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健康成年人中两种四价脑膜炎球菌结合疫苗(CRM197 和白喉类毒素)免疫应答的比较。

Comparison of Immune Responses to Two Quadrivalent Meningococcal Conjugate Vaccines (CRM197 and Diphtheria Toxoid) in Healthy Adults.

机构信息

Department of Pediatrics, Ewha Womans University College of Medicine, Seoul, Korea.

Center for Vaccine Evaluation and Study, Ewha Womans University College of Medicine, Seoul, Korea.

出版信息

J Korean Med Sci. 2019 Jun 17;34(23):e169. doi: 10.3346/jkms.2019.34.e169.

Abstract

BACKGROUND

After the introduction of the meningococcal ACWY-CRM197 conjugate vaccine (MenACWY-CRM) in 2012 and the meningococcal ACWY-diphtheria toxoid conjugate vaccine (MenACWY-DT) in 2014, immunization was recommended for certain high-risk groups including new military recruits in Korea. However, comparative immunogenicity studies for these vaccines have not been performed in Korea. Here, we compared the immunogenicity of these two vaccines in healthy adults.

METHODS

A total of 64 adults, 20-49 years of age, were randomly divided into two groups (1:1) to receive either of the two vaccines. The sera were obtained before and 1 month after vaccination and tested for serogroup-specific serum bactericidal activity using baby rabbit complement.

RESULTS

There were no significant differences post-vaccination in the geometric mean indices and the seropositive rate to all serogroups between the vaccines. The proportion of seropositive subjects after vaccination ranged from 88% to 100%.

CONCLUSION

Both meningococcal conjugate vaccines showed good immunogenicity in healthy Korean adults without statistically significant differences. Further investigations for serotype distribution of circulating meningococci and the immune interference between other diphtheria toxin-containing vaccines concomitantly used for military recruits are needed to optimize immunization policies.

TRIAL REGISTRATION

Clinical Research Information Service Identifier: KCT0002460.

摘要

背景

2012 年引入脑膜炎奈瑟菌 ACWY-CRM197 结合疫苗(MenACWY-CRM)和 2014 年引入脑膜炎奈瑟菌 ACWY-白喉类毒素结合疫苗(MenACWY-DT)后,韩国建议对某些高危人群(包括新兵)进行免疫接种。然而,尚未在韩国进行这些疫苗的免疫原性比较研究。在此,我们比较了这两种疫苗在健康成年人中的免疫原性。

方法

共有 64 名 20-49 岁的成年人被随机分为两组(1:1),分别接种这两种疫苗。接种前和接种后 1 个月采集血清,使用兔补体检测血清杀菌活性。

结果

接种后,两种疫苗之间所有血清型的几何平均指数和血清阳性率均无显著差异。接种后血清阳性率在 88%至 100%之间。

结论

两种脑膜炎球菌结合疫苗在韩国健康成年人中均表现出良好的免疫原性,无统计学差异。为了优化免疫接种政策,需要进一步调查循环脑膜炎奈瑟菌的血清型分布以及同时用于新兵的其他含白喉类毒素疫苗的免疫干扰。

试验注册

临床研究信息服务标识符:KCT0002460。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d6e1/6565927/d13816c30dac/jkms-34-e169-g001.jpg

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