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
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
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DOI：
10.1016/j.vaccine.2008.12.021
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发表时间：
2009-02-18
期刊：
影响因子：
5.5
通讯作者：
Gougeon, Marie-Lise
中科院分区：
文献类型：
--
作者：
Launay, Odile;Sadorge, Christine;Gougeon, Marie-Lise
SC599疫苗是一种志贺氏痢疾杆菌1型活菌株，通过缺失侵袭性[icsA]、铁螯合[ent， fep]和志贺毒素a亚基[stxA]基因而减毒。在初步的一期单剂量前瞻性研究中，我们发现SC599疫苗耐受性良好，最大耐受剂量大于10(8)CFU [Sadorge C, Ndiaye a, Beveridge N, Frazer S, Giemza R, jolly N，等]。1型减毒志贺氏痢疾杆菌δ icsA δ ent δ fep δ stxA:HgR口服疫苗SC599在健康成人志愿者中的临床试验疫苗2008;26(7): 978 - 8]。在这项ii期试验中，三组志愿者摄入单剂量SC599 [10(5) CFU, n = 38；10(7) CFU, n = 36]或安慰剂[n = 37]。10(5)和10(7)CFU剂量均具有免疫原性，诱导了显著的IgA和IgG lps特异性ASCs和抗体反应，其程度与其他菌株在实验攻击后预防疾病的反应相当。在意向治疗分析中，在10(5)和10(7)CFU组中分别检测到34.2%和44.4%的IgA ASC应答(p
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 10(8) CFU [Sadorge C, Ndiaye A, Beveridge N, Frazer S, Giemza R, jolly N, et al. Phase I clinical trial of live attenuated Shigella dysenteriae type-1 Delta icsA Delta ent Delta fep Delta stxA: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 [10(5) CFU, n = 38; 10(7) CFU, n = 36] or placebo [n = 37]. Both 10(5) and 10(7) 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 10(5) and 10(7) CFU groups respectively (p