Jovanović D, Delvaux A M
Dev Biol Stand. 1977;39:105-12.
Reactogenicity and immunogenicity of three recombinant strains, Alice, RIT 4025 and RIT 4050, were re-examined by a retrospective analysis of the data from clinical trials and routine vaccination campaigns. Special emphasis was put on the acceptability of vaccinal strains for the elderly, patients with chronic pulmonary diseases, subjects with atopy and children, as well as on the safety of repeated administrations of the vaccine to the general population. The incidence and nature of postvaccinal symptoms in high risk populations were similar to those observed in healthy subjects. Tolerance of the vaccine by children (2-10 years old) was excellent for both Alice and RIT 4050 strains. At the present time, we have evidence that the vaccine was administered to approximately 2500 subjects without any significant adverse effects, during the course of two or three consecutive vaccination campaigns. This holds true also for 12 vaccinees who received the vaccine for more than three years. The maximal number of doses administered to one person was 14. The vaccinal strains studied have been shown safe and immunogenic both in the general population and in high risk subjects and children.
通过对临床试验和常规疫苗接种活动数据的回顾性分析,重新审视了三种重组菌株Alice、RIT 4025和RIT 4050的反应原性和免疫原性。特别强调了疫苗菌株对老年人、慢性肺部疾病患者、特应性受试者和儿童的可接受性,以及对普通人群重复接种疫苗的安全性。高危人群接种疫苗后症状的发生率和性质与健康受试者中观察到的相似。对于Alice和RIT 4050菌株,2至10岁儿童对疫苗的耐受性极佳。目前,我们有证据表明,在连续两到三次疫苗接种活动过程中,约2500名受试者接种了该疫苗,未出现任何重大不良反应。对于接种疫苗超过三年的12名受种者也是如此。一人接种的最大剂量为14剂。所研究的疫苗菌株在普通人群、高危受试者和儿童中均显示出安全性和免疫原性。