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Age-related efficacy of Shigella O-specific polysaccharide conjugates in 1-4-year-old Israeli children.

Abstract：

BACKGROUND:Despite its high worldwide morbidity and mortality, there is yet no licensed vaccine for shigellosis. We reported the safety and immunogenicity of Shigella O-specific polysaccharide-protein conjugates in adults and young children and efficacy of Shigella sonnei conjugate in young adults. METHODS:A double-blinded, randomized and vaccine-controlled Phase 3 evaluation of S. sonnei and Shigella flexneri 2a O-SP-rEPA conjugates, 25 microg, injected IM twice, 6 weeks apart, into healthy 1-4 years old, is reported. The children were followed for 2 years by telephone every other week and stool cultures were obtained for each episode of acute diarrhea (> or =3 loose stools/day or a bloody/mucous stool). Sera were taken randomly from 10% of the participants for IgG anti-LPS and anti-carrier levels. RESULTS:Of the 2799 enrollees, 1433 received S. sonnei and 1366 S. flexneri 2a conjugates; 2699 (96.4%) completed the 2-year follow-up. Local reactions occurred in approximately 5% and approximately 4% had temperatures > or =38.0 degrees C lasting 1-2 days. There were no serious adverse events attributable to the vaccines. Of the 3295 stool cultures obtained, 125 yielded S. sonnei and 21 S. flexneri 2a. Immunogenicity and efficacy were age-related. The overall efficacy of the S. sonnei conjugate was 27.5%; 71.1% (P=0.043) in the 3-4 years old. The numbers for S. flexneri 2a were too few for meaningful analysis. Cross-protection by S. flexneri 2a for non-vaccine S. flexneri types was found, but the numbers were too few for statistical significance. There was an age-related rise of vaccine-specific IgG anti-LPS in both groups, peaking at about 10 weeks and declining thereafter, but remaining > or =4-fold higher than in the controls 2 years after the second dose. CONCLUSIONS:Shigella conjugates are safe and immunogenic in 1-4 years old. The S. sonnei conjugate elicited 71.1% efficacy in the 3-4 years old and can be predicted to be efficacious in individuals older than 3 years of age. These results urge studies with our improved conjugates.

journal_name

Vaccine

journal_title

Vaccine

authors

Passwell JH,Ashkenazi S,Banet-Levi Y,Ramon-Saraf R,Farzam N,Lerner-Geva L,Even-Nir H,Yerushalmi B,Chu C,Shiloach J,Robbins JB,Schneerson R,Israeli Shigella Study Group.

doi

10.1016/j.vaccine.2009.12.050

subject

Has Abstract

pub_date

2010-03-02 00:00:00

pages

2231-2235

issue

eissn

0264-410X

issn

1873-2518

pii

S0264-410X(09)01960-4

journal_volume

pub_type

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Age-related efficacy of Shigella O-specific polysaccharide conjugates in 1-4-year-old Israeli children.