Preparedness against pandemic influenza: Production of an oil-in-water emulsion adjuvant in Brazil.
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,...
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doaj-aa09ccaba4e44f8ca9e634c55b6f31222021-03-03T21:50:33ZengPublic Library of Science (PLoS)PLoS ONE1932-62032020-01-01156e023363210.1371/journal.pone.0233632Preparedness against pandemic influenza: Production of an oil-in-water emulsion adjuvant in Brazil.Milena Apetito AkamatsuVitor Anselmo SakiharaBianca Pereira CarvalhoAline de Paiva AbrantesMaria A Sakauchi TakanoEduardo Alfredo AdamiFernando Seiji YoneharaPatrícia Dos Santos CarneiroStefanni RicoAlessandra SchanoskiMaurício MerosAdrian SimpsonTony PhanChristopher B FoxPaulo Lee HoIncreasing 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°C and 24 months at 4-8°C. Two doses of H7N9 vaccine formulated at 7.5 μg/dose or 15 μg/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.https://doi.org/10.1371/journal.pone.0233632 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Milena Apetito Akamatsu Vitor Anselmo Sakihara Bianca Pereira Carvalho Aline de Paiva Abrantes Maria A Sakauchi Takano Eduardo Alfredo Adami Fernando Seiji Yonehara Patrícia Dos Santos Carneiro Stefanni Rico Alessandra Schanoski Maurício Meros Adrian Simpson Tony Phan Christopher B Fox Paulo Lee Ho |
spellingShingle |
Milena Apetito Akamatsu Vitor Anselmo Sakihara Bianca Pereira Carvalho Aline de Paiva Abrantes Maria A Sakauchi Takano Eduardo Alfredo Adami Fernando Seiji Yonehara Patrícia Dos Santos Carneiro Stefanni Rico Alessandra Schanoski Maurício Meros Adrian Simpson Tony Phan Christopher B Fox Paulo Lee Ho Preparedness against pandemic influenza: Production of an oil-in-water emulsion adjuvant in Brazil. PLoS ONE |
author_facet |
Milena Apetito Akamatsu Vitor Anselmo Sakihara Bianca Pereira Carvalho Aline de Paiva Abrantes Maria A Sakauchi Takano Eduardo Alfredo Adami Fernando Seiji Yonehara Patrícia Dos Santos Carneiro Stefanni Rico Alessandra Schanoski Maurício Meros Adrian Simpson Tony Phan Christopher B Fox Paulo Lee Ho |
author_sort |
Milena Apetito Akamatsu |
title |
Preparedness against pandemic influenza: Production of an oil-in-water emulsion adjuvant in Brazil. |
title_short |
Preparedness against pandemic influenza: Production of an oil-in-water emulsion adjuvant in Brazil. |
title_full |
Preparedness against pandemic influenza: Production of an oil-in-water emulsion adjuvant in Brazil. |
title_fullStr |
Preparedness against pandemic influenza: Production of an oil-in-water emulsion adjuvant in Brazil. |
title_full_unstemmed |
Preparedness against pandemic influenza: Production of an oil-in-water emulsion adjuvant in Brazil. |
title_sort |
preparedness against pandemic influenza: production of an oil-in-water emulsion adjuvant in brazil. |
publisher |
Public Library of Science (PLoS) |
series |
PLoS ONE |
issn |
1932-6203 |
publishDate |
2020-01-01 |
description |
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°C and 24 months at 4-8°C. Two doses of H7N9 vaccine formulated at 7.5 μg/dose or 15 μg/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. |
url |
https://doi.org/10.1371/journal.pone.0233632 |
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