PDF(Pubmed)
Abstract：
An accelerated local injection site reaction following Bacille Calmette-Guérin (BCG) vaccination has been associated with underlying active tuberculosis (TB) in high TB-prevalence settings. The clinical significance of this accelerated BCG reaction in individuals without TB symptoms, particularly in low TB-prevalence countries, is unclear. Using safety surveillance data and baseline interferon-gamma release assays (IGRA) within an international randomised trial of BCG vaccination in healthcare workers (the BRACE trial), we aimed to determine the incidence, and investigate for clinical implications, of an accelerated BCG reaction in asymptomatic adults in low and high TB-prevalence settings. An accelerated BCG reaction occurred in 755/1984 (38 %) of BCG-vaccinees. Although more frequently painful, tender, erythematous and/or swollen within the first fourteen days of vaccination, compared with non-accelerated reactions, the majority of injection site reactions were mild and did not meet criteria for an adverse event. Prior mycobacterial exposure, through prior BCG vaccination (OR 2.46, 95%CI 1.93-3.13, p < 0.001) or latent TB infection (OR 4.17, 95%CI 1.16-14.93, p = 0.03), and female sex (OR 1.27, 95%CI 1.03-1.57, p = 0.02), were key determinants for the occurrence of an accelerated BCG reaction. The development of an accelerated local reaction to BCG vaccination in an individual without prior history of BCG vaccination, should prompt consideration of further investigations for potential underlying TB infection.
摘要：
卡介苗（BCG）疫苗接种后加速的局部注射部位反应与高结核病流行背景下的潜在活动性结核病（TB）有关。这种加速的BCG反应在没有结核病症状的个体中的临床意义，特别是在结核病流行率较低的国家，不清楚。使用安全性监测数据和基线干扰素-γ释放测定（IGRA），在医护人员中进行卡介苗接种的国际随机试验（BRACE试验），我们的目的是确定发病率，并调查临床意义，在低和高结核病患病率环境中，无症状成年人的卡介苗反应加速。在755/1984（38％）的BCG疫苗接种者中发生了加速的BCG反应。虽然更经常痛苦，tender,在接种疫苗的前十四天内出现红斑和/或肿胀，与非加速反应相比，大多数注射部位反应轻微,不符合不良事件的标准.先前接触过分枝杆菌，通过先前的卡介苗接种（OR2.46，95CI1.93-3.13，p<0.001）或潜伏性结核感染（OR4.17，95CI1.16-14.93，p=0.03），和女性（OR1.27，95CI1.03-1.57，p=0.02），是卡介苗加速反应发生的关键决定因素。在没有卡介苗接种史的个体中，对卡介苗接种的局部反应加速，应促使考虑进一步调查潜在的潜在潜在结核感染。
