NCT05562102

TyVECO: Surveillance Protocol

An Open-label Effectiveness Study of a Typhoid Conjugate Vaccine in Kisantu, Democratic Republic of Congo (TyVECO) - Step 3: Surveillance Protocol

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 48,000 (estimated)
• Sponsor: International Vaccine Institute · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

In Kisantu Health Zone, approximate population 200,000, fever surveillance will be implemented in 8 health centers and 1 tertiary hospital. Individuals presenting to one of these study facilities with acute fever or history of fever or individuals presenting with suspicion of intestinal perforation irrespective of fever status, will be considered for enrollment. Following consent, blood samples (between 2.5 ml for children and 22 ml for adults) will be collected from eligible subjects and demographic and clinical information will be recorded in study forms at the time of enrollment at study health centers and hospitals. Peritoneal fluid and ileal tissue samples will be collected from surgical patients where possible. Biological specimens will be used for various testing, including microbiological culture of blood, tissue and peritoneal fluid for confirmation of bacterial growth, malaria diagnostics (microscopy and rapid testing), and storage of tissue samples for pathological investigation, and biobanking. Hospitalized patients will be followed-up to track clinical outcomes for the duration of hospitalization.

Conditions

• Typhoid Fever
• Intestinal Perforation

Interventions

Type	Name	Description
BIOLOGICAL	Typbar-TCV, Bharat Biotech	Typhoid conjugate vaccine

Timeline

• Start date: 2021-08-09
• Primary completion: 2024-03-31
• Completion: 2024-03-31
• First posted: 2022-09-30
• Last updated: 2022-09-30

Locations

9 sites across 1 country: Democratic Republic of the Congo