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
Kazi Mizanur Rahman, Shams El Arifeen, K. Zaman, Mahbubur Rahman, Rubhana Raqib, Mohammad Yunus, Nazma Begum, Badrul Munir Sohel, Muntasirur Rahman, Malabi Venkatesan, Thomas L. Hale, Daniel W. Isenbargerhttp://academic.research.microsoft.com/io.ashx?type=5&id=49266317&selfId1=0&selfId2=0&maxNumber=12&query=
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 1×106CFU 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 1×106CFU 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.
, vol. 29, no. 6, pp. 1347-1354, 2011