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Three administrations of vaccine doses of 1 X 10(4) ffu and 1 X 10(5) ffu were safe. The 1 X 10(5)-ffu dose of 116E demonstrated a robust immune response after 3 administrations. These favorable results warrant further development of the vaccine candidate and provide optimism that vaccinating infants in the developing world will prevent serious sequelae of rotavirus infection. Clinical trials registration. NCT00439660 and ISRCTN57452882 .

Decades of efforts have resulted in understanding various aspects of human Ad 5 biology as well as the in vivo behavior of vectors derived from this serotype. While this vector has shown great potential, some of the limitations highlighted in recent studies have reinforced the quest for an ideal vector derived from novel Ads. Combinatorial approaches to address the various limitations of the existing vectors must be pursued to develop novel vectors with enhanced clinical potential.

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