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3100-12-31
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QUALITY ATTRIBUTES OF CTVAD1, A NANOEMULSIFIED ADJUVANT FOR PHASE I CLINICAL TRIAL OF SPIN COVID-19 VACCINE
Assis, Bruna Rodrigues Dias et al. | Date Issued: 2023
Author
Assis, Bruna Rodrigues Dias
Gomes, Isabela Pereira
Castro, Júlia Teixeira de
Rivelli, Graziella Gomes
Castro, Natália Salazar de
Gomez-Mendoza, Diana Paola
Bagno, Flávia Fonseca
Hojo-Souza, Natália Satchiko
Maia, Ana Luiza Chaves
Lages, Eduardo Burgarelli
Fonseca, Flávio Guimaraes da
Teixeira, Santuza Maria Ribeiro
Fernandes, Ana Paula
Gazzinelli, Ricardo Tostes
Goulart, Gisele Assis Castro
Affilliation
Universidade Federal de Minas Gerais. Faculty of Pharmacy. Department of Pharmaceuticals. Belo Horizonte, MG, Brazil / Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas Belo Horizonte. Belo Horizonte, MG, Brazil.
Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas Belo Horizonte. Belo Horizonte, MG, Brazil.
Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas Belo Horizonte. Belo Horizonte, MG, Brazil.
Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas Belo Horizonte. Belo Horizonte, MG, Brazil.
Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas Belo Horizonte. Belo Horizonte, MG, Brazil.
Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas Belo Horizonte. Belo Horizonte, MG, Brazil.
Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas Belo Horizonte. Belo Horizonte, MG, Brazil.
Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas Belo Horizonte. Belo Horizonte, MG, Brazil / Fundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brazil.
Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas Belo Horizonte. Belo Horizonte, MG, Brazil
Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas Belo Horizonte. Belo Horizonte, MG, Brazil.
Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas Belo Horizonte. Belo Horizonte, MG, Brazil / Universidade Federal de Minas Gerais. Institute of Biological Sciences. Department of Microbiology. Belo Horizonte, MG, Brazil.
Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas Belo Horizonte. Belo Horizonte, MG, Brazil / Universidade Federal de Minas Gerais. Institute of Biological Sciences. Department of Biochemistry & Immunology.Belo Horizonte, MG, Brazil.
Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas Belo Horizonte. Belo Horizonte, MG, Brazil / Universidade Federal de Minas Gerais. Faculty of Pharmacy. Department of Clinical & Toxicological Analysis. Belo Horizonte, MG, Brazil.
Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas Belo Horizonte. Belo Horizonte, MG, Brazil / Fundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brazil / Universidade Federal de Minas Gerais. Institute of Biological Sciences. Department of Microbiology. Belo Horizonte, MG, Brazil / Universidade Federal de Minas Gerais. Institute of Biological Sciences. Department of Biochemistry & Immunology. Belo Horizonte, MG, Brazil.
Universidade Federal de Minas Gerais. Faculty of Pharmacy. Department of Pharmaceuticals. Belo Horizonte, MG, Brazil / Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas Belo Horizonte. Belo Horizonte, MG, Brazil.
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.
Keywords
COVID-19
Adjuvant
Antibodies
Cellular responses
Critical quality attributes
In vivo studies
Nanoemulsion
Vaccine
 
Publisher
Future Medicine Ltd
Citation
ASSIS, Bruna Rodrigues Dias et al. Quality attributes of CTVad1, a nanoemulsified adjuvant for phase I clinical trial of SpiN COVID-19 vaccine. Nanomedicine, v. 18, n. 18, p. 1175-1194, 2023.
DOI
10.2217/nnm-2023-0122
ISSN
1743-5889