Oral, inactivated, whole cell enterotoxigenic Escherichia coli plus cholera toxin B subunit vaccine: results of the initial evaluation in children. PRIDE Study Group.
Oral, inactivated, whole cell enterotoxigenic Escherichia coli plus cholera toxin B subunit vaccine: results of the initial evaluation in children. PRIDE Study Group.
复制标题
口服灭活全细胞产肠毒素大肠杆菌加霍乱毒素 B 亚单位疫苗：儿童初步评估结果。
DOI：
10.1086/314543
复制
发表时间：
1999
期刊：
影响因子：
--
通讯作者：
Clemens,JD
中科院分区：
文献类型：
--
作者：
Savarino,SJ;Hall,ER;Bassily,S;Brown,FM;Youssef,F;Wierzba,TF;Peruski,L;El-Masry,NA;Safwat,M;Rao,M;ElMohamady,H;Abu-Elyazeed,R;Naficy,A;Svennerholm,AM;Jertborn,M;Lee,YJ;Clemens,JD
两项随机、双盲试验评估了埃及儿童口服灭活肠致病性大肠杆菌（ETEC）加霍乱毒素B亚单位疫苗的安全性和免疫原性。两剂疫苗或E。对105名6至12岁儿童和97名2至5岁儿童进行了间隔2周的coliK-12。每次给药后监测安全性3天。在免疫前和每次给药后7天收集血液以测量免疫应答。很少有儿童报告给药后症状，治疗组之间的症状频率无差异。大多数接种者对定植因子抗原I（100%，6-12岁; 95%，2-5岁）、大肠杆菌表面抗原2（92%，6-12岁; 83%，2-5岁）和大肠杆菌表面抗原4（93%，6-12岁）有伊加抗体分泌细胞应答。疫苗接种分别使93%和81%的儿童的抗毒素伊加和IgG滴度增加了1.44倍。总之，口服ETEC疫苗在2- 12岁儿童中是安全和免疫原性的，证明了在婴儿中进行进一步评价的合理性。
Two randomized, double-blinded trials assessed the safety and immunogenicity of an oral, killed enterotoxigenicEscherichia coli(ETEC) plus cholera toxin B subunit vaccine in Egyptian children. Two doses of vaccine orE. coliK-12 were given 2 weeks apart to 105 6- to 12-year-olds and 97 2- to 5-year-olds. Safety was monitored for 3 days after each dose. Blood was collected before immunization and 7 days after each dose to measure immune responses. Few children reported postdosing symptoms, with no differences in the frequency of symptoms between treatment groups. Most vaccinees had an IgA antibody—secreting cell response against colonization factor antigen I (100%, 6–12 years; 95%, 2–5 years), coli surface antigen 2 (92%, 6–12 years; 83%, 2–5 years), and coli surface antigen 4 (93%, 6–12 years). Vaccination evoked a ⩾4-fold rise in antitoxic IgA and IgG titers in 93% and 81% of children, respectively. In conclusion, the oral ETEC vaccine was safe and immunogenic in 2- to 12-year-old children, justifying further evaluation in infants.