Preliminary Assessment of the Safety and Immunogenicity of a New CTXΦ-Negative, Hemagglutinin/Protease-Defective El Tor Strain as a Cholera Vaccine Candidate

Jorge A. Benítez; Luis García; Anisia Silva; Hilda García; Rafael Fando; Barbara Cedré; Antonio Pérez; Javier Campos; Boris L. Rodríguez; JoséL. Pérez; Tania Valmaseda; Oliver Pérez; Alberto Pérez; Margarita Ramírez; Talena Ledón; Manuel Díaz Jidy; Miriam Lastre; Laura Bravo; Gustavo Sierra

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Preliminary Assessment of the Safety and Immunogenicity of a New CTXΦ-Negative, Hemagglutinin/Protease-Defective El Tor Strain as a Cholera Vaccine Candidate

机译：新型CTXΦ阴性，血凝素/蛋白酶缺陷型El Tor菌株作为霍乱疫苗候选者的安全性和免疫原性的初步评估

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Vibrio cholerae 638 (El Tor, Ogawa), a new CTXΦ-negative hemagglutinin/protease-defective strain that is a cholera vaccine candidate, was examined for safety and immunogenicity in healthy adult volunteers. In a double-blind placebo-controlled study, no significant adverse reactions were observed in volunteers ingesting strain 638. Four volunteers of 42 who ingested strain 638 and 1 of 14 who received placebo experienced loose stools. The strain strongly colonized the human small bowel, as evidenced by its isolation from the stools of 37 of 42 volunteers. V. cholerae 638, at doses ranging from 4 × 107 to 2 × 109 vibrios, elicited significant serum vibriocidal antibody and anti-Ogawa immunoglobulin A antibody secreting cell responses.

机译：在健康成年志愿者中检测了霍乱弧菌（em Tor）霍乱弧菌638（El Tor，Ogawa），这是一种新的CTXΦ阴性血凝素/蛋白酶缺陷型霍乱疫苗候选株，具有安全性和免疫原性。在一项双盲安慰剂对照研究中，在摄入638菌株的志愿者中未观察到明显的不良反应。摄入638菌株的42名志愿者中有4名服用安慰剂，而14名接受安慰剂的1名志愿者出现了稀便。该菌株强烈地定居于人的小肠，这是通过与42名志愿者中的37名粪便分离而证明的。 V。霍乱 638的剂量范围从4×10 7 到2×10 9 弧菌，可引起明显的血清杀弧菌抗体和抗Ogawa免疫球蛋白A抗体分泌细胞回应。 展开▼

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《Infection and immunity》 |1999年第2期|共7页

作者
Jorge A. Benítez; Luis García; Anisia Silva; Hilda García; Rafael Fando; Barbara Cedré; Antonio Pérez; Javier Campos; Boris L. Rodríguez; JoséL. Pérez; Tania Valmaseda; Oliver Pérez; Alberto Pérez; Margarita Ramírez; Talena Ledón; Manuel Díaz Jidy; Miriam Lastre; Laura Bravo; Gustavo Sierra;
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中图分类医学免疫学;

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1. Preliminary assessment of the safety and immunogenicity of live oral cholera vaccine strain CVD 103-HgR in healthy Thai adults. [J] . S Migasena, P Pitisuttitham, B Prayurahong, Infection and immunity . 1989,第11期

机译：对健康泰国成年人中口服活霍乱疫苗株CVD 103-HgR的安全性和免疫原性的初步评估。

2. Randomized, controlled study of the safety and immunogenicity of peru-15, a live attenuated oral vaccine candidate for cholera, in adult volunteers in bangladesh. [J] . Qadri F, Chowdhury MI, Faruque SM, The Journal of Infectious Diseases . 2005,第4期

机译：在孟加拉国的成年志愿者中，对秘鲁霍乱减毒活疫苗进行口服减毒的秘鲁15疫苗的安全性和免疫原性的随机对照研究。

3. Safety and immunogenicity of a glycoprotein E gene-deleted bovine herpesvirus 1 strain as a candidate vaccine strain [J] . Weiss Marcelo, Anziliero Deniz, Martins Mathias, Pesquisa Veterinaria Brasileira . 2016,第11期

