Carlsson R M, Claesson B A, Selstam U, Fagerlund E, Granström M, Blondeau C, Hoffenbach A
Department of Infectious Diseases, Sahlgrenska University Hospital/Ostra, Sweden.
Pediatr Infect Dis J. 1998 Nov;17(11):1026-33. doi: 10.1097/00006454-199811000-00013.
In an open randomized study we compared the safety and immunogenicity of two schedules for priming and booster vaccinations of infants. A pentavalent combination vaccine, including a lyophilized Haemophilus influenzae type b-tetanus toxoid conjugate vaccine reconstituted with a liquid diphtheria, tetanus, acellular pertussis (pertussis toxoid and filamentous hemagglutinin) and inactivated polio vaccine (DTaP-IPV/Act-HIB; Pasteur Mérieux Connaught, Lyon, France) was administered to 236 Swedish infants either at 2, 4 and 6 months or at 3 and 5 months, and a booster dose was administered 7 months after the last primary dose. Adverse events were monitored by diaries for 3 days after each vaccination and by questions at the ensuing visits. Antibodies against the different vaccine components were analyzed after the primary series of vaccinations, before and after the booster injections.
There were no serious adverse reactions, and the rates of febrile events and local reactions were low in both groups. The three dose primary schedule induced higher geometricmean concentrations for all antigens than did the two dose schedule, but there were no differences between the groups in proportions with protective antibody titers against diphtheria, tetanus, Hib and polio or in proportions with certain defined levels of pertussis antibodies. Prebooster results showed a similar pattern, with the exception that the group primed with three injections showed higher proportions of infants with detectable antibodies against polio-virus types 1 and 3. After booster vaccinations there were no differences between the two schedules in geometric mean or in proportions with antibodies above defined antibody concentrations, indicating effective priming from both primary series of vaccinations. Conclusion. The combined vaccine DTaP-IPV/ Act-HIB vaccine was equally safe and immunogenic when administered according to both time schedules studied.
在一项开放性随机研究中，我们比较了两种婴儿初次免疫和加强免疫接种方案的安全性和免疫原性。将一种五价联合疫苗（包括用液体白喉、破伤风、无细胞百日咳（百日咳毒素和丝状血凝素）和灭活脊髓灰质炎疫苗复溶的冻干b型流感嗜血杆菌-破伤风类毒素结合疫苗（DTaP-IPV/Act-HIB；法国里昂巴斯德梅里埃康诺公司））分别于2、4和6月龄或3和5月龄接种给236名瑞典婴儿，并在最后一次初免剂量后7个月给予加强剂量。每次接种后通过日记监测3天的不良事件，并在随后的随访中通过提问进行监测。在初次系列疫苗接种后、加强注射前后分析针对不同疫苗成分的抗体。
两组均未出现严重不良反应，发热事件和局部反应发生率均较低。三剂初免方案诱导的所有抗原几何平均浓度均高于两剂方案，但两组在针对白喉、破伤风、b型流感嗜血杆菌和脊髓灰质炎的保护性抗体滴度比例或特定百日咳抗体水平比例方面无差异。加强免疫前的结果显示出类似的模式，不同的是，接种三剂的组中，可检测到针对1型和3型脊髓灰质炎病毒抗体的婴儿比例更高。加强免疫后，两种方案在几何平均浓度或抗体浓度高于定义浓度的比例方面无差异，表明两种初次系列疫苗接种均能有效进行初免。结论：按照所研究的两种时间表接种DTaP-IPV/Act-HIB联合疫苗时，其安全性和免疫原性相当。
