Quality Attributes of Ctvad1, A Nanoemulsified Adjuvant for Phase I Clinical Trial of SpiN COVID-19 Vaccine

• DOI: 10.2217/nnm-2023-0122
• Publication Date: 2023-09-15T12:05:11Z
• Authors: Bruna Rodrigues D...; Isabela Pereira G...; Júlia Teixeira de...; Graziella Gomes R...; Natália Salazar d...; Diana Paola Gomez...; Flávia Fonseca Bagno; Natália Satchiko ...; Ana Luiza Chaves ...; Eduardo Burgarell...; Flávio Guimaraes ...; Santuza Maria Rib...; Ana Paula Fernandes; Ricardo Tostes Ga...; Gisele Assis Cast...
• Keywords: Critical quality attributes; Squalene

Aim: To develop, characterize and evaluate an oil/water nanoemulsion with squalene (CTVad1) to be approved as adjuvant for the SpiN COVID-19 vaccine clinical trials. Materials & methods: Critical process parameters (CPPs) of CTVad1 were standardized meet critical quality attributes (CQAs) human use. SpiN-CTVad1 submitted physicochemical, stability, in vitro vivo studies. Results conclusion: All CQAs met production process. SpiN- induced high levels antibodies specific cellular responses These results represented a step developed regulatory requirements trial.