Stetler H C, Garbe P L, Dwyer D M, Facklam R R, Orenstein W A, West G R, Dudley K J, Bloch A B
Pediatrics. 1985 Feb;75(2):299-303.
Two outbreaks of group A streptococcal abscesses following receipt of diphtheria-tetanus toxoid-pertussis (DTP) vaccine from different manufacturers were reported to the Centers for Disease Control (CDC) in 1982. The clustering of the immunization times of cases, the isolation of the same serotype of Streptococcus from all cases in each outbreak, and the absence of reported abscesses associated with receipt of the same lots of vaccine in other regions of the country, suggest that each outbreak was probably caused by contamination of a single 15-dose vial of vaccine. The preservative thimerosal was present within acceptable limits in unopened vials from the same lot of DTP vaccine in each outbreak. Challenge studies indicate that a strain of Streptococcus from one of the patients can survive up to 15 days in DTP vaccine at 4 degrees C. Contamination of vials during manufacturing would have required survival of streptococci for a minimum of 8 months. Preservatives in multidose vaccine vials do not prevent short-term bacterial contamination. Options to prevent further clusters of streptococcal abscesses are discussed. The only feasible and cost-effective preventive measure now available is careful attention to sterile technique when administering vaccine from multidose vials.
1982年,有两起接种来自不同生产商的白喉-破伤风类毒素-百日咳(DTP)疫苗后发生A群链球菌脓肿的疫情报告给了疾病控制中心(CDC)。病例免疫接种时间的聚集性、每次疫情中所有病例均分离出同一血清型的链球菌,以及该国其他地区未报告与接种同一批次疫苗相关的脓肿病例,表明每次疫情可能是由单个15剂量瓶的疫苗污染所致。每次疫情中同一批次DTP疫苗未开封瓶中的防腐剂硫柳汞含量在可接受范围内。挑战研究表明,其中一名患者的一株链球菌在4℃的DTP疫苗中可存活长达15天。生产过程中瓶的污染需要链球菌至少存活8个月。多剂量疫苗瓶中的防腐剂不能防止短期细菌污染。讨论了预防进一步发生链球菌脓肿聚集的措施。目前唯一可行且具有成本效益的预防措施是在从多剂量瓶中接种疫苗时严格注意无菌技术。