霍乱活口服疫苗株CVD 103-HgR在泰国健康成年人中的安全性和免疫原性的初步评估。
Preliminary assessment of the safety and immunogenicity of live oral cholera vaccine strain CVD 103-HgR in healthy Thai adults.
作者信息
Migasena S, Pitisuttitham P, Prayurahong B, Suntharasamai P, Supanaranond W, Desakorn V, Vongsthongsri U, Tall B, Ketley J, Losonsky G
机构信息
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
出版信息
Infect Immun. 1989 Nov;57(11):3261-4. doi: 10.1128/iai.57.11.3261-3264.1989.
Abstract
A single dose (5 x 10(8) organisms) of attenuated A- B+ Vibrio cholerae classical Inaba recombinant vaccine strain CVD 103-HgR or placebo was administered to 24 healthy young Thai adults in a randomized, placebo-controlled, double-blind trial of safety and immunogenicity. None of the volunteers experienced untoward reactions. The vaccine strain was recovered from 2 of 12 vaccines. The vibriocidal antibody response (the best immunological correlate of protection) was good: 11 of 12 vaccinees (92%) manifested significant serotype-homologous Inaba antibody rises with a peak reciprocal geometric mean titer (RGMT) postvaccination of 3,417; 9 of 12 exhibited significant serotype-heterologous Ogawa antibody rises (prevaccination RGMT, 180; peak RGMT, 2,874). Nine of 12 vaccinees had significant rises in serum antitoxin. None of the controls exhibited rises in vibriocidal or antitoxic antibody. This preliminary study further confirms the safety and immunogenicity of CVD 103-HgR live oral cholera vaccine and paves the way for larger community studies of this candidate cholera vaccine.
摘要
在一项关于安全性和免疫原性的随机、安慰剂对照、双盲试验中，24名健康的泰国年轻成年人被给予单剂量（5×10⁸个菌）的减毒A - B⁺型霍乱弧菌古典型稻叶重组疫苗株CVD 103 - HgR或安慰剂。没有志愿者出现不良反应。从12份疫苗中的2份中分离出了疫苗株。杀弧菌抗体反应（保护作用的最佳免疫学关联指标）良好：12名接种疫苗者中有11名（92%）出现了血清型同源稻叶抗体显著升高，接种疫苗后几何平均滴度峰值倒数（RGMT）为3417；12名中有9名出现了血清型异源小川抗体显著升高（接种前RGMT为180，峰值RGMT为2874）。12名接种疫苗者中有9名血清抗毒素显著升高。对照组中没有出现杀弧菌或抗毒素抗体升高的情况。这项初步研究进一步证实了CVD 103 - HgR口服活霍乱疫苗的安全性和免疫原性，并为对该候选霍乱疫苗进行更大规模的社区研究铺平了道路。
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