Olin P, Romanus V, Storsaeter J
Department of Paediatrics, Karolinska Institute, Sachs' Children's Hospital, Stockholm, Sweden.
Tokai J Exp Clin Med. 1988;13 Suppl:143-4.
During a placebo controlled trial of acellular pertussis vaccines a cluster of invasive bacterial infections with fatal outcome occurred among vaccinated children as compared with unvaccinated Swedish children of the same birth cohort (4). Clinical and immunological studies did not support the hypothesis of an immunosuppressive effect of the vaccines, which would explain the deaths, but the hypothesis could not be refuted by the data. To evaluate the safety of acellular pertussis vaccines regarding rare severe events--in particular invasive infectious diseases--prospective studies seem to be needed, comparing very large groups. A coordinated and controlled vaccine programme during 1-2 years in most of Sweden combined with national reports of invasive infections may serve as a basis for such a study. A possible study design is given below.
在一项无细胞百日咳疫苗的安慰剂对照试验中，与同一出生队列中未接种疫苗的瑞典儿童相比，接种疫苗的儿童中出现了一组具有致命后果的侵袭性细菌感染（4）。临床和免疫学研究不支持疫苗具有免疫抑制作用从而导致死亡的假说，但该数据也无法反驳这一假说。为了评估无细胞百日咳疫苗在罕见严重事件（特别是侵袭性传染病）方面的安全性，似乎需要进行前瞻性研究，比较非常大的群体。瑞典大部分地区在1 - 2年内实施的协调且可控的疫苗接种计划，再加上侵袭性感染的国家报告，可作为此类研究的基础。下面给出了一种可能的研究设计。
