Safety and immunogenicity of investigational Shigella conjugate vaccines in Israeli volunteers

Safety and immunogenicity of investigational Shigella conjugate vaccines in Israeli volunteers
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DOI:
10.1128/iai.64.10.4074-4077.1996
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发表时间:
1996-10-01
影响因子:
3.1
通讯作者:
Robbins, JB
Robbins, JB
中科院分区:
医学2区
文献类型:
--
作者:
Cohen, D;Ashkenazi, S;Robbins, JB

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在192名以色列士兵中评价了研究缀合物的安全性和免疫原性,所述缀合物由与铜绿假单胞菌重组外蛋白A(rEPA)共价结合的宋内志贺菌和福氏志贺菌2a型的O-特异性多糖组成。注射后14天,90%的S. sonnei-rEPA受体和73 - 77%的S. flexneri-rEPA接受者的血清免疫球蛋白G(IgG)和伊加抗脂多糖增加了4倍或更多,(抗LPS)水平;在2年时,这些仍然高于接种前(P < 0.01),20%的接种者在2周时IgM抗LPS增加了4倍或更多,但在6至12个月时恢复到接种前的水平,IgG是最高和最持久的一类LPS抗体。在第42天再次注射没有提高抗体水平,23名接受S. sonnei-rEPA和13/19例(68%)接受S.结果表明,福氏rEPA疫苗免疫后23名志愿者中有19名(83%)和19名志愿者中有11名(58%)出现明显的IgG抗体分泌细胞应答。sonnei-rEPA和S.在这些数据的基础上,开始在以色列的田间试验中进一步评价志贺氏菌缀合物的保护功效。
The safety and immunogenicity of investigational conjugates, composed of the O-specific polysaccharides of Shigella sonnei and Shigella flexneri type 2a covalently bound to Pseudomonas aeruginosa recombinant exoprotein A (rEPA), were evaluated in 192 Israeli soldiers. None had significant local reactions or fever, Fourteen days after injection, 90% of S. sonnei-rEPA recipients and 73 to 77% of S. flexneri-rEPA recipients had a fourfold or greater increase in serum immunoglobulin G (IgG) and IgA anti-lipopolysaccharide (anti-LPS) levels; at 2 years, these remained higher than at prevaccination (P < 0.01), There was a fourfold or greater increase in IgM anti-LPS in 20% of vaccinees at 2 weeks, but levels returned to prevaccination values at 6 to 12 months, IgG was the highest and most sustained class of LPS antibodies. Reinjection at day 42 did not boost antibody levels, Eighteen of 23 (78%) who received S. sonnei-rEPA and 13 of 19 (68%) who received S. flexneri-rEPA had significant IgA-secreting cell responses, Significant IgG antibody-secreting cell responses were detected in 19 of 23 (83%) and 11 of 19 (58%) volunteers following vaccination with S. sonnei-rEPA and S. flexneri 2a-rEPA, respectively, On the basis of these data, further evaluation of the Shigella conjugates for protective efficacy in field trials in Israel was started.