目的:这项研究调查了五价疫苗Gobik(DPT-IPV-b型流感嗜血杆菌[Hib])在年龄≥2和<43个月的健康日本婴儿中的免疫原性和安全性,并同时接种了ActHIB®(Hib)和Tetrabik(DPT-IPV)作为对照。
方法:本研究以3期、多中心、主动控制,评估者盲化,随机化,平行组研究。参与者总共接受了4次皮下剂量(3次初次免疫剂量和一次加强剂量)的实验药物(DPT-IPV-Hib)或活性比较药物(HibDPT-IPV)。主要终点是抗PRP抗体患病率≥1μg/mL,百日咳抗体的患病率,白喉毒素,破伤风毒素,初次免疫后的减毒脊髓灰质炎病毒。
结果:在267名随机参与者中(DPT-IPV-Hib组133人,Hib+DPT-IPV组134人),抗PRP抗体≥1μg/mL时,两组初次免疫后抗体患病率分别为100.0%和88.7%,99.2%和98.5%对白喉毒素,和100.0%和99.2%对破伤风毒素,分别。两组抗百日咳和减毒脊髓灰质炎病毒的抗体患病率均为100.0%。对于所有测量的抗体,验证了DPT-IPV-Hib组对Hib+DPT-IPV组的非劣效性。在这两组中,初次免疫后的所有抗体GMT均高于首次免疫前,加强后的剂量高于初次免疫后的剂量。没有发现安全问题。
结论:单药Gobik,日本批准的第一个DPT-IPV-Hib五价疫苗,被证实同时提供针对Hib感染的初级和加强免疫接种,百日咳,白喉,破伤风,和脊髓灰质炎,并具有与同时接种Hib(ActHIB®)和DPT-IPV四价疫苗(Tetrabik)相当的预防效果和安全性。
OBJECTIVE: This study investigated the immunogenicity and safety of a pentavalent vaccine Gobik (DPT-IPV-Haemophilus influenzae type b [Hib]) in healthy Japanese infants aged ≥ 2 and < 43 months using a concomitant vaccination with ActHIB® (Hib) and Tetrabik (DPT-IPV) as a comparator.
METHODS: This study was conducted as a phase 3, multicenter, active controlled, assessor-blinded, randomized, parallel-group study. Participants received a total of 4 subcutaneous doses (3 primary immunization doses and a booster dose) of either the experimental drug (DPT-IPV-Hib) or the active comparator (Hib + DPT-IPV). The primary endpoints were the anti-PRP antibody prevalence rate with ≥ 1 μg/mL, and the antibody prevalence rates against pertussis, diphtheria toxin, tetanus toxin, and attenuated poliovirus after the primary immunization.
RESULTS: In 267 randomized participants (133 in the DPT-IPV-Hib group and 134 in the Hib + DPT-IPV group), the antibody prevalence rates after the primary immunization in both groups were 100.0 % and 88.7 % for anti-PRP antibody with ≥ 1 μg/mL, 99.2 % and 98.5 % against diphtheria toxin, and 100.0 % and 99.2 % against tetanus toxin, respectively. The antibody prevalence rates against pertussis and attenuated poliovirus were 100.0 % in both groups. The non-inferiority of the DPT-IPV-Hib group to the Hib + DPT-IPV group was verified for all measured antibodies. In both groups, all the GMTs of antibodies after the primary immunization were higher than those before the first dose, and those after the booster dose were higher than those after the primary immunization. No safety issues were identified.
CONCLUSIONS: A single-agent Gobik, the first DPT-IPV-Hib pentavalent vaccine approved in Japan, was confirmed to simultaneously provide primary and booster immunizations against Hib infection, pertussis, diphtheria, tetanus, and poliomyelitis and to have a preventive effect and safety comparable to concomitant vaccination with Hib (ActHIB®) and DPT-IPV quadrivalent vaccine (Tetrabik).