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OpenTrials
Completed

NCT Number: NCT07624175

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

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Key information

Conditions

Typhoid Bacterial Infections Bacterial Infections and Mycoses Enterobacteriaceae Infections Gram-Negative Bacterial Infections Infections Salmonella Infections Typhoid Fever

Age range

6 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Schiphra Protestant Hospital

Ouagadougou, Burkina Faso

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Seroconversion rate

    Time frame: Day 28

    Proportion of participants achieving ≥4-fold increase in anti-Vi IgG

  2. Solicited adverse events

    Time frame: Days 0-7

    Local and systemic adverse events within 7 days post-vaccination

  3. Unsolicited adverse events

    Time frame: Days 0-28

    Any non-solicited adverse events

  4. Serious adverse events

    Time frame: Days 0-28

    Any serious adverse events

Sponsors and collaborators

Lead sponsor

Kathleen Neuzil

Other

Collaborators

  • Groupe de Recherche Action en Sante

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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