双价1型和3型口服脊髓灰质炎疫苗的免疫性:一个随机,双盲,受控试验
Roland W Sutter1, T Jacob John, Hemant Jain
1World Health Organization, Geneva, Switzerland. sutterr@who.int
Lancet (London, England)
|October 29, 2010
概括
一种新的双价1型和3型口服脊髓灰质炎疫苗 (bOPV) 显示出优于三价OPV (tOPV). 这种bOPV也被发现与单价OPV类型1和3 (mOPV1和mOPV3) 不逊色.
科学领域:
- * 病毒学和免疫学
- * 疫苗开发和临床试验
- * 公共卫生和流行病学
背景情况:
- *1型和3型脊髓灰质炎病毒在脊髓灰质炎仍然流行的国家和地区共传播.
- *需要评估用于控制小儿麻症病毒的新型疫苗配方的免疫性.
研究的目的:
- *评估一种新的双价1型和3型口服脊髓灰质炎疫苗 (bOPV) 的免疫性.
- * 为了比较bOPV对单价OPV类型1,2和3 (mOPV1,mOPV2,mOPV3) 和三价OPV (tOPV) 的疗效.
主要方法:
- * 一项随机,双盲,受控试验,涉及印度900名新生儿.
- *参与者被分配接受mOPV1,mOPV2,mOPV3,bOPV或tOPV.
- * 主要结局:一剂后血清转换;二次结局:两剂后血清转换.
主要成果:
- *两剂后,1型脊髓灰质炎病毒的累积血清转化为bOPV的86%,而tOPV为63% (p<0.0001).
- *3型脊髓灰质炎病毒的累积血清转化为bOPV的74%,而tOPV的52% (p<0.0001).
- *bOPV疫苗耐受性良好,没有严重的不良事件归因于干预.
结论:
- *两价1型和3型口服脊髓灰质炎疫苗 (bOPV) 优于三价OPV (tOPV).
- *与单价OPV类型1和3 (mOPV1和mOPV3) 相比,bOPV显示出非劣质性.
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