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固体生物针剂递送的流感疫苗具有高度热稳定性，并能诱导体液免疫和细胞免疫反应。

Solid bioneedle-delivered influenza vaccines are highly thermostable and induce both humoral and cellular immune responses.

作者信息

Soema Peter C, Willems Geert-Jan, van Twillert Klaas, van de Wijdeven Gijsbert, Boog Claire J, Kersten Gideon F A, Amorij Jean-Pierre

机构信息

Institute for Translational Vaccinology (Intravacc), Bilthoven, The Netherlands.

Bioneedle Technologies Group BV, Eindhoven, The Netherlands.

出版信息

PLoS One. 2014 Mar 26;9(3):e92806. doi: 10.1371/journal.pone.0092806. eCollection 2014.

DOI:10.1371/journal.pone.0092806
PMID:24671048
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3966824/
Abstract

The potential of bioneedles to deliver influenza vaccines was investigated. Four influenza vaccine formulations were screened to determine the optimal formulation for use with bioneedles. The stability of the formulations after freeze-drying was checked to predict the stability of the influenza vaccines in the bioneedles. Subunit, split, virosomal and whole inactivated influenza (WIV) vaccine were formulated and lyophilized in bioneedles, and subsequently administered to C57BL/6 mice. Humoral and cellular immune responses were assessed after vaccination. The thermostability of lyophilized vaccines was determined after one-month storage at elevated temperatures. Bioneedle influenza vaccines induced HI titers that are comparable to those induced by intramuscular WIV vaccination. Delivery by bioneedles did not alter the type of immune response induced by the influenza vaccines. Stability studies showed that lyophilized influenza vaccines have superior thermostability compared to conventional liquid vaccines, and remained stable after one-month storage at 60°C. Influenza vaccines delivered by bioneedles are a viable alternative to conventional liquid influenza vaccines. WIV was determined to be the most potent vaccine formulation for administration by bioneedles. Lyophilized influenza vaccines in bioneedles are independent of a cold-chain, due to their increased thermostability, which makes distribution and stockpiling easier.

摘要

研究了生物针递送流感疫苗的潜力。筛选了四种流感疫苗制剂，以确定与生物针配合使用的最佳制剂。检查冻干后制剂的稳定性，以预测流感疫苗在生物针中的稳定性。将亚单位、裂解、病毒体和全灭活流感（WIV）疫苗在生物针中配制并冻干，随后接种给C57BL/6小鼠。接种疫苗后评估体液和细胞免疫反应。在高温下储存一个月后，测定冻干疫苗的热稳定性。生物针流感疫苗诱导的血凝抑制（HI）效价与肌肉注射WIV疫苗诱导的效价相当。生物针递送不会改变流感疫苗诱导的免疫反应类型。稳定性研究表明，冻干流感疫苗比传统液体疫苗具有更高的热稳定性，在60°C下储存一个月后仍保持稳定。生物针递送的流感疫苗是传统液体流感疫苗的可行替代方案。已确定WIV是通过生物针给药的最有效疫苗制剂。生物针中的冻干流感疫苗由于热稳定性提高而无需冷链，这使得分发和储存更加容易。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee01/3966824/1183ff90378b/pone.0092806.g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee01/3966824/7586a0e5cf49/pone.0092806.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee01/3966824/1b0b63ed2687/pone.0092806.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee01/3966824/162838291809/pone.0092806.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee01/3966824/0b4a9b88a5fb/pone.0092806.g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee01/3966824/1183ff90378b/pone.0092806.g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee01/3966824/7586a0e5cf49/pone.0092806.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee01/3966824/1b0b63ed2687/pone.0092806.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee01/3966824/162838291809/pone.0092806.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee01/3966824/0b4a9b88a5fb/pone.0092806.g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee01/3966824/1183ff90378b/pone.0092806.g005.jpg

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