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

Christine Sadorge, Anna Ndiaye, Nathalie Beveridge, Schale Frazer, Rafaela Giemza, Nathalie Jolly, Julie Johnson, Helen Liddy, Catherine A Cosgrove, Paola Allavena, Alberto Mantovani, Stéphane Béchet, Annick Fontaine-Thompson, George E Griffin, Francis Dupont, Philippe J Sansonetti, David J M Lewis

Journal: Vaccine 2008;26(7):978-87

PMID: 18207287

Full Text on Elsevier Science View on PubMed

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.

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

DOI: 10.1016/j.vaccine.2007.11.024

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MeSH Terms: 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