Safety and immunogenicity of two live attenuated human rotavirus vaccine candidates, 116E and I321, in infants: Results of a randomised controlled trial

被引：51

作者：

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.

机构：

[1] Govt India, Dept Biotechnol, New Delhi 110003, India

[2] Soc Appl Studies, New Delhi, India

[3] Ctr Dis Control, Viral Gastroenteritis Team, Atlanta, GA 30333 USA

[4] All India Inst Med Sci, Dept Paediat, New Delhi 110029, India

[5] Stanford Univ, Sch Med, Stanford, CA 94305 USA

[6] Indian Inst Sci, Dept Microbiol & Cell Biol, Bangalore 560012, Karnataka, India

[7] Childrens Hosp & Med Ctr, Div Infect Dis, Cincinnati, OH USA

来源：

VACCINE | 2006年 / 24卷 / 31-32期

关键词：

rotavirus vaccine; safety; immunogenicity;

D O I：

10.1016/j.vaccine.2006.05.001

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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)), 1321 (105 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, 1321 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, 1321 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. (c) 2006 Elsevier Ltd. All rights reserved.

引用

页码：5817 / 5823

页数：7

共 20 条

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