Cohen D, Ashkenazi S, Green M, Lerman Y, Slepon R, Robin G, Orr N, Taylor D N, Sadoff J C, Chu C, Shiloach J, Schneerson R, Robbins J B
Medical Corps, Israel Defence Force and Sackler School of Medicine, Tel Aviv University.
Infect Immun. 1996 Oct;64(10):4074-7. doi: 10.1128/iai.64.10.4074-4077.1996.
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.
对由宋内志贺氏菌和2a型福氏志贺氏菌的O特异性多糖与铜绿假单胞菌重组外蛋白A（rEPA）共价结合而成的实验性结合物的安全性和免疫原性，在192名以色列士兵中进行了评估。无人出现明显的局部反应或发热。注射后14天，90%的接受宋内志贺氏菌-rEPA的受试者和73%至77%的接受福氏志贺氏菌-rEPA的受试者血清免疫球蛋白G（IgG）和抗脂多糖（抗LPS）的IgA水平升高了四倍或更多；在2年时，这些水平仍高于接种前（P<0.01）。20%的接种者在2周时IgM抗LPS水平升高了四倍或更多，但在6至12个月时恢复到接种前水平。IgG是LPS抗体中水平最高且持续时间最长的类别。在第42天再次注射并未提高抗体水平。接受宋内志贺氏菌-rEPA的23人中的18人（78%）和接受福氏志贺氏菌-rEPA的19人中的13人（68%）有显著的分泌IgA细胞反应。分别在接种宋内志贺氏菌-rEPA和福氏志贺氏菌2a-rEPA后，23名志愿者中的19人（83%）和19名志愿者中的11人（58%）检测到显著的分泌IgG抗体细胞反应。基于这些数据，开始在以色列进行现场试验，对志贺氏菌结合物的保护效力作进一步评估。
