title: Safety and immunogenicity of Shigella sonnei and Shigella flexneri 2a O-specific polysaccharide conjugates in children.
abstract: O-specific polysaccharide conjugates of shigellae were safe and immunogenic in young adults, and a Shigella sonnei conjugate conferred protection [1-3]. Shigellosis is primarily a disease of children; therefore, the safety and immunogenicity of S. sonnei and Shigella flexneri 2a conjugates were studied in 4- to 7-year-old children. Local and systemic reactions were minimal. The first injection of both conjugates elicited significant rises in geometric mean levels of serum IgG only to the homologous lipopolysaccharide (LPS) (S. sonnei, 0.32-8.25 ELISA units [EU]; S. flexneri 2a, 1.15-20.5 EU; P<.0001). Revaccination at 6 weeks induced a booster response to S. flexneri 2a LPS (20.5-30.5 EU, P=.003). Six months later, the geometric mean levels of IgG anti-LPS for both groups were higher than the prevaccination levels (P<.0001). Similar, but lesser, rises were observed for IgM and IgA anti-LPS. The investigational Shigella conjugates were safe and immunogenic in children and merit evaluation of their efficacy.
authors.affiliation: Division of Infectious Diseases, Department of Pediatrics A, Schneider Children's Medical Center of Israel, Petah Tikva 49202, Israel. shkenazi@post.tau.ac.il
authors.forename: S
authors.initials: S
authors.lastname: Ashkenazi
authors.forename: J H
authors.initials: JH
authors.lastname: Passwell
authors.forename: E
authors.initials: E
authors.lastname: Harlev
authors.forename: D
authors.initials: D
authors.lastname: Miron
authors.forename: R
authors.initials: R
authors.lastname: Dagan
authors.forename: N
authors.initials: N
authors.lastname: Farzan
authors.forename: R
authors.initials: R
authors.lastname: Ramon
authors.forename: F
authors.initials: F
authors.lastname: Majadly
authors.forename: D A
authors.initials: DA
authors.lastname: Bryla
authors.forename: A B
authors.initials: AB
authors.lastname: Karpas
authors.forename: J B
authors.initials: JB
authors.lastname: Robbins
authors.forename: R
authors.initials: R
authors.lastname: Schneerson
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D000918:Antibody Specificity; D001428:Bacterial Vaccines / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004405:Dysentery, Bacillary / Q000517:prevention & control*; D006801:Humans; D018796:Immunoconjugates / Q000009:adverse effects / Q000627:therapeutic use*; D007132:Immunoglobulin Isotypes / Q000097:blood / Q000276:immunology; D019081:O Antigens / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D012760:Shigella / Q000276:immunology*; D012763:Shigella flexneri / Q000276:immunology; D012764:Shigella sonnei / Q000276:immunology; D014611:Vaccination
chemical_list: D000907:Antibodies, Bacterial; D001428:Bacterial Vaccines; D018796:Immunoconjugates; D007132:Immunoglobulin Isotypes; D019081:O Antigens