a GSK , Siena , SI , Italy.
b PATH , San Francisco , CA , USA.
Hum Vaccin Immunother. 2019;15(3):725-731. doi: 10.1080/21645515.2018.1537756. Epub 2019 Jan 2.
The 4-component vaccine 4CMenB, developed against invasive disease caused by meningococcal serogroup B, is approved for use in infants in several countries worldwide. 4CMenB is mostly used as 3 + 1 schedule, except for the UK, where a 2 + 1 schedule is used, and where the vaccine showed an effectiveness of 82.9%. Here we compared the coverage of two 4CMenB vaccination schedules (3 + 1 [2.5, 3.5, 5, 11 months] versus 2 + 1 [3.5, 5, 11 months of age]) against 40 serogroup B strains, representative of epidemiologically-relevant isolates circulating in England and Wales in 2007-2008, using sera from a previous phase 3b clinical trial. The strains were tested using hSBA on pooled sera of infants, collected at one month post-primary and booster vaccination. 4CMenB coverage was defined as the percentage of strains with positive killing (hSBA titres ≥ 4 after immunisation and negative baseline hSBA titres < 2). Coverage of 4CMenB was 40.0% (95% confidence interval [CI]: 24.9-56.7) and 87.5% (95%CI: 73.2-95.8) at one month post-primary and booster vaccination, respectively, regardless of immunisation schedule. Using a more conservative threshold (post-immunisation hSBA titres ≥ 8; baseline ≤ 2), at one month post-booster dose, strain coverages were 80% (3 + 1) and 70% (2 + 1). We used a linear regression model to assess correlation between post-immunisation hSBA data for each strain in the two groups; Pearson's correlation coefficients were 0.93 and 0.99 at one month post-primary and booster vaccination. Overall, there is no evidence for a difference in strain coverage when 4CMenB is administered according to a 3 + 1 or 2 + 1 infant vaccination schedule.
针对由脑膜炎奈瑟菌 B 群引起的侵袭性疾病而开发的 4 组份疫苗 4CMenB 已在全球多个国家获得批准，可用于婴儿。4CMenB 主要以 3+1 方案使用，英国除外，英国使用 2+1 方案，该方案的疫苗有效性为 82.9%。在这里，我们比较了两种 4CMenB 免疫接种方案（3+1[2.5、3.5、5、11 个月]与 2+1[3.5、5、11 个月龄]）对 40 株 B 群血清型的覆盖率，这些血清型代表了 2007-2008 年在英格兰和威尔士流行的具有流行病学相关性的分离株，使用来自先前 3b 期临床试验的血清进行检测。在一次接种和加强接种后一个月，使用 hSBA 对婴儿混合血清中分离株进行检测。4CMenB 的覆盖率定义为具有阳性杀伤的菌株百分比（免疫后 hSBA 效价≥4，且阴性基线 hSBA 效价<2）。无论免疫接种方案如何，在一次接种和加强接种后一个月，4CMenB 的覆盖率分别为 40.0%（95%置信区间[CI]：24.9-56.7）和 87.5%（95%CI：73.2-95.8）。使用更保守的阈值（免疫后 hSBA 效价≥8；基线≤2），在加强接种后一个月，菌株覆盖率分别为 80%（3+1）和 70%（2+1）。我们使用线性回归模型评估两组中每个菌株免疫后 hSBA 数据之间的相关性；在一次接种和加强接种后一个月，Pearson 相关系数分别为 0.93 和 0.99。总体而言，按照 3+1 或 2+1 婴儿免疫接种方案使用 4CMenB 时，在菌株覆盖率方面没有证据表明存在差异。
