Immunogenicity and Tolerability of Booster Typhoid Conjugate Vaccine (TCV) 5-6 Years After Initial Dose in Children in Burkina Faso
Summary
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.
Timeline
- Start
- 2024-08-17
- Primary completion
- 2024-10-26
- Completion
- 2024-10-26
Publications
- Background Laurens MB, Sirima SB, Rotrosen ET, Siribie M, Tiono A, Ouedraogo A, Liang Y, Jamka LP, Kotloff KL, Neuzil KM. A Phase II, Randomized, Double-blind, Controlled Safety and Immunogenicity Trial of Typhoid Conjugate Vaccine in Children Under 2 Years of Age in Ouagadougou, Burkina Faso: A Methods Paper. Clin Infect Dis. 2019 Mar 7;68(Suppl 2):S59-S66. doi: 10.1093/cid/ciy1104.
- Background Sirima SB, Ouedraogo A, Barry N, Siribie M, Tiono AB, Nebie I, Konate AT, Berges GD, Diarra A, Ouedraogo M, Soulama I, Hema A, Datta S, Liang Y, Rotrosen ET, Tracy JK, Jamka LP, Neuzil KM, Laurens MB. 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. Int J Infect Dis. 2021 Jan;102:517-523. doi: 10.1016/j.ijid.2020.10.103. Epub 2020 Nov 8.
- Background Sirima SB, Ouedraogo A, Barry N, Siribie M, Tiono A, Nebie I, Konate A, Berges GD, Diarra A, Ouedraogo M, Bougouma EC, Soulama I, Hema A, Datta S, Liang Y, Rotrosen ET, Tracy JK, Jamka LP, Oshinsky JJ, Pasetti MF, Neuzil KM, Laurens MB. Safety and immunogenicity of Vi-typhoid conjugate vaccine co-administration with routine 9-month vaccination in Burkina Faso: A randomized controlled phase 2 trial. Int J Infect Dis. 2021 Jul;108:465-472. doi: 10.1016/j.ijid.2021.05.061. Epub 2021 Jun 1.
- Background Ouedraogo A, Diarra A, Nebie I, Barry N, Kabore JM, Tiono AB, Datta S, Liang Y, Mayo I, Oshinsky JJ, Tracy JK, Girmay T, Pasetti MF, Jamka LP, Neuzil KM, Sirima SB, Laurens MB. Durable Anti-Vi IgG and IgA Antibody Responses in 15-Month-Old Children Vaccinated With Typhoid Conjugate Vaccine in Burkina Faso. J Pediatric Infect Dis Soc. 2023 Sep 27;12(9):513-518. doi: 10.1093/jpids/piad058.
- Results Sawadogo JW, Hema A, Diarra A, Kabore JM, Hien D, Kouraogo L, Zou AR, Ouedraogo AZ, Tiono AB, Datta S, Pasetti MF, Neuzil KM, Sirima SB, Ouedraogo A, Laurens MB#. Immunogenicity and tolerability of booster typhoid conjugate vaccine (TCV) five to six years after initial dose in Burkinabe children. medRxiv [Preprint]. 2026 Apr 21. doi:10.64898/2026.04.19.26351224.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vi-CRM | Vaccine | 0.5 ml | Intramuscular |