Preparedness Against Pandemic Influenza: Production of an Oil-in-water Emulsion Adjuvant in Brazil

Overview

Journal PLoS One

Specialties General Medicine
Science

Date 2020 Jun 4

PMID 32492039

Citations 3

Authors

Milena Apetito Akamatsu

Vitor Anselmo Sakihara

Bianca Pereira Carvalho

Aline de Paiva Abrantes

Maria A Sakauchi Takano

Eduardo Alfredo Adami

Fernando Seiji Yonehara

Patricia Dos Santos Carneiro

Stefanni Rico

Alessandra Schanoski

Mauricio Meros

Adrian Simpson

Tony Phan

Christopher B Fox

Paulo Lee Ho

Affiliations

Soon will be listed here.

Abstract

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.

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