| Author | Assis, Bruna Rodrigues Dias | |
| Author | Gomes, Isabela Pereira | |
| Author | Castro, Júlia Teixeira de | |
| Author | Rivelli, Graziella Gomes | |
| Author | Castro, Natália Salazar de | |
| Author | Gomez-Mendoza, Diana Paola | |
| Author | Bagno, Flávia Fonseca | |
| Author | Hojo-Souza, Natália Satchiko | |
| Author | Maia, Ana Luiza Chaves | |
| Author | Lages, Eduardo Burgarelli | |
| Author | Fonseca, Flávio Guimaraes da | |
| Author | Teixeira, Santuza Maria Ribeiro | |
| Author | Fernandes, Ana Paula | |
| Author | Gazzinelli, Ricardo Tostes | |
| Author | Goulart, Gisele Assis Castro | |
| Access date | 2023-11-07T19:35:51Z | |
| Available date | 2023-11-07T19:35:51Z | |
| Document date | 2023 | |
| 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. | en_US |
| ISSN | 1743-5889 | en_US |
| URI | https://www.arca.fiocruz.br/handle/icict/61086 | |
| Language | eng | en_US |
| Publisher | Future Medicine Ltd | en_US |
| Rights | restricted access | |
| Title | Quality attributes of CTVad1, a nanoemulsified adjuvant for phase I clinical trial of SpiN COVID-19 vaccine | en_US |
| Type | Article | |
| DOI | 10.2217/nnm-2023-0122 | |
| 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. | en_US |
| 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. | en_US |
| Affilliation | Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas Belo Horizonte. Belo Horizonte, MG, Brazil. | en_US |
| Affilliation | Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas Belo Horizonte. Belo Horizonte, MG, Brazil. | en_US |
| Affilliation | Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas Belo Horizonte. Belo Horizonte, MG, Brazil. | en_US |
| Affilliation | Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas Belo Horizonte. Belo Horizonte, MG, Brazil. | en_US |
| Affilliation | Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas Belo Horizonte. Belo Horizonte, MG, Brazil. | en_US |
| Affilliation | Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas Belo Horizonte. Belo Horizonte, MG, Brazil. | en_US |
| Affilliation | 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. | en_US |
| Affilliation | Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas Belo Horizonte. Belo Horizonte, MG, Brazil | en_US |
| Affilliation | Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas Belo Horizonte. Belo Horizonte, MG, Brazil. | en_US |
| Affilliation | 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. | en_US |
| Affilliation | 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. | en_US |
| Affilliation | 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. | en_US |
| Affilliation | 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. | en_US |
| 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. | en_US |
| Subject | COVID-19 | en_US |
| Subject | Adjuvant | en_US |
| Subject | Antibodies | en_US |
| Subject | Cellular responses | en_US |
| Subject | Critical quality attributes | en_US |
| Subject | In vivo studies | en_US |
| Subject | Nanoemulsion | en_US |
| Subject | Vaccine | en_US |
| Embargo date | 3100-12-31 | |
| xmlui.metadata.dc.subject.ods | 03 Saúde e Bem-Estar | |
