Impact of a typhoid vaccine in urban South India
Vellore Typhoid Vaccine Impact Trial
This study is testing whether a new typhoid vaccine can help reduce the number of typhoid fever cases in young people aged 1 to 30 living in urban South India.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 72500 (estimated) |
| Ages | 1 Year to 30 Years |
| Sex | All |
| Sponsor | Christian Medical College, Vellore, India Academic / other |
| Locations | 1 site (Vellore, Tamil Nadu) |
| Trial ID | NCT05500482 on ClinicalTrials.gov |
What this trial studies
This cluster randomised trial will assess the effectiveness of the TyphiBEV typhoid conjugate vaccine in reducing the incidence of typhoid fever among individuals aged 1 to 30 years in a high-burden urban area of South India. The trial will involve 72,000 participants, with half receiving the vaccine at the start and the other half receiving it after two years. Participants will be monitored through stimulated passive surveillance to identify cases of blood-culture confirmed typhoid fever, allowing for a comparison of incidence rates between vaccinated and unvaccinated groups. The findings aim to inform national immunisation policy regarding typhoid vaccines.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 1 to 30 years living in the Vellore area who can provide informed consent or have a guardian who can.
Not a fit: Patients who have received a typhoid vaccine in the past three years or have medical conditions preventing compliance with study requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could significantly reduce the incidence of typhoid fever in high-burden areas, improving public health outcomes.
How similar studies have performed: Similar typhoid conjugate vaccines have shown significant efficacy in other countries, suggesting potential success for this approach in India.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Consent * For adults, 18 years and over - they must be willing and competent to provide informed consent * For those aged under 18 years, the parent/guardian is willing and competent to provide informed consent, and if the participant is 11 to 18 years of age, informed assent will also be sought, * Age: * Between 1 and 30 years (i.e., up to 29 years 364 days) at time of recruitment into the surveillance * Currently living within the study catchment area with no plans to leave the study area in the next 24 months Exclusion Criteria: * For fever surveillance o Medical reasons that prevent the participant from complying with study requirements including follow up and testing during illness * For vaccination * Has received a typhoid vaccine in the previous three years * Is known to have an allergy to any vaccine component * Nursing mothers, Pregnancy or planning pregnancy around vaccination * Receipt of any other vaccine in the past 30 days (temporary exclusion) * Febrile illness in the 24 hours before vaccination (temporary exclusion)
Where this trial is running
Vellore, Tamil Nadu
- Christian Medical College Vellore — Vellore, Tamil Nadu, India (Recruiting)
Study contacts
- Principal investigator: Jacob John, MD PhD — Christian Medical College, Vellore, India
- Study coordinator: Jacob John, MD PhD
- Email: jebu@cmcvellore.ac.in
- Phone: 00919442631628
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.