Scheifele D W, Halperin S A, Ferguson A C
Vaccine Evaluation Center, BC's Children's Hospital, 4500 Oak Street and the University of British Columbia, BC, V6H 3V4, Vancouver, Canada.
Vaccine. 2001 Sep 14;19(32):4720-6. doi: 10.1016/s0264-410x(01)00230-4.
Recent reports indicate that children receiving a fifth consecutive dose of DTPa vaccine have a moderate likelihood of developing a large injection site reaction, the etiology of which remains unknown. We assessed the frequency, severity and outcome of local reactions in 205 children who had participated in earlier studies of DTPa-based vaccines and were due for a fifth dose at 4-6 years. DTPa.IPV vaccine was given intramuscularly in the deltoid. To explore the role of cell-mediated immunity in local reactions we applied epicutaneous (patch) tests at the same visit, using code-labeled solutions of DTPa.IPV, DT, Pa, IPV, alum solution and saline, leaving them in place for 48 h. Subjects were assessed by research staff on the following day. Injection site redness or swelling >/=50 mm diameter was present in 24.4 and 20.5%, respectively, but none of the subjects had fever or persistent limitation of arm movement. Large local reactions were more common in bigger children (P<0.01) but not in those with allergy/atopy. Large reactions resolved within 14 days. Positive skin tests (erythema) occurred at 85 test sites in 51 of 187 evaluable children, principally with DTPa.IPV, IPV and alum solutions. However, only DT and Pa solutions caused positive tests significantly more often in children with injection site redness > or =50 mm than in non-reactors (P < 0.05, odds ratios 5.2 and 6.1, respectively). Presence of alum in most test solutions might have confounded the results as it caused non-specific inflammation when applied alone. We conclude that local reactions to a fifth dose of DTPa-type vaccine are frequent and sometimes extensive but not incapacitating and that concurrent skin testing has potential to identify the vaccine antigens and immune mechanism contributing to local reactions with more refinement of the method.
近期报告显示，连续第五剂次接种白喉破伤风无细胞百日咳疫苗（DTPa）的儿童出现严重注射部位反应的可能性中等，但其病因尚不清楚。我们评估了205名曾参与基于DTPa疫苗早期研究且即将在4至6岁接种第五剂疫苗的儿童局部反应的频率、严重程度及转归。DTPa-IPV疫苗通过肌内注射接种于三角肌。为探究细胞介导免疫在局部反应中的作用，我们在此次访视时采用了皮内（贴片）试验，使用带有编码标签的DTPa-IPV、白喉破伤风联合疫苗（DT）、百日咳杆菌疫苗（Pa）、脊髓灰质炎灭活疫苗（IPV）、明矾溶液和生理盐水溶液，使其在皮肤上保留48小时。研究人员在次日对受试者进行评估。注射部位发红或肿胀直径≥50mm的发生率分别为24.4%和20.5%，但所有受试者均未出现发热或手臂活动持续受限的情况。较大儿童出现严重局部反应更为常见（P<0.01），但在有过敏/特应性体质的儿童中并非如此。严重反应在14天内消退。在187名可评估儿童中的51名儿童的85个试验部位出现了阳性皮肤试验（红斑），主要针对DTPa-IPV、IPV和明矾溶液。然而，只有DT和Pa溶液在注射部位发红≥50mm的儿童中引起阳性试验的频率显著高于未出现反应的儿童（P<0.05，优势比分别为5.2和6.1）。大多数试验溶液中存在明矾可能混淆了结果，因为单独使用时它会引起非特异性炎症。我们得出结论，第五剂次DTPa类疫苗的局部反应较为常见，有时较为严重，但不会导致机体功能丧失，同时皮肤试验有可能更精确地识别导致局部反应的疫苗抗原和免疫机制。
