免疫接种 6、8 和 12 个月后使用两种研究用 B 群脑膜炎球菌疫苗后 2 年的杀菌抗体持久性和学前加强剂量的免疫原性：一项随机临床试验的后续研究。

Bactericidal antibody persistence 2 years after immunization with 2 investigational serogroup B meningococcal vaccines at 6, 8 and 12 months and immunogenicity of preschool booster doses: a follow-on study to a randomized clinical trial.

机构信息

From the *Department of Paediatrics, University of Oxford and NIHR Oxford Biomedical Research Centre; †Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom; ‡Novartis Vaccines and Diagnostics Srl, Siena, Italy; and §Novartis Vaccines and Diagnostics Inc., Cambridge, MA.

出版信息

Pediatr Infect Dis J. 2013 Oct;32(10):1116-21. doi: 10.1097/INF.0b013e31829cfff2.

DOI:10.1097/INF.0b013e31829cfff2

PMID:23958808

Abstract

BACKGROUND

In a previous study, 60 infants receiving an investigational serogroup B meningococcal vaccine containing recombinant meningococcal proteins alone (rMenB) or combined with an outer membrane vesicle from Neisseria meningitidis (4CMenB) at 6, 8 and 12 months of age produced serum bactericidal antibodies (SBAs) against meningococcal strains expressing vaccine antigens. We studied persistence of this response and the response to a booster dose of vaccine.

METHODS

In this extension study, SBA titers were evaluated before and after a booster dose of rMenB or 4CMenB at 40 months of age. MenB vaccine naïve age-matched children served as a control group.

RESULTS

Before the booster doses, the proportions of 4CMenB recipients with SBA titers ≥1:4 were 36% (n = 14, 95% confidence interval: 13-65%) for strain 44/76-SL, 100% (77-100%) for 5/99, 14% (2-43%) for NZ98/254 and 79% (49-95%) for M10713. These percentages were 14% to 29% for rMenB recipients (n = 14), except for 5/99 (93%, 66-100%). For controls (n = 40), these proportions were ≤3% for all strains except M10713 (53%, 36-68%). One month after the boosters, ≥93% of 4CMenB recipients had SBA titers ≥1:4 for all 4 strains. For controls receiving their first dose of 4CMenB, 23% (11-39%) had SBA titers ≥1:4 for NZ98/254, compared with 62% to 87% for the remaining strains.

CONCLUSIONS

Bactericidal antibodies wane after infant immunization with rMenB or 4CMenB, but there is an anamnestic response to a booster dose. Booster doses of 4CMenB may be required to maintain immune protection through childhood and adolescence.

摘要

背景

在之前的一项研究中，60 名婴儿在 6、8 和 12 个月大时分别接种了含有重组脑膜炎奈瑟球菌蛋白的研究性 B 群脑膜炎球菌疫苗（rMenB）或结合了脑膜炎奈瑟球菌外膜囊泡的疫苗（4CMenB），这些婴儿产生了针对表达疫苗抗原的脑膜炎奈瑟球菌菌株的血清杀菌抗体（SBAs）。我们研究了这种反应的持久性以及对疫苗加强剂量的反应。

方法

在这项扩展研究中，在 40 个月大时，rMenB 或 4CMenB 加强剂量前和后评估了 SBAs 滴度。年龄匹配的 MenB 疫苗初免儿童作为对照组。

结果

在加强剂量前，4CMenB 组中 SBA 滴度≥1:4 的比例为 44/76-SL 菌株 36%（n=14，95%置信区间：13-65%）、5/99 菌株 100%（77-100%）、NZ98/254 菌株 14%（2-43%）和 M10713 菌株 79%（49-95%）。rMenB 组（n=14）的这些百分比为 14%至 29%，除了 5/99 菌株（93%，66-100%）。对于对照组（n=40），除了 M10713 菌株（53%，36-68%）外，所有菌株的这些比例均≤3%。加强剂量后 1 个月，所有 4 株菌株中≥93%的 4CMenB 组的 SBA 滴度≥1:4。对于首次接种 4CMenB 的对照组，NZ98/254 菌株的 SBA 滴度≥1:4 的比例为 23%（11-39%），而其余菌株的比例为 62%至 87%。