| Texto completo | |
| Autor(es): Mostrar menos - |
Assis, Bruna Rodrigues Dias
;
Gomes, Isabela Pereira
;
de Castro, Julia Teixeira
;
Rivelli, Graziella Gomes
;
de Castro, Natalia Salazar
;
Gomez-Mendoza, Diana Paola
;
Bagno, Flavia Fonseca
;
Hojo-Souza, Natalia Satchiko
;
Maia, Ana Luiza Chaves
;
Lages, Eduardo Burgarelli
;
da Fonseca, Flavio Guimaraes
;
Teixeira, Santuza Maria Ribeiro
;
Fernandes, Ana Paula
;
Gazzinelli, Ricardo Tostes
;
Goulart, Gisele Assis Castro
Número total de Autores: 15
|
| Tipo de documento: | Artigo Científico |
| Fonte: | Nanomedicine; v. 18, n. 18, p. 20-pg., 2023-09-15. |
| Resumo | |
Aim: To develop, characterize and evaluate an oil/water nanoemulsion with squalene (CTVad1) to be approved as an adjuvant for the SpiN COVID-19 vaccine clinical trials. Materials & methods: Critical process parameters (CPPs) of CTVad1 were standardized to meet the critical quality attributes (CQAs) of an adjuvant for human use. CTVad1 and the SpiN-CTVad1 vaccine were submitted to physicochemical, stability, in vitro and in vivo studies. Results & conclusion: All CQAs were met in the CTVad1 production process. SpiN- CTVad1 met CQAs and induced high levels of antibodies and specific cellular responses in in vivo studies. These results represented a critical step in the process developed to meet regulatory requirements for the SpiN COVID-19 vaccine clinical trial. (AU) | |
| Processo FAPESP: | 20/05527-0 - Vacina intranasal bivalente utilizando vírus influenza expressando a proteína S (spike) do SARS-CoV-2: mecanismos de proteção e lesão pulmonar |
| Beneficiário: | Ricardo Tostes Gazzinelli |
| Modalidade de apoio: | Auxílio à Pesquisa - Regular |