Bhandari Nita, Sharma Pooja, Glass Roger I, Ray Pratima, Greenberg Harry, Taneja Sunita, Saksena Manju, Rao C Durga, Gentsch Jon R, Parashar Umesh, Maldonado Yvonne, Ward Richard L, Bhan M K
Society for Applied Studies, New Delhi, India.
Vaccine. 2006 Jul 26;24(31-32):5817-23. doi: 10.1016/j.vaccine.2006.05.001. Epub 2006 May 12.
We evaluated safety and immunogenicity of two orally administered human rotavirus vaccine candidates 116E and I321. Ninety healthy infants aged 8 weeks received a single dose of 116E (10(5)FFu (florescence focus units)), I321 (10(5)FFu) or placebo. There were no significant differences in the number of adverse events. Fever was reported by 6/30, 1/30 and 5/30 in the 116E, I321 and placebo groups; the corresponding figures for diarrhoea were 5/30, 8/29 and 3/30. Serum IgA seroconversion rates were 73%, 39% and 20% in the 116E, I321 and placebo groups, respectively. Vaccine virus was shed on days 3, 7 or 28 in 11/30 infants of the 116E and none in the other two groups. The 116E strain is attenuated, clinically safe and highly immunogenic with a single dose.
我们评估了两种口服人轮状病毒候选疫苗116E和I321的安全性和免疫原性。90名8周龄的健康婴儿分别接受单剂量的116E（10⁵荧光灶单位（FFu））、I321（10⁵FFu）或安慰剂。不良事件的数量没有显著差异。116E组、I321组和安慰剂组报告发热的人数分别为6/30、1/30和5/30；腹泻的相应数字分别为5/30、8/29和3/30。116E组、I321组和安慰剂组的血清IgA血清转化率分别为73%、39%和20%。116E组30名婴儿中有11名在第3天、第7天或第28天排出疫苗病毒，其他两组均无。116E毒株减毒，临床安全，单剂量具有高度免疫原性。
