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首页> 外文期刊>Infection and immunity >Phase 2 Clinical Trial of AttenuatedSalmonella enterica Serovar Typhi Oral Live Vector Vaccine CVD 908-htrA in U.S. Volunteers
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Phase 2 Clinical Trial of AttenuatedSalmonella enterica Serovar Typhi Oral Live Vector Vaccine CVD 908-htrA in U.S. Volunteers

机译：减毒小肠沙门氏菌血清型鼠伤风口服活载体疫苗CVD 908-htrA在美国志愿者中的2期临床试验

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Salmonella enterica serovar Typhi strain CVD 908-htrA is a live attenuated strain which may be useful as an improved oral typhoid vaccine and as a vector for cloned genes of other pathogens. We conducted a phase 2 trial in which 80 healthy adults received one of two dosage levels of CVD 908-htrA in a double-blind, placebo-controlled, crossover study. There were no differences in the rates of side effects among volunteers who received high-dose vaccine (4.5 × 108 CFU), lower-dose vaccine (5 × 107 CFU), or placebo in the 21 days after vaccination, although recipients of high-dose vaccine (8%) had more frequent diarrhea than placebo recipients (0%) in the first 7 days. Seventy-seven percent and 46% of recipients of high- and lower-dose vaccines, respectively, briefly excreted vaccine organisms in their stools. All blood cultures were negative. Antibody-secreting cells producing antilipopolysaccharide (LPS) immunoglobulin A (IgA) were detected in 100 and 92% of recipients of high- and lower-dose vaccines, respectively. Almost half the volunteers developed serum anti-LPS IgG. Lymphocyte proliferation and gamma interferon production against serovar Typhi antigens occurred in a significant proportion of vaccinees. This phase 2 study supports the further development of CVD 908-htrA as a single-dose vaccine against typhoid fever and as a possible live vector for oral delivery of other vaccine antigens.
机译：肠炎沙门氏菌伤寒沙门氏菌CVD 908-htrA是减毒活株，可用作改良的口腔伤寒疫苗和其他病原体克隆基因的载体。我们进行了一项2期试验，其中80名健康成年人在一项双盲，安慰剂对照，交叉研究中接受了CVD 908-htrA两种剂量水平之一。接受高剂量疫苗（4.5×108 CFU），低剂量疫苗（5×107 CFU）或安慰剂的志愿者在接种疫苗后的21天之内的副作用发生率没有差异，尽管在开始的7天内，比起安慰剂接受者（0 ％），高剂量疫苗（8％）的腹泻频率更高。高剂量和低剂量疫苗的接受者分别有77％和46％短暂地排泄了粪便中的疫苗生物。所有血液培养均为阴性。分别在100和92％的高剂量和低剂量疫苗接种者中检测到产生抗脂多糖（LPS）免疫球蛋白A（IgA）的抗体分泌细胞。几乎一半的志愿者开发了血清抗LPS IgG。抗血清型伤寒抗原的淋巴细胞增殖和γ干扰素产生的比例很大。这项2期研究支持CVD 908-htrA的进一步开发，将其作为针对伤寒的单剂量疫苗，以及作为口服递送其他疫苗抗原的可能的活载体。

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