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肺炎球菌/流感嗜血杆菌蛋白 D 结合疫苗(PHiD-CV)与脑膜炎球菌 B 型(4CMenB)疫苗同时接种于婴儿的免疫原性:一项 3b 期、随机、对照试验的事后分析。

Immunogenicity of the pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) administered concomitantly with the meningococcal serogroup B (4CMenB) vaccine in infants: A post-hoc analysis in a phase 3b, randomised, controlled trial.

机构信息

Santa Casa de São Paulo School of Medical Sciences and CDEC, São Paulo, Brazil.

Hospital Clinico Universitario de Santiago de Compostela, Santiago de Compostela, Spain; Genetics, Vaccines and Pediatrics Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago, University of Santiago de Compostela, Spain.

出版信息

Vaccine. 2019 Aug 14;37(35):4858-4863. doi: 10.1016/j.vaccine.2019.07.021. Epub 2019 Jul 18.

Abstract

BACKGROUND

No data are currently available on immunogenicity of higher-valent pneumococcal conjugate vaccines when co-administered with a 4-component meningococcal serogroup B vaccine (4CMenB).

METHODS

Post-hoc analysis of pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) immunogenicity when co-administered with 4CMenB (2 + 1 schedule) and/or a CRM-conjugated meningococcal serogroup C vaccine (MenC-CRM) in a trial assessing 4CMenB reduced schedules and co-administration with MenC-CRM (NCT01339923). Infants were randomized to receive 4CMenB and MenC-CRM (Group 1) or MenC-CRM (Group 2) at 3, 5, and 12 months (M) of age. Both groups received PHiD-CV (3 + 1 schedule) as part of the Brazilian national immunisation programme at 3 M, 5 M, 7 M, and 12 M of age. Antibody responses were assessed pre-vaccination, 1 M post-dose 2, pre-booster, and 1 M post-booster.

RESULTS

Anti-pneumococcal antibody responses were in similar ranges in the two study groups.

CONCLUSIONS

4CMenB co-administration did not seem to impact antibody responses to PHiD-CV in infants.

摘要

背景

目前尚无关于更高价型肺炎球菌结合疫苗与 4 价脑膜炎球菌 B 型结合疫苗(4CMenB)同时使用的免疫原性数据。

方法

在一项评估 4CMenB 简化方案和与 MenC-CRM 联合使用的试验中,对肺炎球菌无型别流感嗜血杆菌蛋白 D 结合疫苗(PHiD-CV)与 4CMenB(2+1 方案)和/或 CRM 结合的脑膜炎球菌 C 型结合疫苗(MenC-CRM)同时使用的免疫原性进行了事后分析(NCT01339923)。婴儿随机接受 4CMenB 和 MenC-CRM(第 1 组)或仅接受 MenC-CRM(第 2 组),于 3、5 和 12 月龄(M)时接种。两组均在 3、5、7 和 12 M 龄时,根据巴西国家免疫规划,接受 PHiD-CV(3+1 方案)。在接种前、第 2 剂后 1 M、预加强和加强后 1 M 时评估抗体反应。

结果

两组研究中抗肺炎球菌抗体反应相似。

结论

4CMenB 联合使用似乎不会影响婴儿对 PHiD-CV 的抗体反应。

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