Phase 1/2 clinical trial of COVID-19 vaccine in Japanese participants: A report of interim findings.
Vaccine
; 40(27): 3721-3726, 2022 06 15.
Article
en En
| MEDLINE
| ID: mdl-35606235
ABSTRACT
We initiated a randomized, placebo-controlled, phase 1/2 trial to evaluate the safety and immunogenicity of the S-268019-b recombinant protein vaccine, scheduled as 2 intramuscular injections given 21 days apart, in 60 randomized healthy Japanese adults. We evaluated 2 regimens of the S-910823 antigen (5 µg [n = 24] and 10 µg [n = 24]) with an oil-in-water emulsion formulation and compared against placebo (n = 12). Reactogenicity was mild in most participants. No serious adverse events were noted. For both regimens, vaccination resulted in robust IgG and neutralizing antibody production at days 36 and 50 and predominant T-helper 1-mediated immune reaction, as evident through antigen-specific polyfunctional CD4+ T-cell responses with IFN-γ, IL-2, and IL-4 production on spike protein peptides stimulation. Based on the interim analysis, the S-268019-b vaccine is safe, produces neutralizing antibodies titer comparable with that in convalescent serum from COVID-19-recovered patients. However, further evaluation of the vaccine in a large clinical trial is warranted.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Vacunas contra la COVID-19
/
COVID-19
Tipo de estudio:
Clinical_trials
/
Diagnostic_studies
Límite:
Adult
/
Humans
País/Región como asunto:
Asia
Idioma:
En
Revista:
Vaccine
Año:
2022
Tipo del documento:
Article
País de afiliación:
Japón