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.
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 × 10(4), 1 × 10(5) or 1 × 10(6)CFU of SC602 (a live, attenuated Shigella flexneri 2a strain vaccine) or placebo. In the adult outpatient 1 × 10(6) 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 × 10(6)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.
ICDDR,B, Mohakhali, Dhaka 1212, Bangladesh. mizan@icddrb.org
Kazi Mizanur
KM
Rahman
Shams El
SE
Arifeen
K
K
Zaman
Mahbubur
M
Rahman
Rubhana
R
Raqib
Mohammad
M
Yunus
Nazma
N
Begum
Md Shaheenul
MS
Islam
Badrul Munir
BM
Sohel
Muntasirur
M
Rahman
Malabi
M
Venkatesan
Thomas L
TL
Hale
Daniel W
DW
Isenbarger
Philippe J
PJ
Sansonetti
Robert E
RE
Black
Abdullah H
AH
Baqui
D000293:Adolescent; D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D018771:Arthralgia / Q000139:chemically induced; D057138:Bacterial Shedding; D001459:Bangladesh; D002648:Child; D004311:Double-Blind Method; D004405:Dysentery, Bacillary / Q000382:microbiology / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008297:Male; D010919:Placebos / Q000008:administration & dosage; D022281:Shigella Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D012763:Shigella flexneri / Q000254:growth & development / Q000276:immunology*; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
D000907:Antibodies, Bacterial; D010919:Placebos; D022281:Shigella Vaccines; D014613:Vaccines, Attenuated