MEDLINE Journals

    Phase 1 clinical trial of live attenuated Shigella dysenteriae type-1 DeltaicsA Deltaent Deltafep DeltastxA:HgR oral vaccine SC599 in healthy human adult volunteers.

    Authors
    Sadorge C, Ndiaye A, Beveridge N, et al. 
    Institution

    Centre de Recherche Vaccinale et Biomédicale, Institut Pasteur, 75724 Paris Cedex 15, France.

    Source
    Vaccine 2008 Feb 13; 26(7) :978-87.
    Abstract

    Twenty-eight adults received between 10(2) and 10(8)colony forming units of live Shigella dysenteriae type-1 vaccine SC599, attenuated by deletion of invasion (icsA), iron chelation (ent, fep) and shiga toxin A-subunit (stxA) genes, followed by ciprofloxacin on day 4. Dose-independent diarrhea or change in bowel habit was seen in 3 subjects, without dysentery, vaccinaemia or serious adverse events. Hematology and biochemical parameters were unchanged. Doses of 10(5) or greater induced dose-independent SD1 lipopolysaccharide-specific antibody secreting cell (ASC) responses. Geometric mean number of IgA ASCs per 10(6) PBMCs for 10(5), 10(6), 10(7) and 10(8) groups were respectively 41, 8.8, 26 and 8.5. Serum antibody responses were seen in three subjects. SC599 appears immunogenic with maximum tolerated dose greater than 10(8)CFU.

    Mesh
    Administration, Oral
    Adult
    Antibodies, Bacterial
    Bacterial Proteins
    DNA-Binding Proteins
    Dysentery, Bacillary
    Enterobactin
    Female
    Gene Deletion
    Humans
    Male
    Protein Subunits
    Shiga Toxin
    Shigella Vaccines
    Shigella dysenteriae
    Transcription Factors
    Treatment Outcome
    Vaccines, Attenuated
    Language

    eng

    Pub Type(s)
    Clinical Trial, Phase I Journal Article Research Support, Non-U.S. Gov't
    PubMed ID

    18207287

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