Quality attributes of CTVad1, a nanoemulsified adjuvant for phase I clinical trial of SpiN COVID-19 vaccine-Reference-Cited by-同舟云学术

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

Published:2023-08 Issue:18 Volume:18 Page:1175-1194
ISSN:1743-5889
Container-title:Nanomedicine
language:en
Short-container-title:Nanomedicine

Author:

Dias Assis Bruna Rodrigues¹²^ORCID,Gomes Isabela Pereira²^ORCID,de Castro Júlia Teixeira²^ORCID,Rivelli Graziella Gomes²^ORCID,de Castro Natália Salazar²^ORCID,Gomez-Mendoza Diana Paola²^ORCID,Bagno Flávia Fonseca²^ORCID,Hojo-Souza Natália Satchiko²³^ORCID,Chaves Maia Ana Luiza²^ORCID,Lages Eduardo Burgarelli²^ORCID,da Fonseca Flávio Guimaraes²⁴^ORCID,Ribeiro Teixeira Santuza Maria²⁵^ORCID,Fernandes Ana Paula²⁶^ORCID,Gazzinelli Ricardo Tostes²³⁵^ORCID,Castro Goulart Gisele Assis¹²^ORCID

Affiliation:

1. Department of Pharmaceuticals, Faculty of Pharmacy, Universidade Federal de Minas Gerais, Belo Horizonte, MG, 31270-901, Brazil

2. Centro de Tecnologia de Vacinas da Universidade Federal de Minas Gerais, Belo Horizonte, Belo Horizonte, MG, 31310-260, Brazil

3. Instituto René Rachou, Fundação Oswaldo Cruz-Minas, Belo Horizonte, MG, 30190-002, Brazil

4. Department of Microbiology, Institute of Biological Sciences, Universidade Federal de Minas Gerais, Belo Horizonte, MG, 31270-901, Brazil

5. Department of Biochemistry & Immunology, Institute of Biological Sciences, Universidade Federal de Minas Gerais, Belo Horizonte, MG, 31270-901, Brazil

6. Department of Clinical & Toxicological Analysis, Faculty of Pharmacy, Universidade Federal de Minas Gerais, Belo Horizonte, MG, 31270-901, 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.

Funder

Parliamentary Amendment of State and Federal Representatives from Minas Gerais

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Fundação de Amparo à Pesquisa do Estado de São Paulo

Fundação de Amparo à Pesquisa do Estado de Minas Gerais

Financiadora de Estudos e Projetos

Fundação Oswaldo Cruz

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior

Prefeitura de Belo Horizonte

Publisher

Future Medicine Ltd

Subject

Development,General Materials Science,Biomedical Engineering,Medicine (miscellaneous),Bioengineering

Link

https://www.futuremedicine.com/doi/pdf/10.2217/nnm-2023-0122

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