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在健康成年人中,两种新的活体减弱单价 (血清型2) 口服脊髓灰质炎疫苗的安全性和免疫性:双盲单中心第一阶段研究
Pierre Van Damme1, Ilse De Coster1, Ananda S Bandyopadhyay2
1Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium.
Lancet (London, England)
|June 9, 2019
概括
新型口服脊髓灰质炎疫苗 (OPV2) 在先前用失活脊髓灰质炎疫苗 (IPV) 接种的成年人中显示出安全性和免疫性. 这些基因稳定的OPV2候选人提供了较低的神经毒性风险,支持全球脊髓灰质炎根除工作.
科学领域:
- 病毒学和疫苗学
- 公共卫生
- 传染病流行病学
背景情况:
- 口服活体减弱型脊髓灰质炎疫苗 (OPV) 和失活型脊髓灰质炎疫苗 (IPV) 几乎消除了野生脊髓灰质炎病毒.
- 开发了新的单价OPV2候选物,以保持基因稳定,降低神经毒性逆转的风险.
- 这项研究标志着这些新型OPV2候选药物的第一次人类安全性和免疫性评估.
研究的目的:
- 评估两种新型口服2型脊髓灰质炎疫苗候选者的安全性和免疫性.
- 评估疫苗病毒在便中的存在,程度和持续时间.
- 通过对人类进行的首次试验来确定病毒的神经毒性.
主要方法:
- 一个双盲,单中心的第一阶段试验,涉及30名先前接种了IPV的健康成年人.
- 参与者在隔离设施中被隔离,并接受了两种OPV2候选药物的单剂量.
- 监测包括不良事件,免疫反应,便分泌和分泌病毒分离的遗传稳定性.
主要成果:
- 两种OPV2候选药物均具有免疫性,在所有参与者中诱导血清中和抗体.
- 没有严重的不良事件发生;严重的事件 (主要是肌酸酶升高) 在40%和60%的参与者报告.
- 在100%和87%的参与者中观察到便分泌,候选型2的持续时间较短,病毒载量较低.
结论:
- 新型OPV2候选药物在IPV免疫成年人中显示出可接受的安全性和免疫性.
- 在关键遗传区域没有减弱,观察到神经毒性回归率较低.
- 这些发现支持进一步开发这些OPV2候选物来维持2型脊髓灰质炎病毒的全球根除.
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