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

• Main Authors: Sodiomon B. Sirima, Alphonse Ouedraogo, Nouhoun Barry, Mohamadou Siribie, Alfred Tiono, Issa Nébié, Amadou Konaté, Gloria Damoaliga Berges, Amidou Diarra, Moussa Ouedraogo, Edith C. Bougouma, Issiaka Soulama, Alimatou Hema, Shrimati Datta, Yuanyuan Liang, Elizabeth T. Rotrosen, J. Kathleen Tracy, Leslie P. Jamka, Jennifer J. Oshinsky, Marcela F. Pasetti, Kathleen M. Neuzil, Matthew B. Laurens
• Format: Article
• Language: English
• Published: Elsevier 2021-07-01
• Series: International Journal of Infectious Diseases
• Subjects: Typhoid conjugate vaccine; Typhoid fever; Burkina Faso; Yellow fever vaccine; Coadministration
• Online Access: http://www.sciencedirect.com/science/article/pii/S1201971221004616

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.