Araújo O O, Forleo-Neto E, Vespa G N, Puccini R F, Weckx L W, Carvalho E S, Farhat C K
Departamento de Pediatria, Universidade Federal de São Paulo/Escola Paulista de Medicina, Rua Loefgreen, 1998, SP, CEP 04040-003, São Paulo, Brazil.
Vaccine. 2000 Sep 15;19(2-3):367-75. doi: 10.1016/s0264-410x(00)00093-1.
This study investigated the immunogenicity and safety of including a Haemophilus influenzae type b vaccine (polyribosylribitol phosphate conjugated to tetanus toxoid, PRP-T) in three different vaccination schemes: (1) PRP-T reconstituted with a combined diphtheria-tetanus-pertussis-inactivated poliovirus vaccine (DTP-IPV//PRP-T); (2) PRP-T reconstituted with DTP and administered concomitantly with an oral poliovirus vaccine (DTP//PRP-T+OPV); and (3) PRP-T administered concomitantly with DTP at a different injection site and OPV (DTP+PRP-T+OPV). Vaccines were given at 2, 4, and 6 months of age. A total of 252 infants were enrolled, and randomly assigned to one of the three vaccination groups (84 infants in each group); 241 infants were followed until the end of the study. Antibody production against PRP, diphtheria, tetanus and pertussis antigens was satisfactory for each vaccination scheme used. A good response to Hib vaccine was elicited in each group, and 3 months after the third vaccine dose, at least 97% of children in each group had levels of PRP antibody considered to be seroprotective (>0.15 microg/ml), and over 90% of children in each group had levels over 1. 0 microg/ml. The solicited local and systemic adverse events following vaccination were mild in all groups and resolved within 4 days without medical intervention. With the exception of fever, which was more common after the second dose in children who received DTP-IPV//PRP-T, local and systemic reactions did not differ between the vaccination groups. Due to the practical advantages of combined vaccines, their use in routine immunization programs in developing countries is highly desirable. Our results show that Hib conjugate vaccine can be included in routine immunization programs that include either OPV or IPV with satisfactory immunogenicity and safety profiles. This flexible approach should facilitate the inclusion of the Hib conjugate vaccine in routine immunization programs on a world-wide scale.
本研究调查了在三种不同的疫苗接种方案中纳入b型流感嗜血杆菌疫苗（与破伤风类毒素结合的多聚核糖磷酸，PRP-T）的免疫原性和安全性：（1）用白喉-破伤风-百日咳-灭活脊髓灰质炎病毒联合疫苗（DTP-IPV//PRP-T）重构PRP-T；（2）用DTP重构PRP-T并与口服脊髓灰质炎病毒疫苗同时接种（DTP//PRP-T+OPV）；以及（3）在不同注射部位与DTP和OPV同时接种PRP-T（DTP+PRP-T+OPV）。疫苗在2、4和6月龄时接种。共纳入252名婴儿，并随机分配到三个疫苗接种组之一（每组84名婴儿）；241名婴儿被随访至研究结束。对于所使用的每种疫苗接种方案，针对PRP、白喉、破伤风和百日咳抗原的抗体产生情况令人满意。每组对b型流感嗜血杆菌疫苗均产生了良好反应，在第三次接种疫苗3个月后，每组至少97%的儿童PRP抗体水平被认为具有血清保护作用（>0.15μg/ml），且每组超过90%的儿童抗体水平超过1.0μg/ml。接种疫苗后引起的局部和全身不良事件在所有组中均较轻微，无需医疗干预在4天内即可缓解。除了在接受DTP-IPV//PRP-T的儿童中第二次接种后发热更为常见外，各疫苗接种组的局部和全身反应并无差异。由于联合疫苗具有实际优势，在发展中国家的常规免疫规划中使用联合疫苗非常可取。我们的结果表明，b型流感嗜血杆菌结合疫苗可纳入包含OPV或IPV的常规免疫规划中，且具有令人满意的免疫原性和安全性。这种灵活的方法应有助于在全球范围内将b型流感嗜血杆菌结合疫苗纳入常规免疫规划。
