Typhoid FeverPhase 4TyVECONCT05119426
Effectiveness of a Typhoid Conjugate Vaccine in DRC
A Phase 4 study testing Vi-TT in people with Typhoid Fever, run by International Vaccine Institute at 25 sites in Democratic Republic of the Congo.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 months to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Typhoid Fever
- What is being tested?
- Vi-TT
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48,000 participants
- Where
- 25 sitesDemocratic Republic of the Congo
- Study dates
- 11 Feb 2022to Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 months to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Democratic Republic of the Congo25 sites, 5 recruiting
- Completed
Cerphytoco
Kisantu, Bas-Congo Province
- Completed
CS Cederi Madimba
Kisantu, Bas-Congo Province
- Completed
CS Kavuaya
Kisantu, Bas-Congo Province
- Completed
CS Kilenda
Kisantu, Bas-Congo Province
- Completed
CS Kimuisi
Kisantu, Bas-Congo Province
- Not yet recruiting
CS Kinkonko
Kisantu, Bas-Congo Province
Octavie Lunguya, octmetila@yahoo.fr
- Completed
CS Kintanu Etat
Kisantu, Bas-Congo Province
- Recruiting
CS Kipako
Kisantu, Bas-Congo Province
Octavie Lunguya, octmetila@yahoo.fr
- Not yet recruiting
CS Kipasa
Kisantu, Bas-Congo Province
Octavie Lunguya, octmetila@yahoo.fr
- Completed
CS Kivuangi
Kisantu, Bas-Congo Province
- Not yet recruiting
CS Lemfu
Kisantu, Bas-Congo Province
Octavie Lunguya, octmetila@yahoo.fr
- Recruiting
CS Ngeba
Kisantu, Bas-Congo Province
Octavie Lunguya, octmetila@yahoo.fr
- Completed
CS Saint Pierre Boko
Kisantu, Bas-Congo Province
- Completed
CS Yimbi
Kisantu, Bas-Congo Province
- Completed
Gare
Kisantu, Bas-Congo Province
- Completed
Kimayala
Kisantu, Bas-Congo Province
- Completed
Nkandu 1
Kisantu, Bas-Congo Province
- Completed
Nkandu 2
Kisantu, Bas-Congo Province
- Completed
Nkandu 3
Kisantu, Bas-Congo Province
- Completed
PS Kilemfu Nkanga
Kisantu, Bas-Congo Province
- Completed
PS Kongo Nord
Kisantu, Bas-Congo Province
- Completed
PS Ngombi Kinsambu
Kisantu, Bas-Congo Province
- Completed
Site avancé de Kinsambamba
Kisantu, Bas-Congo Province
- Completed
Unadic
Kisantu, Bas-Congo Province
- Completed
Wete
Kisantu, Bas-Congo Province
About this study
Official title: 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.
Read the 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.
- Conditions
- Typhoid Fever
- Being tested
- Vi-TT
- Keywords
- Typhoid conjugate vaccine, Vaccine effectiveness, Mass vaccination campaign, Democratic Republic of Congo (DRC)
- Medical subject headings
- Typhoid Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vi-TTBiological
Also called Typbar TCV
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.
| Study group | Role | What they receive |
|---|---|---|
| Vi-TT | Experimental | Single dose of Vi-TT to children 9 months to <16 years of age Receives: Biological: Vi-TT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Direct vaccine effectiveness of Typbar-TCV®
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
Measured: 3 years
Secondary outcomes (5)
Overall vaccine effectiveness of Typbar-TCV®
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
Measured: 3 years
Total vaccine effectiveness of Typbar-TCV®
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
Measured: 3 years
Indirect vaccine effectiveness of Typbar-TCV®
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
Measured: 3 years
Safety profile of Typbar-TCV®
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
Measured: 28 days
Feasibility of a single-dose Typbar-TCV® mass campaign in Kisantu, DRC
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start11 Feb 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Typhoid FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Vaccine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche Biomedicale (INRB), University of Cambridge, Institute of Tropical Medicine, Belgium
- Responsible party
- Sponsor
- Investigators
- Florian Marks, PhD, Principal investigator, University of CambridgeOctavie Lunguya, PhD, Principal investigator, Institut National de Research Biomédicale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119426
- Sponsor's protocol ID
- 2021-009
- Acronym
- TyVECO
- Status last verified
- Apr 2023
- First submitted
- 18 Oct 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing can be considered on a case-by-case basis considering the intended use and impact.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05119426
- Acronym / sponsor ID
- TyVECO / 2021-009
- Conditions
- Typhoid Fever
- Keywords
- Typhoid conjugate vaccine, Vaccine effectiveness, Mass vaccination campaign, Democratic Republic of Congo (DRC)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48,000 participants (estimated)
- Lead sponsor
- International Vaccine InstituteUniversity, hospital or other
- Collaborators
- Institut National de Recherche Biomedicale (INRB), University of Cambridge, Institute of Tropical Medicine, Belgium
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vi-TT | Experimental | Biological: Vi-TTSingle dose of Vi-TT to children 9 months to <16 years of age |
Who may qualify
- Ages
- 9 months to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vi-TTAlso: Typbar TCVSingle 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. | Biological | Vi-TT |
Primary outcome
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
5 secondary outcomes
Overall vaccine effectiveness of Typbar-TCV®
Time frame: 3 years
Total vaccine effectiveness of Typbar-TCV®
Time frame: 3 years
Indirect vaccine effectiveness of Typbar-TCV®
Time frame: 3 years
Safety profile of Typbar-TCV®
Time frame: 28 days
Feasibility of a single-dose Typbar-TCV® mass campaign in Kisantu, DRC
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No. Sharing can be considered on a case-by-case basis considering the intended use and impact.
Related trials for Typhoid Fever
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Curcumin Extract Added to Ciprofloxacin for Typhoid Carriers Among Food Handlers of the Free Nutritious Meal Program
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Opportunistic Pneumococcal Immunisation Trial in MALnutrition
Severe Acute Malnutrition in Childhood, Pneumococcal Disease
Active, not recruitingPhase 3
Clinical Efficacy of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Age 9 Months Through 12 Years in Blantyre, Malawi
Typhoid
RecruitingPhase 4
CVD 38000: Study of Responses to Vaccination With Typhoid and/or Cholera
Typhoid and/or Cholera Vaccination
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian Marks, PhD principal investigator
University of Cambridge
Octavie Lunguya, PhD principal investigator
Institut National de Research Biomédicale
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vi-TT in people with Typhoid Fever, run by International Vaccine Institute at 25 sites in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justin Im, MSc (+82-10-3296-0711, justin.im@ivi.int), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Direct vaccine effectiveness of Typbar-TCV® (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.