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首页> 美国卫生研究院文献>Clinical and Diagnostic Laboratory Immunology >Immunogenicity and Safety of a Meningococcal Quadrivalent Conjugate Vaccine in Saudi Arabian Adolescents Previously Vaccinated with One Dose of Bivalent and Quadrivalent Meningococcal Polysaccharide Vaccines: a Phase III Controlled Randomized and Modified Blind-Observer Study
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Immunogenicity and Safety of a Meningococcal Quadrivalent Conjugate Vaccine in Saudi Arabian Adolescents Previously Vaccinated with One Dose of Bivalent and Quadrivalent Meningococcal Polysaccharide Vaccines: a Phase III Controlled Randomized and Modified Blind-Observer Study

机译：脑膜炎球菌四价共轭疫苗在先前接种了一剂二价和四价脑膜炎球菌多糖疫苗的免疫原性和安全性：一项III期对照随机和改良盲人研究。

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Reduced immune responses to repeated polysaccharide vaccination have been previously reported, but there are limited immunogenicity data on the use of meningococcal polysaccharide vaccine (PSV) followed by meningococcal conjugate vaccine. Saudi Arabian adolescents (aged 16 to 19 years) who had previously been vaccinated with ≥1 dose of bivalent meningococcal polysaccharide vaccine and 1 dose of quadrivalent meningococcal polysaccharide (MPSV4) were enrolled in a controlled, randomized, and modified observer-blind study (collectively termed the PSV-exposed group). The PSV-exposed group was randomized to receive either quadrivalent meningococcal conjugate vaccine (MCV4) (n = 145 PSV-exposed/MCV4 group) or MPSV4 (n = 142 PSV-exposed/MPSV4 group), and a PSV-naïve group received MCV4 (n = 163). Serum samples collected prevaccination and 28 days postvaccination were measured by baby rabbit serum bactericidal antibody (rSBA) assay, and vaccine tolerability and safety were also evaluated. For each serogroup, the postvaccination geometric mean titers (GMTs) were significantly higher in the PSV-naïve group than in either group comprised of the PSV-exposed participants. The postvaccination serogroup C rSBA GMT was significantly higher in the PSV-MCV4 group than in the PSV-MPSV4 group after adjusting for prevaccination GMTs. Although not statistically significant, similar differences were observed for serogroups A, Y, and W-135. No worrisome safety signals were detected. This study demonstrated MCV4 to be safe and immunogenic in those who had previously received polysaccharide vaccination, and it suggests that conjugate vaccine can partially compensate for the hyporesponsiveness seen with repeated doses of polysaccharide vaccine.
机译：先前已经报道了对重复多糖疫苗接种的免疫应答降低，但是关于使用脑膜炎球菌多糖疫苗（PSV）随后使用脑膜炎球菌结合疫苗的免疫原性数据有限。先前曾接受≥1剂量的二价脑膜炎球菌多糖疫苗和1剂量的四价脑膜炎球菌多糖（MPSV4）接种的沙特阿拉伯青少年（16至19岁）参加了一项对照，随机和改良的观察者盲研究（集体称为暴露于PSV的小组）。暴露于PSV的组被随机分配接受四价脑膜炎球菌结合疫苗（MCV4）（n = 145暴露于PSV / MCV4组）或MPSV4（n = 142暴露于PSV / MPSV4组），未接受PSV的组接受MCV4 （n = 163）。疫苗接种前和疫苗接种后28天收集的血清样品通过小兔子血清杀菌抗体（rSBA）测定进行测量，并评估了疫苗的耐受性和安全性。对于每个血清组，未接种PSV的组的疫苗接种后几何平均滴度（GMT）均显着高于接受PSV的参与者组成的两组。调整疫苗接种前GMT后，PSV-MCV4组的疫苗接种后血清C rSBA GMT显着高于PSV-MPSV4组。尽管没有统计学显着性，但观察到血清群A，Y和W-135的相似差异。没有检测到令人担忧的安全信号。这项研究表明，MCV4在以前接受过多糖疫苗接种的人中是安全的和免疫原性的，这表明结合疫苗可以部分补偿重复剂量多糖疫苗中出现的低反应性。

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