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在布基纳法索,15-23 月龄儿童同时接种 A 群脑膜炎球菌结合疫苗和麻疹-风疹联合疫苗与伤寒结合疫苗的安全性和免疫原性。

Safety and immunogenicity of co-administration of meningococcal type A and measles-rubella vaccines with typhoid conjugate vaccine in children aged 15-23 months in Burkina Faso.

机构信息

Groupe de Recherche Action en Santé, Ouagadougou, Burkina Faso, West Africa.

Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.

出版信息

Int J Infect Dis. 2021 Jan;102:517-523. doi: 10.1016/j.ijid.2020.10.103. Epub 2020 Nov 8.

Abstract

OBJECTIVES

The World Health Organization pre-qualified single-dose typhoid conjugate vaccine (TCV) and requested data on co-administration with routine vaccines. The co-administration of Typbar TCV (Bharat Biotech International) with routine group A meningococcal conjugate vaccine (MCV-A) and measles-rubella (MR) vaccine was tested.

METHODS

This was a double-blind, randomized controlled trial performed in Ouagadougou, Burkina Faso. Children were recruited at the 15-month vaccination visit and were assigned randomly (1:1:1) to three groups. Group 1 children received TCV plus control vaccine (inactivated polio vaccine) and MCV-A 28 days later; group 2 children received TCV and MCV-A; group 3 children received MCV-A and control vaccine. Routine MR vaccine was administered to all participants. Safety was assessed at 0, 3, and 7 days after immunization, and unsolicited adverse events and serious adverse events were assessed for 28 days and 6 months after immunization, respectively.

RESULTS

A total of 150 children were recruited and vaccinated. Solicited symptoms were infrequent and similar for TCV and control recipients, as were adverse events (group 1, 61.2%; group 2, 64.0%; group 3, 68.6%) and serious adverse events (group 1, 2.0%; group 2, 8.0%; group 3, 5.9%). TCV generated robust immunity without interference with MCV-A vaccine.

CONCLUSIONS

TCV can be safely co-administered at 15 months with MCV-A without interference. This novel study on the co-administration of TCV with MCV-A provides data to support large-scale uptake in sub-Saharan Africa.

摘要

目的

世界卫生组织将单价伤寒结合疫苗(TCV)预认证,并要求提供与常规疫苗联合使用的数据。测试了 Bharat Biotech International 生产的 Typbar TCV 与常规 A 群脑膜炎球菌结合疫苗(MCV-A)和麻疹-风疹(MR)疫苗联合使用的情况。

方法

这是在布基纳法索瓦加杜古进行的一项双盲、随机对照试验。在 15 个月的疫苗接种时招募儿童,并按 1:1:1 的比例随机分为三组。第 1 组儿童在 28 天后接受 TCV 和对照疫苗(灭活脊髓灰质炎疫苗)和 MCV-A;第 2 组儿童接受 TCV 和 MCV-A;第 3 组儿童接受 MCV-A 和对照疫苗。所有参与者均接种常规 MR 疫苗。在免疫后 0、3 和 7 天评估安全性,分别在免疫后 28 天和 6 个月评估不良事件和严重不良事件。

结果

共招募 150 名儿童并进行了疫苗接种。TCV 和对照疫苗的接种者出现的征状均较罕见且相似,不良事件(第 1 组,61.2%;第 2 组,64.0%;第 3 组,68.6%)和严重不良事件(第 1 组,2.0%;第 2 组,8.0%;第 3 组,5.9%)也相似。TCV 产生了强大的免疫反应,而不会干扰 MCV-A 疫苗。

结论

TCV 可在 15 个月时与 MCV-A 安全联合使用,且不会产生干扰。这项关于 TCV 与 MCV-A 联合使用的新研究提供了数据支持,以在撒哈拉以南非洲地区广泛采用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/be3c/7762715/672f1ce05aa2/gr1.jpg

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