TY - JOUR
T1 - 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
AU - Rahman, Kazi Mizanur
AU - Arifeen, Shams El
AU - Zaman, K.
AU - Rahman, Mahbubur
AU - Raqib, Rubhana
AU - Yunus, Mohammad
AU - Begum, Nazma
AU - Islam, Md Shaheenul
AU - Sohel, Badrul Munir
AU - Rahman, Muntasirur
AU - Venkatesan, Malabi
AU - Hale, Thomas L.
AU - Isenbarger, Daniel W.
AU - Sansonetti, Philippe J.
AU - Black, Robert E.
AU - Baqui, Abdullah H.
N1 - Funding Information:
This research study was funded by Walter Reed Army Institute of Research (WRAIR), USA and National Vaccine Program (NVP), USA . The opinions or assertions contained herein are the private views of the authors, and are not to be construed as official, or as reflecting true views of the Department of the Army or the Department of Defense. The authors are grateful to Dr. David Taylor for his comments and suggestions. ICDDR,B acknowledges with gratitude the commitment of WRAIR and NVP to the Centre's research efforts.
PY - 2011/2/1
Y1 - 2011/2/1
N2 - 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.
AB - 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.
KW - Bangladesh
KW - Randomized controlled trial
KW - SC602
KW - Shigella vaccine
UR - http://www.scopus.com/inward/record.url?scp=78751578966&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=78751578966&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2010.10.035
DO - 10.1016/j.vaccine.2010.10.035
M3 - Article
C2 - 21040694
AN - SCOPUS:78751578966
SN - 0264-410X
VL - 29
SP - 1347
EP - 1354
JO - Vaccine
JF - Vaccine
IS - 6
ER -