| Author | Bastos, Renata Chagas | |
| Author | Corrêa, Marilza Batista | |
| Author | Souza, Iaralice Medeiros de | |
| Author | Silva, Milton Neto da | |
| Author | Pereira, Denise da Silva Gomes | |
| Author | Martins, Fernanda Otaviano | |
| Author | Faria, Camila da Silva | |
| Author | Ano Bom, Ana Paula Dinis | |
| Author | Leal, Maria de Lourdes | |
| Author | Jessouroun, Ellen | |
| Author | Silva Júnior, José Godinho da | |
| Author | Medronho, Ricardo de Andrade | |
| Author | Silveira, Ivna Alana Freitas Brasileiro da | |
| Access date | 2024-04-22T14:52:24Z | |
| Available date | 2024-04-22T14:52:24Z | |
| Document date | 2018 | |
| Citation | BASTOS, Renata Chagas et al. Brazilian meningococcal C conjugate vaccine: physicochemical, immunological, and thermal stability characteristics. Glycoconjugate Journal, v. 35, n. 1, p. 3-13, Feb. 2018. | en_US |
| ISSN | 0282-0080 | en_US |
| URI | https://www.arca.fiocruz.br/handle/icict/63619 | |
| Language | eng | en_US |
| Publisher | Springer | en_US |
| Rights | restricted access | |
| Title | Brazilian meningococcal C conjugate vaccine: physicochemical, immunological, and thermal stability characteristics | en_US |
| Type | Article | |
| DOI | 10.1007/s10719-017-9787-2 | |
| Abstract | High temperature is known to cause some instability in polysaccharide-protein conjugated vaccines and studies under stress conditions may be useful in determining whether short-term accidental exposure to undesired conditions can compromise product quality. In this study, we examined the structural stability of three industrial batches of Brazilian Meningococcal C conjugate bulk (MPCT) incubated at 4, 37, and 55 °C for 5 weeks. The effect of exposure to the storage temperatures was monitored by HPLC-SEC, CZE, CD and NMR techniques. The immunological significance of any physicochemical changes observed in MPCT was determined by SBA and ELISA assays of serum from immunized mice. Fluorescence emission spectra at 4 and 37 °C were similar among all samples and compatible with the native fold of the carrier protein. Fluorescence spectra of MPCT stored at 55 °C decreased in intensity and had a significant red-shift, indicating conformational changes. Far-UV CD spectra revealed a trend toward loss of structural conformation as storage temperature was increased to 55 °C. The NMR data showed modified signal intensity of the aromatic and aliphatic residues, mainly for samples incubated at 55 °C, suggesting a partial loss of tertiary structure. About 50% free saccharide content was found in bulks stored at 55 °C, but no difference was observed in the IgG or SBA titers. The present study showed physicochemical methods alone are insufficient to predict the biological activity of a MPCT conjugate vaccine without extensive validation against immunological data. However, they provide a sensitive means of detecting changes induced in a vaccine exposed to adverse environmental condition. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos). Laboratório de Macromoléculas. Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos). Laboratório de Tecnologia Bacteriana. Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos). Laboratório de Tecnologia Bacteriana. Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos). Laboratório de Tecnologia Bacteriana. Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos). Laboratório de Tecnologia Bacteriana. Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos). Laboratório de Tecnologia Bacteriana. Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos). Laboratório de Tecnologia Bacteriana. Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos). Laboratório de Macromoléculas. Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos). Laboratório de Tecnologia Bacteriana. Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos). Programa de Vacinas Bacterianas. Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos). Laboratório de Macromoléculas. Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Universidade Federal do Rio de Janeiro. Escola de Química. Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos). Laboratório de Tecnologia Bacteriana. Rio de Janeiro, RJ, Brasil. | en_US |
| Subject | Brazilian meningococcal C conjugate vaccine | en_US |
| Subject | Thermo stability | en_US |
| Subject | Physicochemical analysis | en_US |
| Subject | Immunological evaluation | en_US |
| Embargo date | 2030-12-31 | |
| xmlui.metadata.dc.subject.ods | 03 Saúde e Bem-Estar | |
