Vellore Typhoid Vaccine Impact Trial

NCT ID: NCT05500482

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 72500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-12-31

Brief Summary

This cluster randomised trial will examine the impact of introducing TyphiBEV, a typhoid conjugate vaccine licensed in India, on the incidence of typhoid fever in a high burden urban setting in South India.

Detailed Description

TyphiBEV®, a typhoid conjugate vaccine from Biological E, has been licensed by the Central Drugs Standard Control Organaisation in India based on immunogenicity and safety data. A similar typhoid conjugate vaccine has been demonstrated in large clinical trials to provide 80% vaccine efficacy in Nepal and Bangladesh. The TyphiBEV® has not been similarly evaluated. The demonstration of the impact of a city-scale typhoid conjugate vaccine introduction on the burden of typhoid will aid policy decisions on the use of typhoid conjugate vaccines in the national immunisation program.

After written informed consent, the investigators will establish stimulated passive surveillance in 72,000 individuals between 1 and 30 years of age within the Vellore Demographic Surveillance System to determine the incidence of blood-culture confirmed typhoid fever. Thirty-six thousand surveillance participants between 1 year and 30 years residing in the 30 clusters (areas) randomised to receive the vaccine will receive the vaccine at the beginning of the trial. Those in other areas will receive the same at the end of two years. Using a stimulated passive surveillance approach, those with acute febrile illness will be encouraged to visit study surveillance hospitals. Participants will be evaluated for blood-culture confirmed typhoid fever if they are eligible. The incidence of typhoid among those living in areas assigned to vaccination compared to those whose residence is in areas not designated for vaccination will be used to calculate the impact of the vaccine on disease burden.

Conditions

Typhoid Fever

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Vaccinated arm

Typhoid Conjugate Vaccine (TyphiBEV) 0.5 ml as a single dose given intramuscularly to consenting, eligible residents of vaccine clusters

Group Type: EXPERIMENTAL

Typhoid conjugate Vaccine

Intervention Type: BIOLOGICAL

TyphiBEV is a clear colourless monovalent vaccine containing 25 µg of Typhoid Vi polysaccharide manufactured using the Citrobacter freundii sensu lato3056 (Vi) and is conjugated to CRM 197 as a carrier protein. Sodium chloride and Phosphate buffer are used as a buffering agent in the vaccine formulation with 2-Phenoxyethanol as a preservative.

Control arm

No vaccination in the control clusters

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Typhoid conjugate Vaccine

TyphiBEV is a clear colourless monovalent vaccine containing 25 µg of Typhoid Vi polysaccharide manufactured using the Citrobacter freundii sensu lato3056 (Vi) and is conjugated to CRM 197 as a carrier protein. Sodium chloride and Phosphate buffer are used as a buffering agent in the vaccine formulation with 2-Phenoxyethanol as a preservative.

Intervention Type: BIOLOGICAL

Other Intervention Names

TyphiBEV

Eligibility 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)

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: collaborator

Christian Medical College, Vellore, India

OTHER

Sponsor Role: lead

Responsible Party

Jacob John

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jacob John, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Christian Medical College, Vellore, India

Gagandeep Kang, MD PhD

Role: STUDY_CHAIR

Christian Medical College, Vellore, India

Locations

Christian Medical College Vellore

Vellore, Tamil Nadu, India

Site Status: RECRUITING

Countries

India

Central Contacts

Jacob John, MD PhD

Role: CONTACT

jebu@cmcvellore.ac.in

00919442631628

Facility Contacts

Jacob John, MD PhD

Role: primary

vevact@tyimpact.in

00914162284401

Other Identifiers

14247[INTERVEN]

Identifier Type: -

Identifier Source: org_study_id