活体减弱性Vibrio cholerae O139疫苗原型的安全性,免疫性和有效性
T S Coster1, K P Killeen, M K Waldor
1Clinical Studies Branch, US Army Medical Research Institute of Infectious Diseases, Fort Detrick, Frederick, MD 21702-5011, USA.
Lancet (London, England)
|April 15, 1995
概括
一个新的活体减弱疫苗候选人,Bengal-15,显示出它有望预防由Vibrio cholerae O139.e引起的霍乱. 这种口服疫苗在人体试验中显示出83%的保护效果,副作用最小.
科学领域:
- 微生物学和免疫学
- 疫苗开发 疫苗开发
- 预防传染病 预防传染病
背景情况:
- 新兴需要针对Vibrio cholerae O139 (V. cholerae O139) 的有效疫苗,以防止霍乱爆发.
- 开发减弱的Vibrio cholerae O139菌株作为潜在的口服疫苗候选人.
研究的目的:
- 评估新型活体减弱Vibrio cholerae O139候选疫苗的安全性和免疫性.
- 为了评估最有前途的候选人孟加拉-15对V. cholerae O139挑战的保护效果.
主要方法:
- 通过删除霍乱毒素元素和修改毒素子单元表达,产生减弱的V. cholerae O139菌株 (孟加拉-3,VRI-16,孟加拉-15).
- 第1期临床试验涉及口服注射候选疫苗给小组志愿者.
- 在接种疫苗的个体和对照人群中对毒性V. cholerae O139进行后续挑战研究,以确定保护性疗效.
主要成果:
- 最初的试验显示了不同的安全性和免疫性概况;孟加拉-15呈现了很少的症状和显著的免疫性.
- 随后对Bengal-15 (10^8 CFU) 进行的一项试验表明,缓冲受试者没有腹和相似的轻度症状.
- 挑战性研究显示,Bengal-15的保护效率为83%,与6个对照组中的5个相比,只有7个接种疫苗的1个患有轻度腹.
结论:
- 活体减弱的Vibrio cholerae O139疫苗候选人孟加拉-15是安全的,并显示出显著的保护性有效性.
- 孟加拉-15代表了一种有前途的口服疫苗,用于预防由O139血清组引起的霍乱.
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