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

Sadorge C; Ndiaye A; Beveridge N; Frazer S; Giemza R; Jolly N; Johnson J; Liddy H; Cosgrove CA; Allavena P; Mantovani A; Bechet S; Fontaine-Thompson A; Griffin GE

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

机译：减毒痢疾志贺氏菌1型减毒活的1期临床试验DeltaicsA Deltaent Deltafep DeltastxA：HgR口服疫苗SC599在健康成人志愿者中

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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.

机译：28名成年人接受了1型活痢疾志贺氏菌SC599疫苗的10（2）至10（8）菌落形成单位，其通过侵袭（icsA），铁螯合（ent，fep）和志贺毒素A亚基的缺失而减弱（stxA）基因，然后在第4天进行环丙沙星治疗。在3名受试者中观察到剂量依赖性腹泻或排便习惯改变，没有痢疾，疫苗血症或严重不良事件。血液学和生化参数不变。 10（5）或更高剂量可诱导剂量依赖性SD1脂多糖特异性抗体分泌细胞（ASC）反应。 10（5），10（6），10（7）和10（8）组的每10（6）个PBMC IgA ASC的几何平均数分别为41、8.8、26和8.5。在三名受试者中观察到血清抗体应答。 SC599似乎具有免疫原性，最大耐受剂量大于10（8）CFU。

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《Vaccine》 |2008年第7期|共10页
作者
Sadorge C; Ndiaye A; Beveridge N; Frazer S; Giemza R; Jolly N; Johnson J; Liddy H; Cosgrove CA; Allavena P; Mantovani A; Bechet S; Fontaine-Thompson A; Griffin GE;
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中图分类卫生标准、卫生检查、医药管理;
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1. Phase 1 clinical trial of live attenuated Shigella dysenteriae type-1 DeltaicsA Deltaent Deltafep DeltastxA:HgR oral vaccine SC599 in healthy human adult volunteers [J] . Sadorge C, Ndiaye A, Beveridge N, Vaccine . 2008,第7期

机译：减毒痢疾志贺氏菌1型减毒活的1期临床试验DeltaicsA Deltaent Deltafep DeltastxA：HgR口服疫苗SC599在健康成人志愿者中
2. Randomized, Placebo-Controlled, Double-Blind Phase 2 Trial Comparing the Reactogenicity and Immunogenicity of a Single Standard Dose to Those of a High Dose of CVD 103-HgR Live Attenuated Oral Cholera Vaccine, with Shanchol Inactivated Oral Vaccine as an Open-Label Immunologic Comparator [J] . Samba O. Sow, Milagritos D. Tapia, Wilbur H. Chen, Clinical and vaccine immunology: CVI . 2017,第12期

机译：随机，安慰剂对照，双盲2期试验比较单一标准剂量与高剂量CVD 103-HgR活弱化口服霍乱疫苗的反应原性和免疫原性，并使用Shanchol灭活口服疫苗作为开放标签免疫学比较器
3. Phase I Evaluation of ΔvirG Shigella sonnei Live, Attenuated, Oral Vaccine Strain WRSS1 in Healthy Adults [J] . Karen L. Kotloff, David N. Taylor, Marcelo B. Sztein, Infection and immunity . 2002,第4期

机译：健康成人的ΔvirGsonnell sonnei活，减毒口服疫苗株WRSS1一期评估
4. Randomized Placebo-Controlled Double-Blind Phase 2 Trial Comparing the Reactogenicity and Immunogenicity of a Single Standard Dose to Those of a High Dose of CVD 103-HgR Live Attenuated Oral Cholera Vaccine with Shanchol Inactivated Oral Vaccine as an Open-Label Immunologic Comparator [O] . Samba O. Sow, Milagritos D. Tapia, Wilbur H. Chen, 2017

机译：随机安慰剂对照双盲2期试验比较单一标准剂量与高剂量CVD 103-HgR活弱化口服霍乱疫苗的反应原性和免疫原性并使用Shanchol灭活口服疫苗作为开放标签免疫学比较器
5. Randomized, Placebo-Controlled, Double-Blind Phase 2 Trial Comparing the Reactogenicity and Immunogenicity of a Single Standard Dose to Those of a High Dose of CVD 103-HgR Live Attenuated Oral Cholera Vaccine, with Shanchol Inactivated Oral Vaccine as an Open-Label Immunologic Comparator [O] . Samba O. Sow, Milagritos D. Tapia, Wilbur H. Chen, 2017

机译：随机，安慰剂控制，双盲相2试验比较单一标准剂量的反应性和免疫原性与高剂量的CVD 103-HGR活化的口腔胆汁疫苗，用Shanchol灭活口腔疫苗作为开放标签免疫学比较器
6. Antigen-Specific lgA B Memory Cell Responses to Shigella Antigens Elicited in Volunteers Immunized with Live Attenuated Shigella flexneri 2a Oral Vaccine Candidates [R] . Simon, J. K., Maciel, M., Weld, E. D., 2011

机译：抗原特异性lga B记忆细胞对志愿者中引起的志贺氏菌抗原的反应，所述志愿者用活的减毒志贺氏菌2a口服疫苗候选物免疫

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

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