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

Sodiomon B Sirima,Alphonse Ouedraogo,Nouhoun Barry,Mohamadou Siribie,Alfred B Tiono,Issa Nébié,Amadou T Konaté,Gloria Damoaliga Berges,Amidou Diarra,Moussa Ouedraogo,Issiaka Soulama,Alimatou Hema,Shrimati Datta,Yuanyuan Liang,Elizabeth T Rotrosen,J Kathleen Tracy,Leslie P Jamka,Kathleen M Neuzil,Matthew B Laurens

doi:10.1016/j.ijid.2020.10.103

Abstract

ObjectivesThe 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. MethodsThis 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. ResultsA 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. ConclusionsTCV 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.

Highlights

Typhoid fever is an acute infection caused by exposure to Salmonella enterica serovar Typhi (Salmonella Typhi) in food or water contaminated with human faeces
These results provide evidence for public health officials and policymakers who are considering the implementation of routine typhoid conjugate vaccine (TCV) administration in endemic areas, where MCV-A is routinely given
While this study was small, the safety and reactogenicity profiles are reassuring and consistent with those reported in studies performed in other parts of the world, including India and Pakistan, where over 200,000 doses were administered to children 6 months to 15 years of age during vaccination campaigns in 2018 (World Health Organization, 2019a)

Summary

Introduction

Typhoid fever is an acute infection caused by exposure to Salmonella enterica serovar Typhi (Salmonella Typhi) in food or water contaminated with human faeces. Typhoid fever incidence is highest in school-age children, but it is increasingly documented in children under five (Kim et al, 2019). Estimating typhoid fever incidence is challenging in low- and middle-income countries due to the non-specific clinical presentation and limited access to blood culture, the most reliable diagnostic test.

Objectives

Results

Conclusion