General Practice for Children and Adolescents, Jindrichuv Hradec, Czech Republic.
Faculty of Medicine, University of Rzeszów, Rzeszów, Poland and Individual Specialist Medical Practice, Krakow, Poland.
Vaccine. 2022 Jan 21;40(2):351-358. doi: 10.1016/j.vaccine.2021.11.053. Epub 2021 Dec 24.
The MenB-FHbp vaccine is licensed to prevent meningococcal serogroup B disease on either a 2-dose (0, 6 months) or 3-dose (0, 1-2, 6 months) series. This phase 3 study further assessed the immunogenicity and safety of the 2-dose MenB-FHbp schedule.
Subjects 10-25 years of age received MenB-FHbp (months 0, 6) and the quadrivalent meningococcal conjugate vaccine MenACWY-CRM (month 0). Primary immunogenicity endpoints included percentages of subjects achieving ≥ 4-fold increases from baseline in serum bactericidal antibody using human complement (hSBA) titers for 4 diverse, vaccine-heterologous primary serogroup B test strains and titers ≥ lower limit of quantitation (LLOQ; 1:8 or 1:16) for all 4 primary strains combined (composite response) after dose 2; a titer ≥ 1:4 is the accepted correlate of protection. Percentages of participants with hSBA titers ≥ LLOQ for 10 additional vaccine-heterologous strains were also assessed; positive predictive values of primary strain responses for secondary strain responses were determined. Safety was assessed.
Overall, 1057 subjects received dose 1 and 946 received dose 2 of MenB-FHbp. Percentages of participants achieving ≥ 4-fold increases in hSBA titers against each primary strain after dose 2 ranged from 67.4% to 95.0% and the composite response was 74.3%. Primary strain responses were highly predictive of secondary strain responses. Most reactogenicity events were mild-to-moderate in severity and did not lead to withdrawal from the study. Adverse events (AEs) considered by the investigator to be related to vaccination occurred in 4.2% (44/1057) of subjects, and there were no serious AEs or newly diagnosed chronic medical conditions considered related to vaccination.
MenB-FHbp administered at 0, 6 months was well tolerated and induced protective bactericidal antibody responses against diverse serogroup B strains. Findings provide further support for the continued use of MenB-FHbp on a 2-dose schedule in this population.
MenB-FHbp 疫苗经许可用于预防脑膜炎奈瑟菌 B 群疾病，可采用 2 剂（0、6 个月）或 3 剂（0、1-2、6 个月）系列接种。本 3 期研究进一步评估了 2 剂 MenB-FHbp 方案的免疫原性和安全性。
年龄为 10-25 岁的受试者接受 MenB-FHbp（第 0、6 个月）和 4 价脑膜炎球菌结合疫苗 MenACWY-CRM（第 0 个月）。主要免疫原性终点包括血清杀菌抗体（hSBA）滴度相对于基线的 4 种不同、疫苗异源的原发性 B 群测试菌株的 4 倍增加百分比，以及所有 4 种主要菌株联合的定量下限（LLOQ；1:8 或 1:16）的滴度（复合反应）在第 2 剂后；1:4 的滴度是公认的保护相关性。还评估了对 10 种额外疫苗异源菌株的 hSBA 滴度≥LLOQ 的参与者百分比；确定了主要菌株反应对次要菌株反应的阳性预测值。评估了安全性。
总体而言，1057 名受试者接受了第 1 剂 MenB-FHbp，946 名受试者接受了第 2 剂。第 2 剂后，每种主要菌株的 hSBA 滴度增加 4 倍的参与者百分比范围为 67.4%至 95.0%，复合反应为 74.3%。主要菌株反应对次要菌株反应具有高度预测性。大多数不良反应事件的严重程度为轻度至中度，且并未导致退出研究。研究者认为与接种相关的不良事件（AE）发生在 4.2%（44/1057）的受试者中，没有严重的 AE 或新诊断的与接种相关的慢性医疗状况。
0、6 个月时给予 MenB-FHbp 具有良好的耐受性，并诱导针对多种 B 群菌株的保护性杀菌抗体反应。这些发现为在该人群中继续使用 2 剂 MenB-FHbp 方案提供了进一步支持。
