背景:多剂量萨宾毒株灭活脊髓灰质炎病毒疫苗(sIPV)具有显着帮助根除脊髓灰质炎的潜力,特别是在低收入和中等收入国家。作为III期临床试验的一部分,在该临床试验中,婴儿在2、3和4个月大时接受了三剂初次免疫接种,这项研究旨在评估初次免疫后的免疫持久性,以及在18个月大的婴儿中加强5剂量sIPV的安全性和免疫原性。
方法:18个月大的婴儿在第一阶段给予一次加强剂量的5剂量sIPV,这是开放标签。在完成初次免疫后,对第二阶段进行了脱盲,这是随机的,失明,并得到控制;测试组I-III中18个月的婴儿,IPV组,单剂量sIPV组给予一次加强剂量的5剂量sIPV,常规IPV,和单剂量sIPV,分别,在第二阶段。
结果:这项研究包括免疫持久性和安全性集中的1438名婴儿和按方案加强集中的1387名婴儿。初次免疫后14个月,1-3型的血清阳性率(≥1:8)为100%,99.88%,和99.53%在5-剂量sIPV组;100%,98.97%,IPV组为97.23%;99.66%,100%,单剂量sIPV组为99.66%。加强免疫后总共30天,所有组中3种血清型的血清阳性率(≥1:8)达到100%。5剂量sIPV组中1-3型中和抗体的几何平均滴度为9962.89、10273和7870.21,与加强前水平相比,几何平均增加了15.76、33.15和24.5。不良反应总发生率为8.97%,发烧是最常见的,以7.1%的比率观察到,5.52%,5剂量sIPV中的7.96%,IPV,和单剂量组,分别(p=0.4845)。
结论:5剂量sIPV在加强免疫后显示出有希望的免疫持久性和强大的免疫反应,再加上可接受的安全性。
BACKGROUND: The multidose Sabin-strain inactivated poliovirus vaccine (sIPV) has the potential to significantly aid in the eradication of poliomyelitis, particularly in low- and middle-income countries. As part of a phase III clinical trial in which infants were given three doses of primary immunization at 2, 3, and 4 months of age, this study aimed to evaluate immune persistence following primary immunization, as well as the safety and immunogenicity of a booster of the 5-dose sIPV in infants aged 18 months.
METHODS: Infants aged 18 months were given one booster dose of 5-dose sIPV in stage one, which was open-label. Unblinding was performed for stage two after completing primary immunization, which was randomized, blinded, and controlled; infants aged 18 months in the test group I-III, IPV group, and single-dose sIPV group were given one booster dose of 5-dose sIPV, conventional IPV, and single-dose sIPV, respectively, in stage two.
RESULTS: This study included 1438 infants in the immune persistence and safety set and 1387 infants in the booster per-protocol set. Fourteen months after primary immunization, the seropositivity rates (≥1:8) for types 1-3 were 100%, 99.88%, and 99.53% in the 5-dose sIPV groups; 100%, 98.97%, and 97.23% in the IPV group; and 99.66%, 100%, and 99.66% in the single-dose sIPV group. A total of 30 days after booster immunization, the seropositivity rates (≥1:8) of 3 serotypes in all the groups reached 100%. The geometric mean titers of neutralizing antibodies for types 1-3 in the 5-dose sIPV group were 9962.89, 10273, and 7870.21, with geometric mean increases of 15.76, 33.15, and 24.5, compared to the pre-booster level. The overall incidence of adverse reactions was 8.97%, with fever being the most common, observed at rates of 7.1%, 5.52%, and 7.96% in the 5-dose sIPV, IPV, and single-dose groups, respectively (p = 0.4845).
CONCLUSIONS: The 5-dose sIPV has shown promising immune persistence and robust immune response following a booster immunization, coupled with an acceptable safety profile.