Boikos Constantina, Joseph Lawrence, Scheifele David, Lands Larry C, De Serres Gaston, Papenburg Jesse, Winters Nicholas, Chilvers Mark, Quach Caroline
Department of Epidemiology, Biostatistics & Occupational Health, McGill University, Montreal, QC, Canada.
Vaccine Evaluation Center, Child & Family Research Institute, UBC, British Columbia, Canada.
Vaccine. 2017 Sep 5;35(37):5019-5026. doi: 10.1016/j.vaccine.2017.07.068. Epub 2017 Jul 31.
Despite the approved use of live-attenuated intranasal influenza vaccine (LAIV) for seasonal immunization of patients with cystic fibrosis (CF), many questions remain unanswered regarding the timing, duration, and types of adverse events that occur following administration of this vaccine.
In 2012 and 2013, 264 LAIV doses were administered to 198 patients aged 2-19 with CF. Vaccinees were followed prospectively for 55 days after vaccination (day 0) and information on adverse events was collected. Bayesian change-point analysis was used to identify the risk period following LAIV during which participants had a higher risk of reporting adverse events. Multivariable zero-inflated Poisson regression models were then used to estimate the adjusted incidence rate ratio (aIRR) and 95% credible interval (CrI) of reporting each adverse event in the risk period versus the control period.
There was a higher risk of reporting serious adverse events (SAEs) (aIRR 1.45, 95% CrI (0.29, 5.17)) and solicited symptoms during days 0-6 of follow-up compared to control period days 7-55. However, most SAEs were not causally related to LAIV and the solicited symptom episodes were brief, usually lasting 1-2 days. There was no increased risk of antibiotic prescriptions for respiratory conditions in the risk vs. control periods (aIRR 0.48, 95% CrI (0.23, 0.91)).
Adverse events were most common 0-6 days after LAIV administration but were generally benign and self-limiting. Pulmonary exacerbations did not increase in frequency.
尽管减毒活流感鼻内疫苗（LAIV）已被批准用于囊性纤维化（CF）患者的季节性免疫，但关于该疫苗接种后发生的不良事件的时间、持续时间和类型，仍有许多问题未得到解答。
在2012年和2013年，对198名2至19岁的CF患者接种了264剂LAIV。接种疫苗者在接种后（第0天）接受了55天的前瞻性随访，并收集了不良事件的信息。采用贝叶斯变点分析来确定LAIV接种后的风险期，在此期间参与者报告不良事件的风险较高。然后使用多变量零膨胀泊松回归模型来估计风险期与对照期相比报告每种不良事件的调整发病率比（aIRR）和95%可信区间（CrI）。
与对照期的第7至55天相比，随访的第0至6天报告严重不良事件（SAE）（aIRR 1.45，95% CrI（0.29，5.17））和主动报告症状的风险更高。然而，大多数SAE与LAIV无因果关系，主动报告症状的发作很短暂，通常持续1至2天。风险期与对照期相比，呼吸道疾病使用抗生素处方的风险没有增加（aIRR 0.48，95% CrI（0.23，0.91））。
不良事件在LAIV接种后0至6天最为常见，但通常是良性的且为自限性。肺部病情加重的频率没有增加。
