Intranasal parainfluenza virus type 5 (PIV5)-vectored RSV vaccine is safe and immunogenic in healthy adults in a phase 1 clinical study.
Sci Adv
; 9(43): eadj7611, 2023 10 27.
Article
em En
| MEDLINE
| ID: mdl-37878713
ABSTRACT
Respiratory syncytial virus (RSV) can lead to serious disease in infants, and no approved RSV vaccine is available for infants. This first in-human clinical trial evaluated a single dose of BLB201, a PIV5-vectored RSV vaccine administrated via intranasal route, for safety and immunogenicity in RSV-seropositive healthy adults (33 to 75 years old). No severe adverse events (SAEs) were reported. Solicited local and systemic AEs were reported by <50% of participants and were mostly mild in intensity. Vaccine virus shedding was detected in 17% of participants. Nasal RSV-specific immunoglobulin A responses were detected in 48%, the highest level observed in adults among all intranasal RSV vaccines evaluated in humans. RSV-neutralizing antibodies titers in serum rose ≥1.5-fold. Peripheral blood RSV F-specific CD4+ and CD8+ T cells increased from ≤0.06% at baseline to ≥0.26 and 0.4% after vaccination, respectively, in >93% participants. The safety and immunogenicity profile of BLB201 in RSV-seropositive adults supports the further clinical development of BLB201.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Vírus Sincicial Respiratório Humano
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Infecções por Vírus Respiratório Sincicial
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Vacinas contra Vírus Sincicial Respiratório
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Vírus da Parainfluenza 5
Limite:
Adult
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Aged
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Humans
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Middle aged
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article