Safety, dose, immunogenicity, and transmissibility of an oral live attenuated Shigella flexneri 2a vaccine candidate (SC602) among healthy adults and school children in Matlab, Bangladesh

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Rahman, Kazi M.
Arifeen, Shams
Zaman, K.
Rahman, M.
Raqib, R.
Yunus, M.
Begum, N.
Islam, M.S.
Sohel, B.M.
Rahman, Muntasirur
Venkatesan, Malabi
Hale, T.L.
Isenbarger, D.W.
Sansonetti, P.J.
Black, Robert
Baqui, A.H.
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2011
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Abstract

In double-blind trials in Bangladesh, 88 adults, and 79 children (8–10 years) were randomized to receive either a single oral dose of 1 × 104, 1 × 105 or 1 × 106 CFU of SC602 (a live, attenuated Shigella flexneri 2a strain vaccine) or placebo. In the adult outpatient 1 × 106 CFU group, severe joint pain and body aches were reported by one and two vaccinees respectively. In the adult inpatient trial, SC602 was isolated from 3 volunteers, pre-vaccination antibody titers were high, and fourfold increases in serum IgG anti-LPS responses were observed in 2 of 5 subjects of the 1 × 106 CFU group. None of the volunteers developed diarrhea. Overall, SC602 was found to be associated with minimal vaccine shedding, minimal reactogenicity, no transmission risk, and low immune stimulation.

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Vaccine

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29

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6

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Biological sciences

Microbiology not elsewhere classified

Agricultural, veterinary and food sciences

Biomedical and clinical sciences

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