Summary of clinical trials of inactivated influenza vaccine - 1978.
Summary of clinical trials of inactivated influenza vaccine - 1978.
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灭活流感疫苗临床试验总结 - 1978 年。
DOI：
10.1093/clinids/5.4.723
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发表时间：
1983
期刊：
影响因子：
--
通讯作者：
Bozeman,FM
中科院分区：
文献类型：
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作者：
LaMontagne,JR;Noble,GR;Quinnan,GV;Curlin,GT;Blackwelder,WC;Smith,JI;Ennis,FA;Bozeman,FM
本报告总结了1978年进行的A/USSR/77（H1N1）流感疫苗的临床试验。共有2，091例受试者参加了这些试验。这些临床试验的结果表明，需要两剂H1N1病毒抗原才能在80%或更多的25岁以下的受试者中产生血凝素抑制（HAI）抗体的血清滴度>1：40，这些受试者在H1N1病毒流行的早期（1947-1957）不太可能经历过自然感染。仅需要一剂A/Texas/77（H3 N2）或B/Hong Kong/72抗原来刺激血清中HAI抗体的等效滴度。因此，先前自然接触H1N1病毒使26岁或26岁以上的个体对H1N1抗原产生反应。在全病毒和裂解病毒疫苗之间未观察到抗原性的重大差异。当比较疫苗类型时，未观察到测量全身反应的反应指数存在差异。只有一种疫苗的反应指数明显高于安慰剂。观察到的相对一致的抗体反应归因于1976年临床试验后引入的疫苗标准化的新方法。在这些试验中，没有发现与疫苗相关的神经系统问题，包括格林-巴利综合征。含有7-21 μg每种病毒抗原的疫苗具有抗原性，并且耐受性良好。
This report summarizes the clinical trials of the A/USSR/77 (H1N1) influenza vaccines performed in 1978. A total of 2,091 subjects participated in these trials. The results of these clinical trials indicated that two doses of H1N1 viral antigen were necessary to produce serum titers of hemagglutinin-inhibiting (HAI) antibody of >1:40 in 80% or more of the test subjects younger than 25 years of age, who were unlikely to have experienced natural infection during the earlier period of prevalence of H1N1 virus (1947-1957). Only one dose of the A/Texas/77 (H3N2) or B/Hong Kong/72 antigen was necessary to stimulate equivalent titers of HAI antibody in serum. Thus, previous natural exposure to H1N1 viruses primed individuals 26 years of age or older to respond to H1N1 antigens. No major differences in antigenicity were noted between whole-virus and split-virus vaccines. No differences in reaction indexes measuring systemic reactions were noted when vaccine types were compared. Only one vaccine was associated with a reaction index appreciably higher than that of placebo. The relatively uniform antibody responses observed were attributed to the newer methods of vaccine standardization introduced after the clinical trials in 1976. No cases of vaccine-related neurological problems, including Guillain-Barré syndrome, were found during these trials. Vaccines containing 7-21 μg of each viral antigen were antigenic and were well tolerated.