Effectiveness of a Typhoid Conjugate Vaccine in DRC

Typhoid Fever Clinical Trial

— TyVECO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05119426
• Other study ID #: 2021-009
• Status: Recruiting
• Phase: Phase 4
• Start date: February 11, 2022
• Est. completion date: December 2024

Study information

• Verified date: April 2023
• Source: International Vaccine Institute
• Contact: Justin Im, MSc
• Phone: +82-10-3296-0711
• Email: justin.im[@]ivi.int
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Months to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Typhoid Fever

Intervention

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.

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	Cerphytoco	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	CS Cederi Madimba	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	CS Kavuaya	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	CS Kilenda	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	CS Kimuisi	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	CS Kinkonko	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	CS Kintanu Etat	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	CS Kipako	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	CS Kipasa	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	CS Kivuangi	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	CS Lemfu	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	CS Ngeba	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	CS Saint Pierre Boko	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	CS Yimbi	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	Gare	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	Kimayala	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	Nkandu 1	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	Nkandu 2	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	Nkandu 3	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	PS Kilemfu Nkanga	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	PS Kongo Nord	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	PS Ngombi Kinsambu	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	Site avancé de Kinsambamba	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	Unadic	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	Wete	Kisantu	Bas-Congo

Sponsors (4)

Lead Sponsor	Collaborator
International Vaccine Institute	Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo, Institute of Tropical Medicine, Belgium, University of Cambridge

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 years
Secondary	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	3 years
Secondary	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	3 years
Secondary	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	3 years
Secondary	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	28 days
Secondary	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	3 years