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


Sodiomon B SirimaAlphonse OuedraogoNouhoun BarryMohamadou SiribieAlfred TionoIssa NébiéAmadou KonatéGloria Damoaliga BergesAmidou DiarraMoussa OuedraogoEdith C BougoumaIssiaka SoulamaAlimatou HemaShrimati DattaYuanyuan LiangElizabeth T RotrosenJ Kathleen TracyLeslie P JamkaJennifer J OshinskyMarcela F PasettiKathleen M NeuzilMatthew B Laurens


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. We tested co-administration of Typbar TCV® (Bharat Biotech International) with measles-rubella (MR) and yellow fever (YF) vaccines.

Methods: We conducted a randomised, double-blind, and controlled, phase 2 trial in Ouagadougou, Burkina Faso. Healthy children aged 9-11 months were randomised 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 6 months after immunisation.

Results: We enrolled, randomised, 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; TYPHOID FEVER; Yellow fever vaccine; coadministration; typhoid conjugate vaccine.

Click here to read the article, published in The International Journal of Infectious Diseases.