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

Society for Applied Studies, New Delhi, India.
Vaccine (Impact Factor: 3.62). 08/2006; 24(31-32):5817-23. DOI: 10.1016/j.vaccine.2006.05.001
Source: PubMed


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.

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    • "Particularly for countries like India, where respiratory infection and diarrhoea each contribute >10% to the mortality burden in young children [3], there is a need for safe, effective and affordable vaccines for use in the public health system. Investments in vaccine development require an appetite for risk taking and long term investment, given to the vaccine [5]. The development was then taken forward to late phase II and then phase III with the 116E candidate, under the leadership of Nita Bhandari at the Society for Applied Studies, a non-governmental organization formed of researchers formerly at AIIMS, committed to child health research. "

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    • "In that study, 116E like G9 strains were found to confer protection against severe RV diarrhoea and also elicited potent immune response thereby confirming its immunogenicity. The recently conducted vaccine trial with the 116E strain also demonstrated high immunogenicity among the vaccinated children (Bhandari et al., 2006, 2009). Neutralization of Fig. 1. "
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    ABSTRACT: The emergence of G12 rotaviruses raises questions about the ability of candidate vaccines in providing protection against such emerging genotypes. Therefore, we assessed cross-neutralization against four reference rotavirus strains namely Wa (G1P[8]), DS-1 (G2P[4]), 116E (G9P[11]) and RV024 (G12P[6]) using paired sera from 28 children infected with G1P[8], G2P[4], G9P[6/8] or G12P[6] genotypes. Convalescent sera of G12P[6]-infected children demonstrated heterotypic response against 116E and Wa strains (50 and 33.3 %). In contrast, none of the four G2P[4]-infected children seroconverted against Wa or RV024 rotaviruses. The geometric mean neutralizing antibody titre in convalescent sera of G12P[6]-infected children was eightfold higher against strains belonging to the Wa genogroup (i.e. G1, G9 and G12 rotavirus) than against strains belonging to the DS-1 genogroup (G2 rotavirus). In conclusion, this study demonstrates that neutralization in part may be genogroup specific, and thus a monovalent vaccine based on the Wa genogroup is likely to protect against the G12 rotaviruses.
    Preview · Article · Mar 2010 · Journal of General Virology
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