Laboratory of Bacterial Polysaccharides, Division of Bacterial, Parasitic, and Allergenic Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland.
Centers for Disease Control and Prevention, Atlanta, Georgia.
Clin Infect Dis. 2015 Nov 15;61 Suppl 5:S554-62. doi: 10.1093/cid/civ504.
PsA-TT (MenAfriVac) is a conjugated polysaccharide vaccine developed to eliminate group A meningococcal disease in Africa. Vaccination of African study participants with 1 dose of PsA-TT led to the production of anti-A polysaccharide antibodies and increased serum bactericidal activity measured using rabbit complement (rSBA). Bactericidal responses measured with human complement (hSBA) are presented here.
Sera collected before and at 28 days and 1 year after vaccination with either PsA-TT or quadrivalent polysaccharide vaccine (PsACWY) from a random, age-distributed 360-subject subset of the Meningitis Vaccine Project study of PsA-TT in Africans aged 2-29 years were tested for hSBA. Geometric mean titer, fold-rise, and threshold analyses were compared between vaccine groups and age groups. hSBA, rSBA, and immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) results were compared and assay correlation and agreement determined.
hSBA responses to PsA-TT were substantially higher than those to PsACWY at 28 days and 1 year following immunization, similar to previously reported rSBA and IgG results. The hSBA and IgG ELISA results identified differences between age groups that were not evident by rSBA. The rSBA data indicated sustained high titers 1 year after immunization, whereas hSBA GMTs at 1 year approached 4 in young children.
The high level of protection following PsA-TT immunization campaigns is consistent with the strong hSBA immune responses observed here. Future implementation decisions will likely depend on immunologic data and their long-term correlation with disease and carriage prevention. Expanded immunologic and epidemiologic surveillance may improve the interpretation of differences between these immunoassays.
PsA-TT(MenAfriVac)是一种结合多糖疫苗,旨在消除非洲 A 群脑膜炎球菌病。在非洲研究参与者中接种 1 剂 PsA-TT 会导致产生抗 A 多糖抗体,并增加使用兔补体(rSBA)测量的血清杀菌活性。本文介绍了用人补体(hSBA)测量的杀菌反应。
从非洲人 2-29 岁的 PsA-TT 脑膜炎疫苗项目研究中随机、年龄分布的 360 名受试者亚组中,收集接种 PsA-TT 或四价多糖疫苗(PsACWY)前后 28 天和 1 年的血清,检测 hSBA。比较疫苗组和年龄组之间的几何平均滴度、倍数增加和阈值分析。比较 hSBA、rSBA 和免疫球蛋白 G(IgG)酶联免疫吸附试验(ELISA)结果,并确定检测相关性和一致性。
接种后 28 天和 1 年,hSBA 对 PsA-TT 的反应明显高于对 PsACWY 的反应,与之前报道的 rSBA 和 IgG 结果相似。hSBA 和 IgG ELISA 结果确定了年龄组之间的差异,而 rSBA 数据则不明显。rSBA 数据表明接种后 1 年持续高滴度,而 hSBA GMT 在 1 年时接近年轻儿童的 4 岁。
PsA-TT 免疫接种运动后高水平的保护与这里观察到的强烈 hSBA 免疫反应一致。未来的实施决策可能取决于免疫数据及其与疾病和携带预防的长期相关性。扩大免疫和流行病学监测可能会改善这些免疫分析之间差异的解释。