Baxter Roger, Reisinger Keith, Block Stanley L, Percell Sandra, Odrljin Tatjana, Dull Peter M, Smolenov Igor
From the *Kaiser Permanente Vaccine Study Center, Oakland, CA; †Primary Physicians Research, Pittsburgh, PA; ‡Kentucky Pediatric and Adult Research, Bardstown, KY; and §Novartis Vaccines, Cambridge, MA.
Pediatr Infect Dis J. 2014 Nov;33(11):1169-76. doi: 10.1097/INF.0000000000000438.
The aim of this study was to evaluate antibody persistence 5 years after primary vaccination with the quadrivalent meningococcal conjugate vaccines MenACWY-CRM or MenACWY-D and 2 years after a booster dose of MenACWY-CRM, in the context of a phase 3 study.
Subjects (aged 19.2 ± 2.3 years) were assigned to 5 groups according to whether they had previously received primary vaccination (at 14.2 ± 2.2 years) with MenACWY-CRM (N = 131) or MenACWY-D (N = 76), a booster dose of MenACWY-CRM 3 years after primary vaccination with MenACWY-CRM (N = 44) or MenACWY-D (N = 31) or no vaccination (N = 107). The immunogenicity measures were percentages of subjects with serum bactericidal activity (hSBA) ≥ 1:8 for serogroups A, C, W and Y and hSBA geometric mean titers. Comparisons with age-matched, vaccine-naive subjects were performed.
A majority of subjects vaccinated 5 years previously maintained hSBA ≥ 1:8 against serogroups C, W and Y in the MenACWY-CRM (59%-82%) and MenACWY-D groups (54%-73%); this was lower for serogroup A in both groups. There was a decline in antibody titers after primary vaccination, especially in the first 2 years postprimary vaccination, with steady concentrations during the next 3 years. Two years after MenACWY-CRM booster vaccination the percentages of subjects with hSBA ≥ 1:8 ranged from 77% to 100% across serogroups and geometric mean titers were 2.5- to 8-fold higher than prebooster values across serogroups.
Booster vaccination with MenACWY-CRM elicited a robust immune response during the 2-year follow-up period, irrespective of previous vaccination.
在一项3期研究中,本研究的目的是评估在接种四价脑膜炎球菌结合疫苗MenACWY-CRM或MenACWY-D进行初次疫苗接种5年后以及接种MenACWY-CRM加强剂量2年后的抗体持久性。
根据受试者在14.2±2.2岁时是否曾接种过MenACWY-CRM(N = 131)或MenACWY-D(N = 76)、在接种MenACWY-CRM或MenACWY-D进行初次疫苗接种3年后是否接种过MenACWY-CRM加强剂量(N = 44或N = 31)或是否未接种疫苗(N = 107),将受试者(年龄19.2±2.3岁)分为5组。免疫原性指标为血清杀菌活性(hSBA)≥1:8的A、C、W和Y血清群受试者的百分比以及hSBA几何平均滴度。与年龄匹配的未接种疫苗受试者进行了比较。
大多数5年前接种疫苗的受试者在MenACWY-CRM组(59%-82%)和MenACWY-D组(54%-73%)中针对C、W和Y血清群维持hSBA≥1:8;两组中A血清群的这一比例较低。初次疫苗接种后抗体滴度下降,尤其是在初次接种后的前2年,在接下来的3年中浓度稳定。MenACWY-CRM加强疫苗接种2年后,各血清群hSBA≥1:8的受试者百分比范围为77%至100%,各血清群的几何平均滴度比加强前值高2.5至8倍。
无论之前是否接种过疫苗,接种MenACWY-CRM加强疫苗在2年随访期内均引发了强烈的免疫反应。