机译：糖蛋白E基因缺失的牛疱疹病毒1株作为候选疫苗株的安全性和免疫原性

4. Immunogenicity of live hog cholera vaccine produced by GPE- strain of hog cholera virus [C] . N. Takikawa, S. Ide, K. Saijo, Congress of the International Pig Veterinary Society . 1999

机译：GPE-猪霍乱病毒产生的活猪霍乱疫苗的免疫原性

5. Identification of immunogenic candidate antigens, proteins expressed in vivo, and development of attenuated strains of Flavobacterium psychrophilum for vaccine development [D] . LaFrentz, Benjamin Ryan 2007

机译：鉴定免疫原性候选抗原，体内表达的蛋白质以及开发用于疫苗开发的嗜冷黄杆菌减毒株

6. Preliminary Assessment of the Safety and Immunogenicity of a New CTXΦ-Negative Hemagglutinin/Protease-Defective El Tor Strain as a Cholera Vaccine Candidate [O] . Jorge A. Benítez, Luis García, Anisia Silva, 1999

机译：新型CTXΦ阴性血凝素/蛋白酶缺陷型El Tor菌株作为霍乱疫苗候选者的安全性和免疫原性的初步评估

7. Preliminary Assessment of the Safety and Immunogenicity of a New CTXΦ-Negative, Hemagglutinin/Protease-Defective El Tor Strain as a Cholera Vaccine Candidate [O] . Jorge A. Benítez, Luis García, Anisia Silva, 1999

机译：初步评估新型CTXφ阴性，血凝素/蛋白酶缺陷EL菌株作为霍乱疫苗候选者的安全性和免疫原性

8. Community-Based Assessment of Safety and Immunogenicity of the Whole Cell PlusRecombinant B Subunit (WC/rBS) Oral Cholera Vaccine in Peru [R] . Begue, R. B., Castellares, G., Ruiz, R., 1995

机译：基于社区的秘鲁全细胞加重组B亚单位（WC / rBs）口服霍乱疫苗的安全性和免疫原性评估

1. El Tor型霍乱弧菌疫苗候选株IEM108抗CTXΦ转染的生物安全性试验 [J] . 梁未丽 ,阚飙 ,祁国明 . 中华微生物学和免疫学杂志 . 2003,第007期

1. Immunogenic composition, composition isolated immunogenic, vaccine, method of treatment or prevention of gram negative bacterial disease, the use of the vaccine.Gram negative bacterial strain genetically manipulated, method for preparing immunogenic composition, method to prepare the vaccine.Method of preparing an immunoglobulin for use in the prevention or treatment of infection neisserial, preparation of immunoglobulin, pharmaceutical preparation and use of pharmaceutical preparation. [P] . 外国专利： BR0313100A . 2005-06-21

机译：免疫原性组合物，分离的具有免疫原性的组合物，疫苗，治疗或预防革兰氏阴性细菌疾病的方法，疫苗的使用。基因操作的革兰氏阴性细菌菌株，制备免疫原性组合物的方法，制备疫苗的方法。免疫球蛋白的制备方法用于预防或治疗奈瑟氏菌感染，免疫球蛋白的制备，药物制剂和药物制剂的用途。

2. immunogenic composition or vaccine, genetically engineered gram-negative bacterial strain, methods for treating or preventing infection or disease, for producing an immunogenic composition or vaccine, and for preparing an immunoglobulin, immunoglobulin preparation, and pharmaceutical preparation [P] . 外国专利： BR112012022800A2 . 2018-05-15

机译：免疫原性组合物或疫苗，基因工程革兰氏阴性细菌菌株，治疗或预防感染或疾病，生产免疫原性组合物或疫苗以及制备免疫球蛋白的方法，免疫球蛋白制剂和药物制剂

3. METHOD AND SET FOR DETERMINATION OF CHOLERA TOXIN PRODUCTION AND DIFFERENTIATION OF EPIDEMIOLOGICALLY SIGNIFICANT STRAINS OF CHOLERA VIBRIOS OF CLASSICAL AND EL TOR BIOVARS [P] . 外国专利： RU2611359C1 . 2017-02-21

机译：测定霍乱毒素的产生和鉴别经典和埃尔托生物的霍乱弧菌的流行病学重要菌株的方法和装置

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Preliminary Assessment of the Safety and Immunogenicity of a New CTXΦ-Negative, Hemagglutinin/Protease-Defective El Tor Strain as a Cholera Vaccine Candidate

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