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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
Safety and immunogenicity of SC599, an oral live attenuated Shigella dysenteriae type-1 vaccine in healthy volunteers: Results of a Phase 2, randomized, double-blind placebo-controlled trial
Vaccine, Volume 27, No. 8, Year 2009
Notification
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Description
SC599 vaccine is a live Shigella dysenteriae 1 strain attenuated by deletion of invasion [icsA], iron chelation [ent, fep] and shiga toxin A subunit [stxA] genes. In a preliminary Phase 1 single dose prospective study, we showed that SC599 vaccine was well tolerated, and the maximum tolerable dose was greater than 108 CFU [Sadorge C, Ndiaye A, Beveridge N, Frazer S, Giemza R, Jolly N, et al. Phase 1 clinical trial of live attenuated Shigella dysenteriae type-1 ΔicsA Δent Δfep ΔstxA:HgR oral vaccine SC599 in healthy human adult volunteers. Vaccine 2008; 26(7):978-8]. In this Phase 2 trial, three groups of volunteers ingested a single dose of SC599 [105 CFU, n = 38; 107 CFU, n = 36] or placebo [n = 37]. Both 105 and 107 CFU doses were immunogenic, inducing significant IgA and IgG LPS-specific ASCs and antibody responses, comparable in magnitude to those of other strains that prevented illness following experimental challenge. In the intention to treat analysis, 34.2% and 44.4% IgA ASC responders were detected in the 105 and 107 CFU groups respectively (p < 0001 vs placebo for both groups), as well as 31.6% and 33.3% serum IgA responders (p < 001 and p < 0.001 vs placebo for 105 and 107 CFU groups, respectively). No difference between the two vaccine groups was observed. No stxB-specific antibody response was detected in the vaccines. SC599 excretion occurred in 23.7 and 30.6% of subjects in the 105 and 107 CFU groups, respectively. SC599 vaccine was well tolerated, and the reported adverse events were mainly digestive. These results indicate that a single oral immunization of SC599 vaccine elicits a significant circulating IgA ASC and serum antibody response that may confer protection against the most severe symptoms of Shigellosis in responders to the vaccine. © 2009 Elsevier Ltd. All rights reserved.
Authors & Co-Authors
Launay, Odile
France, Paris
Ap-hp Assistance Publique - Hopitaux de Paris
Sadorge, Christine
France, Paris
Institut Pasteur, Paris
Jolly, Nathalie
France, Paris
Institut Pasteur, Paris
Poirier, Béatrice
France, Paris
Institut Pasteur, Paris
Seffer, Valérie
France, Paris
Institut Pasteur, Paris
Johnson, Julie D.
United Kingdom, London
St George’s, University of London
Vray, Muriel M.
France, Paris
Institut Pasteur, Paris
Sansonetti, Philippe Jean
France, Paris
Inserm
Poyart, Claire
France, Paris
Ap-hp Assistance Publique - Hopitaux de Paris
Lewis, David J.M.
United Kingdom, London
St George’s, University of London
Gougeon, Marie Lise
France, Paris
Institut Pasteur, Paris
Statistics
Citations: 32
Authors: 11
Affiliations: 4
Identifiers
Doi:
10.1016/j.vaccine.2008.12.021
ISSN:
0264410X
Research Areas
Disability
Health System And Policy
Maternal And Child Health
Study Design
Cohort Study