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

Bhandari, Nita and Sharma, Pooja and Glass, Roger I and Ray, Pratima and Greenberg, Harry and Taneja, Sunita and Saksena, Manju and Rao, Durga C and Gentsch, Jon R and Parashar, Umesh and Maldonado, Yvonne and Ward, Richard L and Bhan, MK (2006) Safety and immunogenicity of two live attenuated human rotavirus vaccine candidates, 116E and I321, in infants: Results of a randomised controlled trial. In: Vaccine, 24 (31-32). pp. 5817-5823.

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Abstract

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

Item Type:	Journal Article
Publication:	Vaccine
Publisher:	Elsavier
Additional Information:	Copyright of this article belongs to Elsavier.
Keywords:	Rotavirus vaccine;Safety;Immunogenicity.
Department/Centre:	Division of Biological Sciences > Microbiology & Cell Biology
Date Deposited:	08 Apr 2009 08:46
Last Modified:	19 Sep 2010 04:58
URI:	http://eprints.iisc.ac.in/id/eprint/17800

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