Evaluating a vaccine to prevent typhoid fever in Ghana

A Cluster-randomised Controlled Phase IV Trial Assessing the Impact of a Vi-Polysaccharide Conjugate Vaccine in Preventing Typhoid Infection in Asante Akim, Ghana (TyVEGHA)

This study is testing a new typhoid vaccine in Ghana to see if it can effectively prevent typhoid fever in different communities.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 23000 (estimated)
• Ages: 9 Months to 15 Years
• Sex: All
• Sponsor: International Vaccine Institute (Academic / other)
• Locations: 1 site (Kumasi, Ashanti)
• Trial ID: NCT04852185 on ClinicalTrials.gov

What this trial studies

This is a cluster-randomized controlled trial assessing the effectiveness of a Vi-Polysaccharide conjugate vaccine in preventing typhoid fever in the Asante Akim region of Ghana. The study involves 80 geographically distinct clusters, where some will receive the typhoid vaccine while others will receive a control vaccine. The primary goal is to determine the vaccine's protection against blood culture-confirmed typhoid infections. Enhanced surveillance will track incidence rates in both intervention and control groups to provide real-world effectiveness data. This information is crucial for improving vaccine uptake in high-burden areas.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy children aged 9 months to less than 16 years living in the study area.

Not a fit: Patients with known allergies to vaccine components or those with ongoing acute or chronic illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the incidence of typhoid fever in high-burden regions, improving public health outcomes.

How similar studies have performed: Other studies have shown success with similar vaccine approaches, indicating potential for effective public health interventions.

Eligibility criteria

Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet the following criteria:

* 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

Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study:

* 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).

Temporary exclusion criteria

* 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

Where this trial is running

Kumasi, Ashanti

• Kwame Nkrumah University of Science and Technology — Kumasi, Ashanti, Ghana (Recruiting)

Study contacts

• Principal investigator: Florian Marks, PhD — University of Cambridge
• Study coordinator: Birkneh T Tadesse, PhD

Conditions Typhoid Fever; Typhoid; Typhoid conjugate vaccine; Cluster randomised trial