| Full text | |
| Author(s): Show less - |
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
Total Authors: 15
|
| Document type: | Journal article |
| Source: | Nanomedicine; v. 18, n. 18, p. 20-pg., 2023-09-15. |
| Abstract | |
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) | |
| FAPESP's process: | 20/05527-0 - Bivalent intranasal vaccine using influenza virus expressing SARS-CoV-2 protein S (spike): protection mechanisms and lung injury |
| Grantee: | Ricardo Tostes Gazzinelli |
| Support Opportunities: | Regular Research Grants |