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首页> 外文期刊>Vaccine >A randomized study comparing the safety and immunogenicity of a conjugate vaccine combination containing meningococcal group C and pneumococcal capsular polysaccharide--CRM197 with a meningococcal group C conjugate vaccine in healthy infants: challen
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A randomized study comparing the safety and immunogenicity of a conjugate vaccine combination containing meningococcal group C and pneumococcal capsular polysaccharide--CRM197 with a meningococcal group C conjugate vaccine in healthy infants: challen

机译：一项随机对照研究，比较了包含C型脑膜炎球菌和肺炎球菌荚膜多糖-CRM197的结合疫苗组合与脑膜炎球菌C组结合疫苗在健康婴儿中的安全性和免疫原性：挑战

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BACKGROUND: A combination nonavalent pneumococcal-group C meningococcal conjugate vaccine (Pnc9-MenC) was previously found to be safe and immunogenic when administered to infants at 2, 3 and 4 months. This study describes the persistence of immunity at 12 months of age and the immunologic response to a challenge dose of either meningococcal polysaccharide vaccine (Meningivac A+C; MnA+C), or MenC. METHODS: A phase II, randomized, controlled trial of healthy infants. Subjects were given Pnc9-MenC or MenC vaccine at 2, 3 and 4 months of age and then challenged with either MenC or MnA+C. Group C meningococcal immunogenicity was measured by serum bactericidal assay (SBA) and an enzyme-linked immunosorbent assay (ELISA) adapted to measure antibody avidity pre- and post-challenge. RESULTS: The MenC vaccine was more immunogenic than the Pnc9-MenC vaccine in persistence of serogroup C meningococcal polysaccharide antibodies at 12 months of age. Post-challenge at 13 months there were significant differences between the four groups in the induction of serogroup C meningococcal polysaccharide antibodies. The responses to MenC/MenC were significantly higher than in the other groups (p<0.001) and the responses to Pnc9-MenC/MnA+C were significantly lower than in the other groups (p<0.001). There was no difference between the four groups in the proportions with geometric mean concentrations (GMC) greater than 2 microg/ml (p=0.18) or with SBA titres greater than or equal to the protective level of 1:8 (p=0.89). The SBA geometric mean ratio (GMR) between pre- and post-challenge was higher in the groups challenged with MenC than those challenged with MnA+C. Antibody avidity increased over time. CONCLUSION: We have shown that Pnc9-MenC primes effectively for immunological memory. At 13 months of age the highest immune responses were seen in the subjects primed and challenged with MenC alone. However, all groups achieved the threshold levels required for protection.
机译：背景：先前发现，在给婴儿2、3、4和4个月使用时，联合使用非价肺炎球菌C组脑膜炎球菌结合疫苗（Pnc9-MenC）是安全且具有免疫原性的。这项研究描述了12个月大时免疫力的持久性以及对激发剂量的脑膜炎球菌多糖疫苗（Meningivac A + C; MnA + C）或MenC的免疫应答。方法：II期健康婴儿的随机对照试验。在2、3和4个月大时给受试者接种Pnc9-MenC或MenC疫苗，然后用MenC或MnA + C攻击。 C组脑膜炎球菌的免疫原性是通过血清杀菌试验（SBA）和酶联免疫吸附测定（ELISA）进行的，以测定攻击前和攻击后的抗体亲和力。结果：在12个月大时，C血清群脑膜炎球菌多糖抗体的持久性较Menc疫苗更具免疫原性。攻击后13个月，四组血清C型脑膜炎球菌多糖抗体的诱导存在显着差异。对MenC / MenC的响应显着高于其他组（p <0.001），对Pnc9-MenC / MnA + C的响应显着低于其他组（p <0.001）。几何平均浓度（GMC）大于2 microg / ml（p = 0.18）或SBA滴度大于或等于保护水平1：8（p = 0.89）的比例在四组之间没有差异。 。在用MenC攻击的组中，攻击前后的SBA几何平均比率（GMR）高于用MnA + C攻击的组。抗体亲和力随时间增加。结论：我们已经证明Pnc9-MenC有效地引发了免疫记忆。在13个月大时，仅用MenC引发和攻击的受试者中观察到最高的免疫反应。但是，所有组都达到了保护所需的阈值水平。

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