国产冻干人二倍体细胞狂犬病疫苗预防接种不良事件发生率和影响因素

Incidence of adverse events following immunization with a domestic human diploid cell-based rabies vaccine and factors influencing incidence

目的 分析一种国产冻干人二倍体细胞狂犬病疫苗(Human diploid cell based rabies vaccine, RabV-hdc)预防接种不良事件发生率及其影响因素。方法 选择2018年6月至2020年9月在陕西省13个区县狂犬病暴露预防处置门诊接种RabV-hdc的受试者,观察每剂次接种后0-3d发生的不良事件,分析不良事件发生率和影响因素。结果 共入组31 623例受试者,累计接种148 851剂次RabV-hdc,发生不良事件352例次,总发生率为2.36‰。局部、全身不良事件发生率分别为1.38‰、1.06‰;1级、2级、3级、4级不良事件发生率分别为0.95‰、1.13‰、0.28‰、0.00‰。多因素Logistic回归分析显示,女性受试者不良事件发生率高于男性受试者,0-4岁、5-14岁受试者高于≥60岁受试者,免疫机能低下或过敏体质受试者高于其他受试者,Ⅲ级暴露受试者高于Ⅰ/Ⅱ级暴露受试者[OR(95%CI):1.51(1.19-1.92)、6.49(2.85-14.79)、2.69(1.17-6.20)、6.09(2.64-14.04)和1.81(1.30-2.51)]。结论 本研究RabV-hdc接种后不良事件发生率在预期范围内,以女性、0-14岁人群、免疫机能低下或过敏体质人群和暴露等级Ⅲ级者发生风险高;建议加强RabV-hdc接种后护理。

Objective To explore the incidence of adverse events following immunization with a domestic human diploid cell-based rabies vaccine(RabV-hdc) and its influencing factors.Methods We enrolled individuals with suspected rabies exposure from clinics in 13 districts/counties of Shaanxi province from June 2018 to September 2020 and vaccinated them with RabV-hdc. We observed for adverse events 0-3 days after each dose to determine the incidence and its influencing factors.Results A total of 31 623 subjects were enrolled, and 148 851 doses of RabV-hdc were administered. Adverse events occurred following 352 vaccine doses, for an incidence of 2.36‰. Incidences for local and systemic adverse events were 1.38‰ and 1.06‰;and for grade 1, 2, 3, and 4 adverse events were 0.95‰, 1.13‰, 0.28‰, and 0.00‰, respectively. Multivariate logistic regression showed that the incidence of adverse event was higher among females than males, among 0-4-and 5-14-year-olds than among ≥60-year-olds, among low-immunity or allergic individuals than among others, and among subjects with level Ⅲ exposures than among subjects with level Ⅰ/Ⅱ exposures, respectively [OR(95%CI): 1.51(1.19-1.92), 6.49(2.85-14.79), 2.69(1.17-6.20), 6.09(2.64-14.04), and 1.81(1.30-2.51)].Conclusions The overall incidence of RabV-hdc adverse events was acceptable, and was higher among females, 0-14-year-olds, low-immunity or allergic individuals, and individuals with level Ⅲ exposures. We suggest strengthening post-vaccination healthcare.