Article

Abstract

Background: respiratory syncytial virus (RSV) is a common cause of lower respiratory tract infections in infants. This phase 1/2, observer-blind, randomized, controlled study assessed the safety and immunogenicity of an investigational chimpanzee-derived adenoviral vector RSV vaccine (ChAd155-RSV, expressing RSV F, N, and M2-1) in infants.

Methods: healthy 6- to 7-month-olds were 1:1:1-randomized to receive 1 low ChAd155-RSV dose (1.5 × 1010 viral particles) followed by placebo (RSV_1D); 2 high ChAd155-RSV doses (5 × 1010 viral particles) (RSV_2D); or active comparator vaccines/placebo (comparator) on days 1 and 31. Follow-up lasted approximately 2 years.

Results: two hundred one infants were vaccinated (RSV_1D: 65; RSV_2D: 71; comparator: 65); 159 were RSV-seronaive at baseline. Most solicited and unsolicited adverse events after ChAd155-RSV occurred at similar or lower rates than after active comparators. In infants who developed RSV infection, there was no evidence of vaccine-associated enhanced respiratory disease (VAERD). RSV-A neutralizing titers and RSV F-binding antibody concentrations were higher post–ChAd155-RSV than postcomparator at days 31, 61, and end of RSV season 1 (mean follow-up, 7 months). High-dose ChAd155-RSV induced stronger responses than low-dose, with further increases post–dose 2.

Conclusions: ChAd155-RSV administered to 6- to 7-month-olds had a reactogenicity/safety profile like other childhood vaccines, showed no evidence of VAERD, and induced a humoral immune response.

Clinical trials registration: NCT03636906.

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Accepted/In Press date: 20 July 2023
e-pub ahead of print date: 21 July 2023
Published date: 15 January 2024
Additional Information: Funding Information: Financial support. This work was supported by GlaxoSmithKline Biologicals SA.
Keywords: Antibodies, Neutralizing, Antibodies, Viral, Child, Genetic Vectors, Humans, Immunogenicity, Vaccine, Infant, Respiratory Syncytial Virus Infections/prevention & control, Respiratory Syncytial Virus Vaccines, Respiratory Syncytial Virus, Human/genetics, infant, immunogenicity, ChAd155, RSV, vaccine-associated enhanced respiratory disease

Identifiers

Local EPrints ID: 480998
URI: http://eprints.soton.ac.uk/id/eprint/480998
DOI: doi:10.1093/infdis/jiad271
ISSN: 0022-1899
PURE UUID: 7f16b904-0f43-4f90-9718-9cd67ad165cf
ORCID for Saul N. Faust: ORCID iD orcid.org/0000-0003-3410-7642

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Date deposited: 14 Aug 2023 16:56
Last modified: 18 Mar 2024 03:04

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Contributors

Author: Xavier Sáez-llorens
Author: Ximena Norero
Author: Marisa Márcia Mussi-pinhata
Author: Kathia Luciani
Author: Ignacio Salamanca De La Cueva
Author: Javier Díez-domingo
Author: Eduardo Lopez-medina
Author: Cristina Epalza
Author: Jerzy Brzostek
Author: Henryk Szymański
Author: François D. Boucher
Author: Benhur S. Cetin
Author: Tirza De Leon
Author: Ener Cagri Dinleyici
Author: Miguel Ángel Marín Gabriel
Author: Tolga Ince
Author: Mercedes Macias-parra
Author: Joanne M. Langley
Author: Federico Martinón-torres
Author: Mika Rämet
Author: Ernest Kuchar
Author: Jorge Pinto
Author: Thanyawee Puthanakit
Author: Fernando Baquero-artigao
Author: Guido Castelli Gattinara
Author: Jose Manuel Merino Arribas
Author: Jose Tomas Ramos Amador
Author: Leszek Szenborn
Author: Bruce Tapiero
Author: Evan J. Anderson
Author: James D. Campbell
Author: Saul N. Faust ORCID iD
Author: Vanja Nikic
Author: Yingjun Zhou
Author: Wenji Pu
Author: Damien Friel
Author: Ilse Dieussaert
Author: Antonio Gonzalez Lopez
Author: Roderick Mcphee
Author: Sonia K. Stoszek
Author: Nicolas Vanhoutte

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