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A Phase II, randomized, immunogenicity and safety study of a quadrivalent meningococcal conjugate vaccine, MenACYW-TT, in healthy adolescents in the United States
Vaccine ( IF 5.5 ) Pub Date : 2020-03-21 , DOI: 10.1016/j.vaccine.2020.03.017
Lee-Jah Chang 1 , James Hedrick 2 , Shane Christensen 3 , Judy Pan 1 , Emilia Jordanov 1 , Mandeep S Dhingra 1
Affiliation  

Background

MenACYW-TT is an investigational quadrivalent meningococcal conjugate vaccine intended for use in individuals ≥6 weeks of age. We evaluated the safety and immunogenicity of MenACYW-TT when compared to a licensed quadrivalent conjugate meningococcal vaccine (Menveo®; MCV4-CRM; GlaxoSmithKline, Italy), and when co-administered with tetanus, diphtheria, acellular pertussis (Tdap) and human papilloma virus (HPV4) vaccines in healthy meningococcal vaccine-naïve adolescents (10–17 years old) in the United States of America.

Methods

In this pivotal Phase II, open-label, multicenter study, 1715 participants were randomized to receive MenACYW-TT, MCV4-CRM, MenACYW-TT co-administered with Tdap and HPV4, or Tdap and HPV4 vaccines alone (NCT02199691).

The primary objective was to evaluate whether antibody responses to MenACYW-TT antigens were non-inferior to antibody responses after MCV4-CRM administration. Meningococcal antibody titers were determined using human complement serum bactericidal assay (hSBA) with titers measured at baseline, and 30 days post vaccination (D30). A vaccine seroresponse was defined as baseline titers <1:8 with post-vaccination titers ≥1:8 or baseline titers ≥1:8 with a ≥4-fold increase at post-vaccination. Safety data were collected up to six months post-vaccination.

Results

Non-inferiority was demonstrated for MenACYW-TT vs MCV4-CRM (primary endpoint), and for MenACYW-TT co-administered with Tdap and HPV4 vs MenACYW-TT alone (secondary endpoint). The vaccine seroresponse rate was higher with MenACYW-TT than with MCV4-CRM, for each serogroup: A: 75.6% vs 66.4%; C: 97.2% vs 72.6%; W: 86.2% vs 66.6%; Y: 97.0% vs 80.8%. The safety profiles of MenACYW-TT, MCV4-CRM, and Tdap and HPV4 vaccines, administered with or without MenACYW-TT, were comparable. There were no vaccine-related serious adverse events.

Conclusions

The MenACYW-TT vaccine was well tolerated and generated an immune response that was non-inferior to the licensed MCV4-CRM vaccine. Immunogenicity and safety profiles were comparable when MenACYW-TT was administered with or without Tdap and HPV4 vaccines in meningococcal vaccine-naïve adolescents.



中文翻译:

四价脑膜炎球菌结合疫苗 MenACYW-TT 在美国健康青少年中的 II 期随机免疫原性和安全性研究

背景

MenACYW-TT 是一种研究性四价脑膜炎球菌结合疫苗,旨在用于≥6 周龄的个体。我们评估了 MenACYW-TT 与获得许可的四价脑膜炎球菌结合疫苗(Menveo®;MCV4-CRM;GlaxoSmithKline,意大利)以及与破伤风、白喉、无细胞百日咳 (Tdap) 和人乳头状瘤共同给药时的安全性和免疫原性美利坚合众国未接种过脑膜炎球菌疫苗的健康青少年(10-17 岁)接种病毒 (HPV4) 疫苗。

方法

在这项关键的 II 期、开放标签、多中心研究中,1715 名参与者被随机分配接受 MenACYW-TT、MCV4-CRM、MenACYW-TT 与 Tdap 和 HPV4 联合接种,或单独接种 Tdap 和 HPV4 疫苗 (NCT02199691)。

主要目的是评估对 MenACYW-TT 抗原的抗体反应是否不劣于 MCV4-CRM 给药后的抗体反应。使用人补体血清杀菌试验 (hSBA) 测定脑膜炎球菌抗体滴度,在基线和接种后 30 天 (D30) 测量滴度。疫苗血清反应定义为基线滴度<1:8,接种后滴度≥1:8,或基线滴度≥1:8,接种后增加≥4倍。在接种疫苗后最多六个月收集安全数据。

结果

MenACYW-TT 与 MCV4-CRM(主要终点)以及 MenACYW-TT 与 Tdap 和 HPV4 与 MenACYW-TT 联合给药(次要终点)均证明了非劣效性。对于每个血清组,MenACYW-TT 的疫苗血清反应率高于 MCV4-CRM:A:75.6% vs 66.4%;C:97.2% 对 72.6%;W:86.2% 对 66.6%;Y:97.0% 对 80.8%。MenACYW-TT、MCV4-CRM、Tdap 和 HPV4 疫苗在联合或不联合 MenACYW-TT 的情况下的安全性具有可比性。没有发生与疫苗相关的严重不良事件。

结论

MenACYW-TT 疫苗耐受性良好,产生的免疫反应不劣于许可的 MCV4-CRM 疫苗。在未接种过脑膜炎球菌疫苗的青少年中,无论是否接种 Tdap 和 HPV4 疫苗,MenACYW-TT 的免疫原性和安全性均具有可比性。

更新日期:2020-03-22
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