Long term follow-up study to evaluate immunogenicity and safety of a single dose of live attenuated hepatitis a vaccine in children

Worldwide, viral hepatitis continues to be a cause of considerable morbidity and mortality. Mass immunization with a single dose of live attenuated HAV has been shown to significantly reduce disease burden in the community. This was a phase IV, 5-year follow up study carried out at 4 centers (Kolkat...

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Veröffentlicht in:Human vaccines & immunotherapeutics 2015-05, Vol.11 (5), p.1147-1152
Hauptverfasser: Mitra, Monjori, Shah, Nitin, Faridi, MMA, Ghosh, Apurba, Sankaranarayanan, VS, Aggarwal, Anju, Chatterjee, Suparna, Bhattacharyya, Nisha, Kadhe, Ganesh, Vishnoi, Gaurav, Mane, Amey
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Sprache:eng
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Zusammenfassung:Worldwide, viral hepatitis continues to be a cause of considerable morbidity and mortality. Mass immunization with a single dose of live attenuated HAV has been shown to significantly reduce disease burden in the community. This was a phase IV, 5-year follow up study carried out at 4 centers (Kolkata, Delhi, Mumbai and Chennai) across India. The subjects with antibody titer 20 mIU/mL, following vaccination starting from 6 weeks, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months were 95.1%, 97.9%, 98.3%, 96.2%, 97.8%, 92.6% and 97.3%, respectively. The geometric mean concentration (GMC) over the years increased from 64.9 mIU/mL at 6 weeks to 38.1 mIU/mL and 135.2 mIU/mL at 6 months and 12 months, respectively and was maintained at 127.1 mIU/mL at 60 months. In conclusion, the result of this 5-year follow up study showed that the single dose of live attenuated vaccine is well tolerated and provides long-term immunogenicity in healthy Indian children.
ISSN:2164-5515
2164-554X
DOI:10.4161/21645515.2014.979646