BACKGROUND AND OBJECTIVE: Shigella conjugate vaccines have been shown to be safe, immunogenic and efficacious in adult volunteers. We have now investigated the safety and immunogenicity of investigational @entity14344 and @entity18815 conjugate vaccines in 1- to 4-year-old @entity1 , the age group at greatest risk for @entity6835 . METHODS: The O-specific polysaccharides of @entity14344 and @entity18815 , the two most common shigellae from @entity1 in Israel, were bound to medically useful carrier proteins to form conjugates. Eighty healthy 1- to 4-year-olds were randomized to receive two 0.5-ml im injections 6 weeks apart of either @entity14344 -CRM(9) or @entity18815 -rEPA(succ). Blood was taken before, 6 weeks after the first injection, 4 weeks after the second injections and 2 years after immunization for assay of IgG anti-lipopolysaccharide, @entity7394 toxin and @entity796 exotoxin A antibodies by enzyme-linked immunosorbent assay. RESULTS: During an 8-day surveillance period after each immunization, low fever (37.8-39.0 degrees C) lasting only 24 to 48 h occurred in 2 of 40 recipients after the first injection and 4 of 40 recipients after the second injection of @entity18815 -rEPA(succ) and in 2 of 38 of @entity14344 -CRM(9) after the second injection; no fever was detected after the first injection. Liver function tests were normal in all vaccinees. @entity14344 -CRM(9) elicited a >4-fold rise in IgG anti- @entity558 in 92.1% and @entity18815 -rEPA(succ) in 85% (P < 0.0001) after the second injection; both conjugates elicited type-specific booster responses. At 2 years the geometric mean concentrations of both IgG anti-lipopolysaccharides were significantly higher than preimmunization levels. A >4-fold rise of IgG anti- @entity7394 (65.8%) and IgG anti-ETA (77.5%) was observed. CONCLUSION: These experimental Shigella conjugate vaccines were safe and immunogenic in 1- to 4-year-old @entity1 .

Safety and immunogenicity of @entity14344 -CRM9 and Shigella flexneri type 2a-rEPAsucc conjugate vaccines in one- to four-year-old XXXX .

@entity1 :: ('9606', 'Species') :: ['children', 'patients'] @entity6835 :: ('MESH:D004405', 'Disease') :: ['shigellosis'] @entity558 :: ('MESH:C536528', 'Disease') :: ['LPS'] @entity796 :: ('287', 'Species') :: ['Pseudomonas aeruginosa'] @entity7394 :: ('MESH:D004165', 'Disease') :: ['diphtheria'] @entity14344 :: ('624', 'Species') :: ['Shigella sonnei', 'S. sonnei'] @entity18815 :: ('42897', 'Species') :: ['S. flexneri 2a', 'Shigella flexneri 2a']
@entity1 :: (9606,Species) :: ['children']
