Valente Pinto Marta, O'Connor Daniel, Galal Ushma, Clutterbuck Elizabeth A, Robinson Hannah, Plested Emma, Bibi Sagida, Camara Pellisso Susana, Hughes Harri, Kerridge Simon, Mujadidi Yama F, Findlow Helen, Borrow Ray, Snape Matthew D, Pollard Andrew J
Oxford Vaccine Group, Department of Paediatrics, Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.
Nuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, United Kingdom.
Open Forum Infect Dis. 2020 Apr 29;7(5):ofaa143. doi: 10.1093/ofid/ofaa143. eCollection 2020 May.
The 4-component capsular group B meningococcal vaccine (4CMenB) was licensed as a 4-dose infant schedule but introduced into the United Kingdom as 3 doses at 2, 4, and 12 months of age. We describe the immunogenicity and reactogenicity of the 2 + 1 schedule in infants.
Infants were randomized to receive 4CMenB with routine immunizations (test group) at 2, 4, and 12 months or 4CMenB alone at 6, 8, and 13 months of age (control group). Serum bactericidal antibody (SBA) assay against a serogroup B meningococcal reference strain (44/76-SL), memory B-cell responses to factor H binding protein, adhesion protein A, heparin binding antigen, Porin A (PorA), and reactogenicity was measured.
One hundred eighty-seven infants were randomized (test group: 94; control group: 93). In the test group, 4CMenB induced SBA titers above the putative protective threshold (1:4) after primary and booster doses in 97% of participants. Postbooster, the SBA GMT (72.1; 95% confidence interval [CI], 51.7-100.4) was numerically higher than the serum bactericidal antibody geometric mean titre (SBA GMT) determined post-primary vaccination (48.6; 95% CI, 37.2-63.4). After primary immunizations, memory B-cell responses did not change when compared with baseline controls, but frequencies significantly increased after booster. Higher frequency of local and systemic adverse reactions was associated with 4CMenB.
A reduced schedule of 4CMenB was immunogenic and established immunological memory after booster.
4组分B群脑膜炎球菌疫苗（4CMenB）获批用于婴儿4剂免疫程序，但在英国采用2、4和12月龄3剂免疫程序引入。我们描述了该2+1免疫程序在婴儿中的免疫原性和反应原性。
婴儿被随机分为两组，一组在2、4和12月龄时接受4CMenB联合常规免疫接种（试验组），另一组在6、8和13月龄时单独接种4CMenB（对照组）。检测针对B群脑膜炎球菌参考菌株（44/76-SL）的血清杀菌抗体（SBA）、对因子H结合蛋白、黏附蛋白A、肝素结合抗原、孔蛋白A（PorA）的记忆B细胞反应以及反应原性。
187名婴儿被随机分组（试验组94名；对照组93名）。在试验组中，97%的参与者在初次和加强剂量后，4CMenB诱导的SBA滴度高于假定的保护阈值（1:4）。加强免疫后，SBA几何平均滴度（GMT）（72.1；95%置信区间[CI]，51.7-100.4）在数值上高于初次接种疫苗后测定的血清杀菌抗体几何平均滴度（SBA GMT）（48.6；95%CI，37.2-63.4）。初次免疫后，与基线对照组相比，记忆B细胞反应没有变化，但加强免疫后频率显著增加。4CMenB与更高频率的局部和全身不良反应相关。
4CMenB减少剂量的免疫程序具有免疫原性，并在加强免疫后建立了免疫记忆。
