Immunogenicity and Tolerability of Booster Typhoid Conjugate Vaccine (TCV) 5-6 Years After Initial Dose in Children in Burkina Faso

Overview

This study evaluated the persistence of immunity following primary typhoid conjugate vaccination in early childhood and assessed the immunogenicity and safety of a booster dose administered 5-6 years later. Children previously enrolled in a Phase 2 randomized clinical trial of Vi-tetanus toxoid conjugate vaccine (Vi-TT) were re-enrolled at 6-7 years of age. Participants who previously received Vi-TT received a booster dose of Vi-CRM, while control participants received their first TCV dose. Anti-Vi IgG antibody responses were measured at baseline and 28 days post-vaccination. Safety was assessed through solicited and unsolicited adverse events. This study provides data on durability of TCV immunity and the potential role of booster dosing in endemic settings.

This prospective, open-label interventional study followed children previously enrolled in a Phase 2 randomized controlled trial of Vi-TT administered in infancy. Approximately 5-6 years later, participants were re-contacted and assigned to receive either a booster TCV dose (Vi-CRM) or a first TCV dose depending on prior vaccination status. Immunogenicity was assessed using anti-Vi IgG ELISA assays at baseline and 28 days post-vaccination. Safety outcomes included solicited and unsolicited adverse events and serious adverse events. The study was conducted at a single clinical site in Ouagadougou, Burkina Faso.

Conditions