Quality attributes of CTVad1, a nanoemulsified adjuvant for phase I clinical trial of SpiN COVID-19 vaccine

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. Critical process parameters (CPPs) of CTVad1 were standardized to meet the critical quality attributes (CQAs) of an adjuvant for human u...

Full description

Saved in:
Bibliographic Details
Published in:Nanomedicine (London, England) England), 2023-08, Vol.18 (18), p.1175-1194
Main Authors: Dias Assis, Bruna Rodrigues, Gomes, Isabela Pereira, de Castro, Júlia Teixeira, Rivelli, Graziella Gomes, de Castro, Natália Salazar, Gomez-Mendoza, Diana Paola, Bagno, Flávia Fonseca, Hojo-Souza, Natália Satchiko, Chaves Maia, Ana Luiza, Lages, Eduardo Burgarelli, da Fonseca, Flávio Guimaraes, Ribeiro Teixeira, Santuza Maria, Fernandes, Ana Paula, Gazzinelli, Ricardo Tostes, Castro Goulart, Gisele Assis
Format: Article
Language:English
Subjects:
adjuvant
antibodies
cellular responses
COVID-19
critical quality attributes
nanoemulsion
studies
vaccine
Citations: Items that this one cites
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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. 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, and studies. All CQAs were met in the CTVad1 production process. SpiN- CTVad1 met CQAs and induced high levels of antibodies and specific cellular responses in studies. These results represented a critical step in the process developed to meet regulatory requirements for the SpiN COVID-19 vaccine clinical trial.
ISSN:1743-5889
1748-6963
1748-6963
DOI:10.2217/nnm-2023-0122