Evaluation of Typhoid Conjugate Vaccine Effectiveness in Ghana

NCT04852185 | Recruiting Phase 4 DMC

• 1 other identifier: TyVEGHA2020
• Study Type: interventional
• Target: 23,000
• Locations: 1 country
• Sites: 1

Brief Summary

A cluster-randomised controlled Phase IV trial (cRCT) assessing the impact of a Vi-Polysaccharide conjugate vaccine in preventing typhoid infection in Asante Akim, Ghana (TyVEGHA) with a primary endpoint of determining the total protection conferred by single-dose vaccination with Vi-TT against blood culture-confirmed symptomatic S. Typhi infection in the intervention vaccine clusters, compared with the control vaccine clusters.

Conditions

Typhoid Fever

Keywords

Typhoid; Typhoid conjugate vaccine; Cluster randomised trial

Outcome Measures

Primary Outcomes (1)

• Total Protection

  The incidence of blood culture-confirmed symptomatic TF in all vaccine recipients of the intervention clusters, compared with control clusters.

  3 years

Secondary Outcomes (8)

• Safety Assessment

  3 years

• Overall protection

  3 years

• Total protection against severe typhoid.

  3 years

• Total protection against clinical typhoid.

  3 years

• Overall protection against clinical typhoid.

  3 years

Study Arms (2)

Vi-TT Arm

EXPERIMENTAL

A single dose of Vi-TT to children 9 months to 15 years of age.

Biological: Vi-TT

MCV-A arm

ACTIVE COMPARATOR

A single dose of MCV-A vaccine to the comparator group.

Biological: MCV-A vaccine

Interventions

Vi-TT BIOLOGICAL

Single-dose V-TT administered to children and adolescents between the ages of 9 months to 15 years.

Vi-TT Arm

MCV-A vaccine BIOLOGICAL

Single-dose of MCV-A vaccine (a meningococcal vaccine)

MCV-A arm

Eligibility Criteria

• Age: 9 Months - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy participants aged 9 months to \<16 years (i.e., ≤15 years and 364 days) of age at the time of vaccination
• Participants/Parents/legally authorized representative (LAR) who have voluntarily given informed assent (sought from participants aged 12 years to \<16 years) and informed consent
• Participants/Parents/LAR living within study target area at the time of vaccination and willing to follow the study procedures and be available for the entire duration of the study

You may not qualify if:

• Known allergy to any vaccine component
• Self-reported ongoing acute and/or chronic illness
• Any self-reported coagulopathies
• Any medical or social compelling reasons in the judgment of a clinical physician
• Self-reported pregnancy/Positive urine pregnancy test or lactating
• Previous typhoid vaccination in the last 5 years (proven by the presentation of a vaccine card or self-reporting).
• Self-reported fever (elevated tympanic (≥38°C) or axillary temperature (≥37.5°C)) within 24 hours of vaccination
• Self-reported use of antipyretics within 4hours prior to vaccination
• Any other vaccination during the last 4 weeks (proven by the presentation of a vaccine card or self-reporting)
• Girls ≥11 years of age with self-reported irregular menstruation or who do not know their last menstruation date

Sponsors & Collaborators

• International Vaccine Institute: lead
• Kwame Nkrumah University of Science and Technology: collaborator
• University of Cambridge: collaborator
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• Fondation Mérieux: collaborator
• University of Maryland, Baltimore: collaborator

Study Sites (1)

Kwame Nkrumah University of Science and Technology

Kumasi, Ashanti Region, PMB, Ghana

RECRUITING

MeSH Terms

Conditions

Typhoid Fever

Condition Hierarchy (Ancestors)

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

Study Officials

• Florian Marks, PhD

  University of Cambridge

  PRINCIPAL INVESTIGATOR

• Ellis Owusu Dabo, PhD

  Kwame Nkrumah University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Birkneh T Tadesse, PhD

CONTACT

+821098041348; birkneh.tadesse@ivi.int

Thaint Thaint Thwe, MBBS, MSc.

CONTACT

+821037907535; ThaintThaint.Thwe@ivi.int

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participant- and observer-blinded, cluster-randomised controlled Phase IV trial

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: April 21, 2021
• Study Start: August 24, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1)