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目的:评价变更后流感毒株生产的国产流感裂解疫苗安全性和免疫原性。方法:对宁波市宁海县559例分组接种流感裂解疫苗者进行临床指标(局部反应、全身反应)的监测,并抽取其中213例,用流感病毒HI抗体测定法对接种者免疫前后的抗体滴度进行测定,比较免疫前后抗体阳转率及几何平均滴度(GMT)。结果:观察对象接种疫苗后发热反应发生率为1.22%,全身其他反应发生率为1.22%,局部反应发生率为1.07%,且以轻度反应为主。H1N1型、H3N2型、B型免后抗体阳转率分别为84.04%、85.45%、83.57%;不同年龄组免后抗体滴度的增长倍数,H1N1型在5.50～16.00倍之间,H3N2型在13.16～39.33倍之间,B型在7.28～24.85倍之间,各年龄组各抗体型别免疫前后GMT差别均有统计学意义。结论:国产流感裂解疫苗具有良好的安全性和免疫原性。
OBJECTIVE: To evaluate the safety and immunogenicity of a domestic influenza split vaccine produced by a modified influenza strain. Methods: A total of 559 patients in Ninghai County, Ningbo were enrolled in this study. Clinical indexes (local reactions and systemic reactions) were monitored and 213 cases were selected. Antibody titers before and after vaccination were measured by using HI antibody assay The determination of antibody positive rate before and after immunization and geometric mean titer (GMT). Results: The incidence of fever was 1.22% after vaccination. The incidence of other reactions was 1.22%. The incidence of local reactions was 1.07%. The mild reactions were the most common. The positive rates of H1N1, H3N2 and B antibody-free antibody were 84.04%, 85.45% and 83.57% respectively. The antibody titers of H1N1 in different age groups were between 5.50 and 16.00 folds, 13.16 to 39.33 times, B between 7.28 to 24.85 times, the antibody types of all age groups before and after immunization GMT differences were statistically significant. Conclusion: Domestic flu splitting vaccine has good safety and immunogenicity.