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Randomized Controlled Trial
. 2021 Jan:102:517-523.
doi: 10.1016/j.ijid.2020.10.103. Epub 2020 Nov 8.

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  1 , Alphonse Ouedraogo  1 , Nouhoun Barry  1 , Mohamadou Siribie  1 , Alfred B Tiono  1 , Issa Nébié  1 , Amadou T Konaté  1 , Gloria Damoaliga Berges  1 , Amidou Diarra  1 , Moussa Ouedraogo  1 , Issiaka Soulama  1 , Alimatou Hema  1 , Shrimati Datta  2 , Yuanyuan Liang  2 , Elizabeth T Rotrosen  2 , J Kathleen Tracy  2 , Leslie P Jamka  2 , Kathleen M Neuzil  2 , Matthew B Laurens  3
Affiliations
Randomized Controlled Trial

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 et al. Int J Infect Dis. 2021 Jan.

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.

Keywords: Burkina Faso; Co-administration; Measles–rubella vaccine; Meningococcal vaccines; Sub-Saharan Africa; Typhoid conjugate vaccine.

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Figures

Figure 1
Figure 1
Disposition of participants (CONSORT flow diagram).
Figure 2
Figure 2
(A) Anti-Vi IgG antibody titres before vaccination (day 0) and 28 days after vaccination. (B) Serum bactericidal antibody titres before vaccination (day 0) and 28 days after vaccination. (C) Anti-tetanus IgG titres before vaccination and 28 days after vaccination. *Using the two-sample t-test with unequal variances on log10 transformed data. **Using the paired t-test on log10 transformed data.
See this image and copyright information in PMC

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