Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05562102
Acronym
TyVECO
Enrollment
48000
Registered
2022-09-30
Start date
2021-08-09
Completion date
2024-03-31
Last updated
2022-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal Perforation, Typhoid Fever

Brief 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.

Interventions

BIOLOGICALTypbar-TCV, Bharat Biotech

Typhoid conjugate vaccine

Sponsors

International Vaccine Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

At health center: 1. Patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with objective fever of at least 38.0°C tympanic or 37.5 °C axillary OR 2. Patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with reported fever ≥3 consecutive days within 7 days of presentation At Hospital: 1. Suspicion of intestinal perforation/peritonitis due to typhoid fever requiring surgery for patients living in and outside the catchment area (even in the absence of laboratory confirmation) OR 2. Patients living in the catchment area of the hospital with invasive salmonellosis confirmed through blood-culture surveillance embedded in routine patient cares

Exclusion criteria

* Individuals who do not provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
Typhoid feverThree years from the time of vaccinationBlood culture confirmed infection with Salmonella typhi

Countries

Democratic Republic of the Congo

Contacts

Primary ContactOctavie Lungaya, PhD
octmetila@yahoo.fr+243-815-181-121
Backup ContactJustin Im, PhD
justin.im@ivi.int+82-10-3296-0711

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026