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

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 ?g/dose or 15 ?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.

SUBMITTER: Akamatsu MA

PROVIDER: S-EPMC7269237 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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

Akamatsu Milena Apetito MA Sakihara Vitor Anselmo VA Carvalho Bianca Pereira BP de Paiva Abrantes Aline A Takano Maria A Sakauchi MAS Adami Eduardo Alfredo EA Yonehara Fernando Seiji FS Dos Santos Carneiro Patrícia P Rico Stefanni S Schanoski Alessandra A Meros Maurício M Simpson Adrian A Phan Tony T Fox Christopher B CB Ho Paulo Lee PL

PloS one 20200603 6

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; ...[more]

PMID: 32492039

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Project description:Background:Application of topical moisturizers is an essential part of the management of atopic dermatitis (AD). Linoleic acid (LA), the most abundant fatty acid in the epidermis, and its derivatives have an essential role in the structure and function of the epidermal barrier, and their defects are prominent in AD. The aim of this study was to compare the efficacy and safety of two cosmetic products containing either LA or urea in patients with AD. Patients and methods:A total of 20 patients with AD who met the eligibility criteria and provided written informed consents were enrolled in this randomized, intra-individual split-body, single-center trial. Symmetrical lesions of patients were randomized for treatment with LA- or urea-containing water-in-oil (w/o) emulsions applied two to three times daily for 4 weeks. The efficacy of the two products was evaluated by local Scoring Atopic Dermatitis (SCORAD) of both lesions and also patient (or guardian) satisfaction. In addition, trans-epidermal water loss (TEWL), stratum corneum (SC) hydration, pH, sebum, temperature, erythema, melanin content, and ultrasonographic thickness and echo density of epidermis and dermis were measured before, and 2 and 4 weeks after, treatment. Results:Four weeks of treatment with the LA-containing product resulted in a significant decrease in local SCORAD, TEWL, erythema, and echo density of dermis, as well as an increase in SC hydration compared to baseline. The urea-containing product also reduced the local SCO-RAD and echo density of dermis and increased SC hydration. In contrast to the LA-containing product, changes in TEWL and erythema were not significant. Moreover, the reduction of erythema was significantly higher in the LA-containing product-treated side compared to the urea-containing product-treated side (p = 0.006). Conclusion:Both LA- or urea-containing w/o emulsions can significantly improve barrier dysfunction and clinical severity of AD. In agreement with literature, it was confirmed that an LA-containing w/o emulsion exhibited erythema-reducing effects. Since emollients should be used on a regular basis, patients should choose a product by individual preference following recommendation by their dermatologists.

Dataset Information

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

Publications

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

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