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

May 28, 2026 updated by: Kathleen Neuzil

Immunogenicity and Tolerability of Typhoid Conjugate Vaccine (TCV) 5-6 Years After Routine Vaccines Administered With or Without TCV Among Children Younger Than 2 Years in Ouagadougou, Burkina Faso

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Burkina Faso
      • Ouagadougou, Burkina Faso
        • Schiphra Protestant Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Receipt of blood products within 6 months
  • Prior typhoid conjugate vaccine receipt outside the study
  • Medical condition interfering with evaluation
  • Acute illness or fever prior to vaccination (temporary exclusion)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: typhoid conjugate vaccine (TCV)
Received one intramuscular dose of Vi-CRM (TYPHIBEV®)
Biological: Vi capsular polysaccharide-CRM197 conjugate vaccine (Vi-CRM), 0.5 mL IM
Typhoid conjugate vaccine: Vi capsular polysaccharide conjugated to CRM197 carrier protein, administered as 0.5mL intramuscularly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-Vi IgG Antibody Response (Immunogenicity)
Time Frame: Baseline (Day 0) and Day 28 post-vaccination
Geometric Mean Titers (GMT) and fold-rise in anti-Vi IgG
Baseline (Day 0) and Day 28 post-vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroconversion rate
Time Frame: Day 28
Proportion of participants achieving ≥4-fold increase in anti-Vi IgG
Day 28
Solicited adverse events
Time Frame: Days 0-7
Local and systemic adverse events within 7 days post-vaccination
Days 0-7
Unsolicited adverse events
Time Frame: Days 0-28
Any non-solicited adverse events
Days 0-28
Serious adverse events
Time Frame: Days 0-28
Any serious adverse events
Days 0-28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kathleen Neuzil

Collaborators

Groupe de Recherche Action en Sante

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2024

Primary Completion (Actual)

October 26, 2024

Study Completion (Actual)

October 26, 2024

Study Registration Dates

First Submitted

May 28, 2026

First Submitted That Met QC Criteria

May 28, 2026

First Posted (Actual)

June 3, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00110239
  • INV 030857 (Other Grant/Funding Number: Gates Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data will be available, after de-identification, via the Vivli platform upon approved request.

IPD Sharing Time Frame

Upon study publication and for the subsequent 24 months.

IPD Sharing Access Criteria

Persons who submit an approved request via the Vivli platform online will be able to access individual participant data after de-identification.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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