ICDDR,B, Mohakhali, Dhaka 1212, Bangladesh.
Vaccine. 2011 Feb 1;29(6):1347-54. doi: 10.1016/j.vaccine.2010.10.035. Epub 2010 Oct 30.
In double-blind trials in Bangladesh, 88 adults, and 79 children (8-10 years) were randomized to receive either a single oral dose of 1 × 10(4), 1 × 10(5) or 1 × 10(6)CFU of SC602 (a live, attenuated Shigella flexneri 2a strain vaccine) or placebo. In the adult outpatient 1 × 10(6) CFU group, severe joint pain and body aches were reported by one and two vaccinees respectively. In the adult inpatient trial, SC602 was isolated from 3 volunteers, pre-vaccination antibody titers were high, and fourfold increases in serum IgG anti-LPS responses were observed in 2 of 5 subjects of the 1 × 10(6)CFU group. None of the volunteers developed diarrhea. Overall, SC602 was found to be associated with minimal vaccine shedding, minimal reactogenicity, no transmission risk, and low immune stimulation.
在孟加拉国进行的双盲试验中，88 名成年人和 79 名儿童（8-10 岁）被随机分为接受单次口服剂量为 1×10(4)、1×10(5)或 1×10(6)CFU 的 SC602（一种活的、减毒的福氏志贺菌 2a 菌株疫苗）或安慰剂。在成人门诊 1×10(6)CFU 组中，分别有一名和两名疫苗接种者报告出现严重关节疼痛和身体疼痛。在成人住院试验中，SC602 从 3 名志愿者中分离出来，接种前抗体滴度较高，5 名 1×10(6)CFU 组中的 2 名志愿者的血清 IgG 抗 LPS 反应呈四倍增加。没有志愿者出现腹泻。总的来说，SC602 与最小的疫苗脱落、最小的反应原性、无传播风险和低免疫刺激有关。
