Development and efficacy evaluation of a novel water-in-oil-in-water adjuvant for an inactivated foot-and-mouth disease vaccine.

IF 2.6 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pharmaceutical Development and Technology Pub Date : 2024-02-01 Epub Date: 2024-01-17 DOI:10.1080/10837450.2024.2305107
Rong Zhang, Yanming Wei, Xuerong Liu, Yongshu Wu
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Abstract

To develop a novel water-in-oil-in-water (W/O/W) adjuvant and evaluate the effect on foot-and-mouth disease (FMD) inactivated vaccine, in this study, we prepared the novel nano-emulsion adjuvant based on QS-21 (BEA) which is composed of the mixture of mineral oil Marcol52, surfactant Tween80, oleate polyoxyethylene ether ester, polyoxyethylene palmitic acid ester and span80, cosurfactant polyethylene glycol and QS-21. The two-step emulsification method formed the W/O/W nano-emulsion with two films and three-phase structures. The effective particle diameter of the BEA was about 184 nm, and it has good thermal stability. Then, BEA was emulsified as an adjuvant to prepare for the inactivated FMDV vaccine, and BALB/c mice and pigs were immunized to evaluate its safety and immunization effect. The results showed that the inactivated BEA-FMDV vaccine significantly increased BALB/c mice and pigs' antibodies and cytokine IFN-γ in serum. Meanwhile, the pig-neutralizing antibodies were higher than control group. Safety tests found no symptoms of FMD or significant toxic reactions. After 28 days of immunization, the protection rate can reach 93.3%. The BEA vaccine had good stability at 4 °C, no stratification after 180 days, and the content of 146S in the vaccine did not decrease. In conclusion, the BEA prepared in this study is suitable for FMDV inactivated vaccine and is an effective adjuvant.

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用于口蹄疫灭活疫苗的新型水包油佐剂的开发与药效评估
为了开发一种新型水包油(W/O/W)佐剂并评估其对口蹄疫(FMD)灭活疫苗的效果,本研究制备了基于 QS-21 的新型纳米乳液佐剂(BEA),该佐剂由矿物油 Marcol52、表面活性剂 Tween80、油酸聚氧乙烯醚酯、聚氧乙烯棕榈酸酯和 span80、共表面活性剂聚乙二醇和 QS-21 混合组成。两步乳化法形成了两膜三相结构的 W/O/W 纳米乳液。BEA 的有效粒径约为 184 nm,具有良好的热稳定性。然后,以BEA为佐剂乳化制备口蹄疫灭活疫苗,并对BALB/c小鼠和猪进行免疫接种,以评价其安全性和免疫效果。结果表明,BEA-FMDV 灭活疫苗能显著增加 BALB/c 小鼠和猪的抗体和血清中的细胞因子 IFN-γ。同时,猪中和抗体高于对照组。安全性试验未发现 FMD 症状或明显的毒性反应。免疫 28 天后,保护率可达 93.3%。BEA 疫苗在 4 °C 下稳定性良好,180 天后无分层现象,疫苗中 146S 的含量也没有降低。总之,本研究制备的 BEA 适用于口蹄疫病毒灭活疫苗,是一种有效的佐剂。
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来源期刊
CiteScore
5.90
自引率
2.90%
发文量
82
审稿时长
1 months
期刊介绍: Pharmaceutical Development & Technology publishes research on the design, development, manufacture, and evaluation of conventional and novel drug delivery systems, emphasizing practical solutions and applications to theoretical and research-based problems. The journal aims to publish significant, innovative and original research to advance the frontiers of pharmaceutical development and technology. Through original articles, reviews (where prior discussion with the EIC is encouraged), short reports, book reviews and technical notes, Pharmaceutical Development & Technology covers aspects such as: -Preformulation and pharmaceutical formulation studies -Pharmaceutical materials selection and characterization -Pharmaceutical process development, engineering, scale-up and industrialisation, and process validation -QbD in the form a risk assessment and DoE driven approaches -Design of dosage forms and drug delivery systems -Emerging pharmaceutical formulation and drug delivery technologies with a focus on personalised therapies -Drug delivery systems research and quality improvement -Pharmaceutical regulatory affairs This journal will not consider for publication manuscripts focusing purely on clinical evaluations, botanicals, or animal models.
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