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CYD-TDV登革热疫苗:疗效、免疫原性和安全性的系统评价与荟萃分析

CYD-TDV dengue vaccine: systematic review and meta-analysis of efficacy, immunogenicity and safety.

作者信息

Godói Isabella Piassi, Lemos Livia Lovato Pires, de Araújo Vânia Eloisa, Bonoto Braúlio Cesar, Godman Brian, Guerra Júnior Augusto Afonso

机构信息

Programa de Pós-graduação em Medicamentos e Assistência Farmacêutica, sala 1023, Faculdade de Farmácia, Universidade Federal de Minas Gerais, Av. Presidente Antônio Carlos, 6627, Campus Pampulha, Belo Horizonte, Minas Gerais, CEP 31270-901, Brazil.

SUS Collaborating Centre for Technology Assessment & Excellence in Health, sala 1042, Faculdade de Farmácia, Universidade Federal de Minas Gerais, Av. Presidente Antônio Carlos, 6627, Campus Pampulha, Belo Horizonte, Minas Gerais, CEP 31270-901, Brazil.

出版信息

J Comp Eff Res. 2017 Mar;6(2):165-180. doi: 10.2217/cer-2016-0045. Epub 2017 Jan 13.

Abstract

INTRODUCTION

Dengue virus (DENV) is a serious global health problem. CYD-TDC (Dengvaxia) was the first vaccine to gain regulatory approval to try and address this problem.

AIM

Summarize all available evidence on the immunogenicity, efficacy and safety of the CYD-TDV dengue vaccine.

METHOD

Meta-analysis and systematic review.

RESULTS

The best and worst immunogenicity results were for DENV4 and DENV1, respectively. Vaccine efficacy of 60% was derived from studies with participants aged 2-16 years old, with DENV4 and DENV2 presenting the best and worst results, respectively. Erythema and swelling were more frequent with CYD-TDV. No differences were detected for systemic adverse events.

CONCLUSION

CYD-TDV showed moderate efficacy in children and adolescents. From the immunogenicity results in adults, we can expect satisfactory efficacy from vaccination in this population.

摘要

引言

登革病毒(DENV)是一个严重的全球健康问题。CYD-TDC(登革热疫苗)是首个获得监管批准以试图解决这一问题的疫苗。

目的

总结关于CYD-TDV登革热疫苗免疫原性、有效性和安全性的所有现有证据。

方法

荟萃分析和系统评价。

结果

免疫原性最佳和最差的结果分别针对DENV4和DENV1。60%的疫苗效力来自对2至16岁参与者的研究,其中DENV4和DENV2分别呈现最佳和最差结果。CYD-TDV导致的红斑和肿胀更为常见。全身不良事件未发现差异。

结论

CYD-TDV在儿童和青少年中显示出中等效力。从成人的免疫原性结果来看,我们可以预期该疫苗在这一人群中接种会产生令人满意的效力。

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