Department of Paediatrics, Oxford Vaccine Group, University of Oxford, Oxford, United Kingdom.
Pediatr Infect Dis J. 2010 Nov;29(11):e71-9. doi: 10.1097/INF.0b013e3181f59f6d.
An investigational vaccine against serogroup B meningococcal (MenB) disease containing 3 main recombinant proteins (factor H-binding protein, Neisserial adhesion A, and Neisserial heparin-binding antigen) has been developed. We evaluated the immunogenicity and reactogenicity of a 3-dose course of this vaccine administered alone (recombinant MenB [rMenB]) or combined with the outer membrane vesicle (OMV) component of the vaccine used in New Zealand (rMenB+OMV).
A randomized, single-blind, comparative study of 60 healthy infants enrolled at 6 to 8 months of age and immunized with rMenB or rMenB+OMV at day 0, day 60, and at age 12 months. Blood samples obtained at baseline and 1 month following the second and third doses of vaccine were analyzed for serum bactericidal antibody (SBA) using human complement (hSBA) against 7 MenB strains. The putative correlate of protection was an hSBA titer of ≥4.
The per-protocol analysis included 24 of 30 participants randomized to each group. After 3 doses of rMenB+OMV, 90% or more of participants had an hSBA titer ≥4 for 5 MenB strains, with 70% of participants having an hSBA titer ≥4 for a sixth strain. rMenB alone was immunogenic for only 3 strains. Both vaccines were well tolerated.
Three doses of rMenB+OMV in the second half of infancy induce bactericidal antibodies against strains expressing vaccine antigens, demonstrating the potential for broader vaccine prevention of MenB disease. This vaccine is now in phase III clinical trials.
一种针对 B 群脑膜炎奈瑟菌（MenB）疾病的研究性疫苗，含有 3 种主要重组蛋白（因子 H 结合蛋白、奈瑟氏菌黏附 A 和奈瑟氏菌肝素结合抗原）已被开发出来。我们评估了单独接种（重组 MenB [rMenB]）或与新西兰使用的疫苗的外膜囊泡（OMV）成分联合接种（rMenB+OMV）3 剂方案的免疫原性和反应原性。
一项随机、单盲、对照研究，纳入了 60 名 6 至 8 个月大的健康婴儿，在第 0 天、第 60 天和 12 个月时接种 rMenB 或 rMenB+OMV。在第二次和第三次接种疫苗后 1 个月，采集基线和血液样本，使用人补体（hSBA）分析针对 7 株 MenB 菌株的血清杀菌抗体（SBA）。假设的保护相关物是 hSBA 滴度≥4。
符合方案分析包括每组 30 名随机参与者中的 24 名。接种 rMenB+OMV 3 剂后，90%或更多的参与者对 5 株 MenB 菌株的 hSBA 滴度≥4，70%的参与者对第 6 株菌株的 hSBA 滴度≥4。单独使用 rMenB 仅对 3 株菌株具有免疫原性。两种疫苗均具有良好的耐受性。
在婴儿下半年接种 3 剂 rMenB+OMV 可诱导针对表达疫苗抗原的菌株的杀菌抗体，表明该疫苗具有预防更广泛的 MenB 疾病的潜力。该疫苗目前正在进行 III 期临床试验。
