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