Phase 1 clinical trial of live attenuated Shigella dysenteriae type-1 ΔicsA Δent Δfep ΔstxA:HgR oral vaccine SC599 in healthy human adult volunteers

被引：14

作者：

Sadorge, Christine ^{[1
]}

Ndiaye, Anna ^{[1
]}

Beveridge, Nathalie ^{[2
,3
]}

Frazer, Schale ^{[2
,3
]}

Giemza, Rafaela ^{[2
,3
]}

Jolly, Nathalie ^{[1
]}

Johnson, Julie ^{[2
,3
]}

Liddy, Helen ^{[2
,3
]}

Cosgrove, Catherine A. ^{[2
,3
]}

Allavena, Paola ^{[5
]}

Mantovani, Alberto ^{[5
]}

Bechet, Stephane ^{[1
]}

Fontaine-Thompson, Annick ^{[4
]}

Griffin, George E. ^{[2
,3
]}

Dupont, Francis ^{[6
]}

Sansonetti, Philippe J. ^{[4
]}

Lewis, David J. M. ^{[2
,3
]}

机构：

[1] Inst Pasteur, Ctr Rech Vaccinale & Biomed, F-75724 Paris 15, France

[2] St Georges Vaccine Inst, London SW17 0RE, England

[3] St Georges Univ London, Dept Med Microbiol, London SW17 0RE, England

[4] Inst Pasteur, INSERM, Unite Pathogenie Microbienne Mol, Unite 786, F-75724 Paris 15, France

[5] Inst Clin Humanitas, I-20089 Milan, Italy

[6] Henogen SA, B-6041 Charleroi, Belgium

来源：

VACCINE | 2008年 / 26卷 / 07期

关键词：

oral vaccine; Shigella dysenteriae; dysentery;

D O I：

10.1016/j.vaccine.2007.11.024

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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. (c) 2007 Elsevier Ltd. All rights reserved.

引用

页码：978 / 987

页数：10

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