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Clinical Trial
. 2021 Jul:108:465-472.
doi: 10.1016/j.ijid.2021.05.061. Epub 2021 Jun 1.

Safety and immunogenicity of Vi-typhoid conjugate vaccine co-administration with routine 9-month vaccination in Burkina Faso: A randomized controlled phase 2 trial

Sodiomon B Sirima  1 , Alphonse Ouedraogo  1 , Nouhoun Barry  1 , Mohamadou Siribie  1 , Alfred Tiono  1 , Issa Nébié  1 , Amadou Konaté  1 , Gloria Damoaliga Berges  1 , Amidou Diarra  1 , Moussa Ouedraogo  1 , Edith C Bougouma  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 , Jennifer J Oshinsky  2 , Marcela F Pasetti  2 , Kathleen M Neuzil  2 , Matthew B Laurens  3
Affiliations
Clinical Trial

Safety and immunogenicity of Vi-typhoid conjugate vaccine co-administration with routine 9-month vaccination in Burkina Faso: A randomized controlled phase 2 trial

Sodiomon B Sirima et al. Int J Infect Dis. 2021 Jul.

Abstract

Objectives: In 2017, the World Health Organisation (WHO) pre-qualified a single-dose typhoid conjugate vaccine (TCV) and identified TCV co-administration studies as a research priority. Accordingly, we tested co-administration of Typbar TCV® (Bharat Biotech International) with measles-rubella (MR) and yellow fever (YF) vaccines.

Methods: We conducted a randomized, double-blind, and controlled, phase 2 trial in Ouagadougou, Burkina Faso. Healthy children aged 9-11 months were randomized 1:1 to receive TCV (Group 1) or control vaccine (inactivated polio vaccine (IPV), Group 2). Vaccines were administered intramuscularly with routine MR and YF vaccines. Safety was assessed by (1) local and systemic reactions on days 0, 3, and 7; (2) unsolicited adverse events within 28 days; and (3) serious adverse events (SAEs) within six months after immunization.

Results: We enrolled, randomized, and vaccinated 100 eligible children (49 Group 1 and 51 Group 2). Safety outcomes occurred with similar frequency in both groups: local/solicited reactions (Group 1: 1/49, Group 2: 3/50), systemic/solicited reactions (Group 1: 4/49, Group 2: 9/50), unsolicited adverse events (Group 1: 26/49, Group 2: 33/51), and SAEs (Group 1: 2/49, Group 2: 3/51). TCV conferred robust immunogenicity without interference with MR or YF vaccines.

Conclusion: TCV can be safely co-administered with MR and YF vaccines to children at the 9-month vaccination visit.

Keywords: Burkina Faso; Coadministration; Typhoid conjugate vaccine; Typhoid fever; Yellow fever vaccine.

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Conflict of interest statement

Declaration of Competing Interest The authors report no declarations of interest.

Figures

Figure 1
Figure 1
Disposition of participants (CONSORT flow diagram).
Figure 2
Figure 2
(A) Anti-Vi IgG antibody titers before vaccination (day 0) and 28 days after vaccination. (B) Anti-yellow fever neutralizing antibody titers before vaccination (day 0) and 28 days after vaccination. (C) Anti-measles titers before vaccination (day 0) and 28 days after vaccination. (D) Anti-rubella antibody titers before vaccination (day 0) and 28 days after vaccination. (E) Anti-tetanus IgG antibody titers before vaccination (day 0) and 28 days after vaccination.
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