营养缺陷型大肠杆菌K-12-福氏志贺菌2a杂交候选疫苗EcSf2a-2的安全性和免疫原性门诊研究。

Outpatient studies of the safety and immunogenicity of an auxotrophic Escherichia coli K-12-Shigella flexneri 2a hybrid vaccine candidate, EcSf2a-2.

作者信息

Taylor D N, Phillip D F, Zapor M, Trofa A, Van de Verg L, Hartman A, Bendiuk N, Newland J W, Formal S B, Sadoff J C

机构信息

Department of Enteric Infections, Walter Reed Army Institute of Research, Washington, DC 20307-5100.

出版信息

Vaccine. 1994 May;12(6):565-8. doi: 10.1016/0264-410x(94)90318-2.

DOI:10.1016/0264-410x(94)90318-2

PMID:8036831

Abstract

A phase II study was conducted in 244 volunteers at Fort Ord, CA, to determine the safety and immunogenicity of EcSf2a-2, a live, oral Shigella vaccine constructed by transfer of genes from Shigella flexneri to Escherichia coli K-12. In this placebo-controlled study, four doses of vaccine ranging from 2.3 to 9.0 x 10(8) colony-forming units were given on days 0, 3, 14 and 17. Vaccine shedding occurred from 1 to 3 days after each dose. The vaccine was well tolerated at every dose tested. Significant levels of IgA, IgG or IgM antibody-secreting cells (ASC) recognizing S. flexneri 2a lipopolysaccharide (LPS) were found in 94% of a volunteer subset tested 7 days after the first dose of EcSf2a-2. Seven days after the third dose, ASC were detected less often (57%), and were mainly IgA. Significant rises in serum antibody to LPS were detected in 37% of vaccine recipients.

摘要

在加利福尼亚州奥德堡的244名志愿者中进行了一项II期研究，以确定EcSf2a - 2（一种通过将弗氏志贺氏菌的基因转移到大肠杆菌K - 12构建的口服活志贺氏菌疫苗）的安全性和免疫原性。在这项安慰剂对照研究中，在第0、3、14和17天给予四剂剂量范围为2.3至9.0×10⁸菌落形成单位的疫苗。每次接种疫苗后1至3天出现疫苗排出。在测试的每一个剂量下，疫苗的耐受性都良好。在第一剂EcSf2a - 2接种7天后测试的一个志愿者亚组中，94%的人发现有显著水平的识别弗氏志贺氏菌2a脂多糖（LPS）的IgA、IgG或IgM抗体分泌细胞（ASC）。第三剂接种7天后，ASC的检测频率较低（57%），且主要是IgA。37%的疫苗接种者血清中针对LPS的抗体显著升高。