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

NCT07624175 | Completed Phase 2

• 2 other identifiers: HP-00110239INV 030857
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Typhoid

Keywords

typhoid vaccine; Salmonella Typhi; typhoid fever

Outcome Measures

Primary Outcomes (1)

• Anti-Vi IgG Antibody Response (Immunogenicity)

  Geometric Mean Titers (GMT) and fold-rise in anti-Vi IgG

  Baseline (Day 0) and Day 28 post-vaccination

Secondary Outcomes (4)

• Seroconversion rate

  Day 28

• Solicited adverse events

  Days 0-7

• Unsolicited adverse events

  Days 0-28

• Serious adverse events

  Days 0-28

Study Arms (1)

typhoid conjugate vaccine (TCV)

EXPERIMENTAL

Received one intramuscular dose of Vi-CRM (TYPHIBEV®)

Biological: Vi capsular polysaccharide-CRM197 conjugate vaccine (Vi-CRM), 0.5 mL IM

Interventions

Vi capsular polysaccharide-CRM197 conjugate vaccine (Vi-CRM), 0.5 mL IM BIOLOGICAL

Typhoid conjugate vaccine: Vi capsular polysaccharide conjugated to CRM197 carrier protein, administered as 0.5mL intramuscularly

typhoid conjugate vaccine (TCV)

Eligibility Criteria

• Age: 6 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male or female children previously enrolled in the 2018-2019 Phase 2 typhoid conjugate vaccine trial
• Residence within study area
• Parent/guardian provides informed consent

You may not qualify if:

• Receipt of blood products within 6 months
• Prior typhoid conjugate vaccine receipt outside the study
• Medical condition interfering with evaluation

Sponsors & Collaborators

• Kathleen Neuzil: lead
• Groupe de Recherche Action en Sante: collaborator

Study Sites (1)

Schiphra Protestant Hospital

Ouagadougou, Burkina Faso

Location

Related Publications (5)

• 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.

  PMID: 30845330 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.

  PMID: 33176205 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.

  PMID: 34082090 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.

  PMID: 37589596 BACKGROUND

• 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.

  RESULT

MeSH Terms

Conditions

Typhoid Fever

Condition Hierarchy (Ancestors)

Salmonella Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Participants vaccinated previously at age 9-23 months with either typhoid conjugate vaccine (Vi-TT typhoid conjugate vaccine) or control vaccine (inactivated polio vaccine) as part of a clinical trial receive a dose of typhoid conjugate vaccine (Vi-CRM typhoid conjugate vaccine) as a first or second typhoid conjugate vaccine dose, respectively.

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start: August 17, 2024
• Primary Completion: October 26, 2024
• Study Completion: October 26, 2024
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Upon study publication and for the subsequent 24 months.
• Access Criteria: Persons who submit an approved request via the Vivli platform online will be able to access individual participant data after de-identification.

Locations

BU (1)