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
File version
Author(s)
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.
Griffith University Author(s)
Primary Supervisor
Other Supervisors
Editor(s)
Date
Size
File type(s)
Location
License
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.
Journal Title
Vaccine
Conference Title
Book Title
Edition
Volume
29
Issue
6
Thesis Type
Degree Program
School
Publisher link
Patent number
Funder(s)
Grant identifier(s)
Rights Statement
Rights Statement
Item Access Status
Note
Access the data
Related item(s)
Subject
Biological sciences
Microbiology not elsewhere classified
Agricultural, veterinary and food sciences
Biomedical and clinical sciences