A Phase 2 study of a purified, inactivated virus vaccine to prevent Japanese encephalitis.
A Phase 2 study of a purified, inactivated virus vaccine to prevent Japanese encephalitis.
复制标题
用于预防日本脑炎的纯化灭活病毒疫苗的 2 期研究。
DOI：
10.1016/j.vaccine.2006.12.046
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发表时间：
2007
期刊：
影响因子：
5.5
通讯作者：
D. Vaughn
中科院分区：
文献类型：
--
作者：
A. Lyons;N. Kanesa;R. Kuschner;K. Eckels;R. Putnak;Wellington Sun;R. Burge;A. Towle;Paul Wilson;Erich Tauber;D. Vaughn
Japanese encephalitis (JE) is a serious disease caused by the JE virus. New generation JE vaccines are needed to prevent this disease. We conducted this Phase 2 randomized, open label, unblinded, single center study of a new, cell-culture derived, purified inactivated virus (JE-PIV) vaccine. The JE-PIV vaccine was administered in either two or three intramuscular (IM) doses (6.0 or 12.0mcg each) with observation over 8 weeks. All volunteers completed the protocol without serious adverse reactions. Headache and transient tenderness at the injection site were the most common complaints. There were no laboratory abnormalities believed to be related to vaccine during the study. JE-PIV was well tolerated, resulted in high seroconversion rates [Day 56 (primary endpoint); 95–100%] and induced enduring immune responses up to 2 years after vaccination. Expanded Phase 3 trials are planned.
