Preparedness against pandemic influenza: Production of an oil-in-water emulsion adjuvant in Brazil

Autor(es):Mostrar menos -

Akamatsu, Milena Apetito ^[1] ; Sakihara, Vitor Anselmo ^[1] ; Carvalho, Bianca Pereira ^[1] ; Abrantes, Aline de Paiva ^[1] ; Takano, Maria A. Sakauchi ^[1] ; Adami, Eduardo Alfredo ^[2] ; Yonehara, Fernando Seiji ^[3] ; Carneiro, Patricia dos Santos ^[3] ; Rico, Stefanni ^[4] ; Schanoski, Alessandra ^[4] ; Meros, Mauricio ^[5] ; Simpson, Adrian ^[6] ; Phan, Tony ^[6] ; Fox, Christopher B. ^[6] ; Ho, Paulo Lee ^[1]

Afiliação do(s) autor(es)

^[1] Inst Butantan, Serv Bacteriol, Div BioInd, Sao Paulo - Brazil

^[2] Inst Butantan, Div BioInd, Lab Influenza, Sao Paulo - Brazil

^[3] Inst Butantan, Controle Qualidade, Sao Paulo - Brazil

^[4] Inst Butantan, Lab Bacteriol, Sao Paulo - Brazil

^[5] Inst Butantan, Div Bioind, Sao Paulo - Brazil

^[6] Infect Dis Res Inst, Seattle, WA - USA

• Tipo de documento: Artigo Científico
• Fonte: PLoS One; v. 15, n. 6 JUN 3 2020.
• Citações Web of Science: 0

Resumo

Increasing pandemic influenza vaccine manufacturing capacity is considered strategic by WHO. Adjuvant use is key in this strategy in order to spare the vaccine doses and by increasing immune protection. We describe here the production and stability studies of a squalene based oil-in-water emulsion, adjuvant IB160, and the immune response of the H7N9 vaccine combined with IB160. To qualify the production of IB160 we produced 10 consistency lots of IB160 and the average results were: pH 6.4 +/- 0.05; squalene 48.8 +/-.0.03 mg/ml; osmolality 47.6 +/- 6.9 mmol/kg; Z-average 157 +/- 2 nm, with polydispersity index (PDI) of 0.085 +/- 0.024 and endotoxin levels <0.5 EU/mL. The emulsion particle size was stable for at least six months at 25 degrees C and 24 months at 4-8 degrees C. Two doses of H7N9 vaccine formulated at 7.5 mu g/dose or 15 mu g/dose with adjuvant IB160 showed a significant increase of hemagglutination inhibition (HAI) titers in sera of immunized BALB/c mice when compared to control sera from animals immunized with the H7N9 antigens without adjuvant. Thus the antigen-sparing capacity of IB160 can potentially increase the production of the H7N9 pandemic vaccine and represents an important achievement for preparedness against pandemic influenza and a successful North (IDRI) to South (Butantan Institute) technology transfer for the production of the adjuvant emulsion IB160. (AU)

• Processo FAPESP: 15/25055-8 - Humanização do sistema de glicosilação de Pichia Pastoris pela técnica CRISPR-Cas9 visando a expressão de proteínas recombinantes terapêuticas
• Beneficiário: Paulo Lee Ho
• Modalidade de apoio: Auxílio à Pesquisa - Regular