一种五价A、C、W、Y群脑膜炎球菌疫苗在既往接种过A、C、W、Y群脑膜炎球菌疫苗的青少年和年轻成人中的免疫原性、反应原性及安全性：一项3期随机对照临床研究
Immunogenicity, Reactogenicity, and Safety of a Pentavalent Meningococcal ABCWY Vaccine in Adolescents and Young Adults Who Had Previously Received a Meningococcal ACWY Vaccine: A Phase 3, Randomized Controlled Clinical Study.
作者信息
Nolan Terry, Bhusal Chiranjiwi, Hoberman Alejandro, Llapur Conrado J, Voloshyna Olga, Fink Ezekiel, Gentile Angela, Wallace Garry, Richmond Peter C, Domachowske Joseph B, Mzolo Thembile, Lattanzi Maria, Toneatto Daniela
机构信息
Peter Doherty Institute at the University of Melbourne, VIC, Australia.
Murdoch Children's Research Institute, Melbourne, VIC, Australia.
出版信息
Clin Infect Dis. 2025 Apr 30;80(4):752-760. doi: 10.1093/cid/ciae622.
BACKGROUND
A MenABCWY vaccine containing 4CMenB and MenACWY-CRM vaccine components has been developed to protect against the 5 meningococcal serogroups that cause most invasive disease cases.
METHODS
In this phase 3 study, healthy participants aged 15-25 years, who had received MenACWY vaccination ≥4 years previously, were randomized (1:1) to receive 2 MenABCWY doses 6 months apart or 1 MenACWY-CRM dose. Primary objectives were to demonstrate the noninferiority of MenABCWY 1 month postvaccination versus MenACWY-CRM, with a lower limit of 2-sided 95% confidence interval above -10% for group differences in 4-fold rise in human serum bactericidal antibody (hSBA) titers against serogroups ACWY, and to evaluate reactogenicity and safety. Secondary endpoints included percentages of participants with hSBA titers greater than or equal to the lower limit of quantitation (≥LLOQ) against serogroups ACWY and vaccine antigen-specific serogroup B (MenB) indicator strains.
RESULTS
Noninferiority of MenABCWY versus MenACWY-CRM was demonstrated following each MenABCWY dose. Percentages of participants with hSBA titers ≥LLOQ for serogroups ACWY were 97.9%-98.9% and 99.5%-100% following 1 and 2 MenABCWY doses, respectively, and 96.8%-99.0% following 1 MenACWY-CRM dose. After 2 MenABCWY doses, 75.6%-96.3% of participants had hSBA titers ≥LLOQ against MenB indicator strains. The MenABCWY vaccine was well tolerated in MenACWY-primed individuals, with a favorable safety profile.
CONCLUSIONS
Immune responses against serogroups ACWY following 1 and 2 doses of investigational MenABCWY vaccine are noninferior to those following MenACWY-CRM in MenACWY-primed adolescents and young adults. Robust immune responses were observed against MenB indicator strains after 2 MenABCWY doses administered 6 months apart. Clinical Trials Registration. NCT04707391.
背景
已研发出一种包含4CMenB和MenACWY-CRM疫苗成分的MenABCWY疫苗，用于预防导致大多数侵袭性疾病病例的5种脑膜炎球菌血清群。
方法
在这项3期研究中，将≥4年前接种过MenACWY疫苗的15至25岁健康参与者随机分为两组（1:1），分别接受间隔6个月的2剂MenABCWY疫苗或1剂MenACWY-CRM疫苗。主要目标是证明接种疫苗1个月后MenABCWY相对于MenACWY-CRM的非劣效性，血清群ACWY的人血清杀菌抗体（hSBA）滴度4倍升高的组间差异的双侧95%置信区间下限高于-10%，并评估反应原性和安全性。次要终点包括hSBA滴度大于或等于针对血清群ACWY和疫苗抗原特异性血清群B（MenB）指示菌株的定量下限（≥LLOQ）的参与者百分比。
结果
每次接种MenABCWY疫苗后均证明MenABCWY相对于MenACWY-CRM具有非劣效性。接种1剂和2剂MenABCWY疫苗后，血清群ACWY的hSBA滴度≥LLOQ的参与者百分比分别为97.9%-98.9%和99.5%-100%，接种1剂MenACWY-CRM疫苗后为96.8%-99.0%。接种2剂MenABCWY疫苗后，75.6%-96.3%的参与者针对MenB指示菌株的hSBA滴度≥LLOQ。MenABCWY疫苗在接受过MenACWY疫苗初免的个体中耐受性良好，安全性良好。
结论
在接受过MenACWY疫苗初免的青少年和年轻人中，接种1剂和2剂研究性MenABCWY疫苗后对血清群ACWY的免疫反应不劣于接种MenACWY-CRM后的免疫反应。在间隔6个月接种2剂MenABCWY疫苗后，观察到针对MenB指示菌株的强大免疫反应。临床试验注册编号：NCT04707391。
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