Effectiveness of a Typhoid Conjugate Vaccine in DRC (TyVECO)

April 16, 2023 updated by: International Vaccine Institute

An Open-label Effectiveness Study of a Typhoid Conjugate Vaccine in Kisantu, Democratic Republic of Congo (TyVECO) - Step 2: Typhoid Conjugate Vaccine (TCV) Mass-vaccination Campaign

This is a prospective cohort evaluation of vaccine effectiveness of a single dose of Typbar-TCV® against symptomatic blood culture-confirmed typhoid fever when administered through a mass vaccination campaign to children 9 months to <16 years of age in Kisantu, DRC.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is conducted in Kisantu, DRC and is comprised of a mass vaccination campaign of children aged 9 months to <16 years with a single dose of Typbar-TCV® and a concomitant surveillance study to assess the incidence of culture-confirmed typhoid fever in the population during a period of three years following vaccination. Safety events will be monitored for 30 minutes following vaccination for all participants. In a subset of age-eligible participants living in the study area, the investigators will assess local and systemic solicited adverse events/adverse reactions and unsolicited adverse events occurring within the first 7 days post-vaccination and unsolicited and serious adverse events within 28 days post-vaccination. A population census will be conducted at baseline to enumerate and characterize the population under study and demographic information will be collected to allow for minimization of potential sources of bias during analysis. An interim censuses and a census at study closure will be carried out to update population information.

The investigators hypothesize that the Typbar-TCV® vaccine is effective in large scale vaccination campaigns, thereby lowering the incidence of blood-culture confirmed typhoid fever in children. Lessons and experiences on vaccination feasibility and uptake will be important for informing TCV introduction across the African continent.

Study Type

Interventional

Enrollment (Anticipated)

48000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Megan Carey, MSPH
  • Phone Number: +31 6 29426802
  • Email: mec82@cam.ac.uk

Study Locations

  • Congo, The Democratic Republic of the
    • Bas-Congo
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Completed
        • Cerphytoco
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Completed
        • CS Cederi Madimba
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Completed
        • CS Kavuaya
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Completed
        • CS Kilenda
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Completed
        • CS Kimuisi
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Completed
        • CS Kintanu Etat
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Completed
        • CS Kivuangi
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Completed
        • CS Saint Pierre Boko
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Completed
        • CS Yimbi
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Completed
        • Gare
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Completed
        • Kimayala
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Completed
        • NKANDU 1
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Completed
        • Nkandu 2
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Completed
        • Nkandu 3
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Completed
        • PS Kilemfu Nkanga
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Completed
        • PS Kongo Nord
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Completed
        • PS Ngombi Kinsambu
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Completed
        • Site avancé de Kinsambamba
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Completed
        • Unadic
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Completed
        • Wete

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 15 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Parent/guardian willing and able to provide informed consent; assent will be sought for participants between 12 and <16 years of age
  • Resident of the defined study area, Kisantu Health Zone at the time of vaccination
  • Age between 9 months and <16 years (i.e., ≤15 years and 364 days) on the day of vaccination

Exclusion Criteria:

  • The participant has a known allergy to any of the vaccine components,
  • Any medical reason perceived to increase risk to health posed by vaccination as judged by a medical professional
  • Self-reported pregnancy in females greater or equal to 11 years of age who have reported menarche

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vi-TT
Single dose of Vi-TT to children 9 months to <16 years of age
Biological: Vi-TT
Single dose of vaccine administered through a mass vaccine campaign to children between 9 months and <16 years of age. The campaign will emulate vaccine delivery as would be administered in a local mass vaccination campaign.
Other Names:
  • Typbar TCV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Direct vaccine effectiveness of Typbar-TCV®
Time Frame: 3 years
Comparison of incidence of blood culture confirmed Salmonella Typhi infection in participants 9 months to <16 years of age vaccinated with a single dose of Typbar-TCV® delivered through a mass vaccination campaign and unvaccinated participants 9 months to <16 years of ageSalmonella Typhi isolated from blood specimens using conventional microbiological techniques
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall vaccine effectiveness of Typbar-TCV®
Time Frame: 3 years
Comparison of incidence of blood culture confirmed Salmonella Typhi infection in all individuals 9 months to <16 years of age residing in clusters with lowest vaccine coverage (delineated virtually using GIS data) and all individuals 9 months to <16 years of age residing in clusters with highest vaccine coverage
3 years
Total vaccine effectiveness of Typbar-TCV®
Time Frame: 3 years
Comparison of the incidence of blood culture confirmed Salmonella Typhi infection in vaccinated individuals 9 months to <16 years of age residing in clusters with highest vaccine coverage (delineated virtually using GIS data) versus unvaccinated individuals 9 months to <16 years of age residing in clusters with lowest vaccine coverage
3 years
Indirect vaccine effectiveness of Typbar-TCV®
Time Frame: 3 years
Comparison of the incidence of blood culture confirmed Salmonella Typhi infection in unvaccinated individuals 9 months to <16 years residing in clusters with lowest levels of vaccine coverage (delineated virtually using GIS data) versus unvaccinated individuals 9 months to <16 years of age residing in clusters with highest levels of vaccine coverage
3 years
Safety profile of Typbar-TCV®
Time Frame: 28 days
Proportion of participants developing local and systemic solicited adverse events/adverse reactions and unsolicited adverse events within the first 7 days post-vaccination in a subset of vaccinees and unsolicited and serious adverse events within 28 days post-vaccination
28 days
Feasibility of a single-dose Typbar-TCV® mass campaign in Kisantu, DRC
Time Frame: 3 years
Descriptive report assessing both the scientific feasibility, including the ability of the study team to measure the above-named objectives, and operational feasibility, focusing on logistical aspects of the study conduct
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Vaccine Institute

Collaborators

University of Cambridge
Institute of Tropical Medicine, Belgium
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

Investigators

  • Principal Investigator: Florian Marks, PhD, University of Cambridge
  • Principal Investigator: Octavie Lunguya, PhD, Institut National de Research Biomédicale

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2022

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

October 18, 2021

First Submitted That Met QC Criteria

November 12, 2021

First Posted (Actual)

November 15, 2021

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 16, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Sharing can be considered on a case-by-case basis considering the intended use and impact.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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