Messina Nicole L, Germano Susie, Bonnici Rhian, Lee Lai-Yang, Daley Andrew J, Bustamante Andrea, Jelfs Peter, Curtis Nigel
Infectious Diseases & Microbiology Research Group, Murdoch Children's Research Institute, Parkville, Australia; Department of Paediatrics, The University of Melbourne, Parkville, Australia.
Infectious Diseases & Microbiology Research Group, Murdoch Children's Research Institute, Parkville, Australia.
Tuberculosis (Edinb). 2018 Jul;111:188-192. doi: 10.1016/j.tube.2018.06.001. Epub 2018 Jun 6.
A recent shortage in supply of Bacille Calmette-Guérin (BCG), the live attenuated vaccine given to protect against tuberculosis (TB) caused major disruption to global vaccination programs. In this study, we assessed whether quantification of viable bacteria, could be used to inform the use of the BCG vaccine beyond its manufacturer-assigned expiration date. The viability of a single batch of BCG-Denmark was tested in three independent laboratories. There was high inter-vial and inter-laboratory variability in viability counts, however all three laboratories detected a decrease in BCG viability over time. Despite this, there was no difference in the rate of BCG scar formation in infants who were vaccinated with this batch of BCG before and after its manufacturer-assigned expiration date. This study demonstrates the potential for using BCG viability counts to guide the use of BCG vaccine beyond the manufacturer-assigned expiration date.
用于预防结核病（TB）的减毒活疫苗卡介苗（BCG）近期供应短缺，这给全球疫苗接种计划带来了重大干扰。在本研究中，我们评估了活菌定量是否可用于指导卡介苗在超出制造商规定的有效期后继续使用。在三个独立实验室中对一批丹麦卡介苗的活力进行了测试。瓶间和实验室间的活力计数存在很大差异，然而所有三个实验室均检测到卡介苗活力随时间下降。尽管如此，接种这批卡介苗的婴儿在制造商规定的有效期之前和之后接种，其卡介苗疤痕形成率并无差异。本研究证明了利用卡介苗活力计数指导卡介苗在超出制造商规定的有效期后继续使用的可能性。
