Effectiveness of a Typhoid Conjugate Vaccine in DRC
- Conditions
- Typhoid Fever
- Interventions
- Biological: Vi-TT
- Registration Number
- NCT05119426
- Lead Sponsor
- International Vaccine Institute
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 48000
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vi-TT Vi-TT Single dose of Vi-TT to children 9 months to \<16 years of age
- Primary Outcome Measures
Name Time Method Direct vaccine effectiveness of Typbar-TCV® 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
- Secondary Outcome Measures
Name Time Method Safety profile of Typbar-TCV® 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
Feasibility of a single-dose Typbar-TCV® mass campaign in Kisantu, DRC 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
Overall vaccine effectiveness of Typbar-TCV® 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
Total vaccine effectiveness of Typbar-TCV® 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
Indirect vaccine effectiveness of Typbar-TCV® 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
Trial Locations
- Locations (25)
CS Kavuaya
🇨🇩Kisantu, Bas-Congo, Congo, The Democratic Republic of the
CS Kimuisi
🇨🇩Kisantu, Bas-Congo, Congo, The Democratic Republic of the
CS Kintanu Etat
🇨🇩Kisantu, Bas-Congo, Congo, The Democratic Republic of the
CS Yimbi
🇨🇩Kisantu, Bas-Congo, Congo, The Democratic Republic of the
CS Lemfu
🇨🇩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
CS Kilenda
🇨🇩Kisantu, Bas-Congo, Congo, The Democratic Republic of the
CS Kinkonko
🇨🇩Kisantu, Bas-Congo, Congo, The Democratic Republic of the
CS Kipasa
🇨🇩Kisantu, Bas-Congo, Congo, The Democratic Republic of the
CS Ngeba
🇨🇩Kisantu, Bas-Congo, Congo, The Democratic Republic of the
Gare
🇨🇩Kisantu, Bas-Congo, Congo, The Democratic Republic of the
CS Cederi Madimba
🇨🇩Kisantu, Bas-Congo, Congo, The Democratic Republic of the
Nkandu 1
🇨🇩Kisantu, Bas-Congo, Congo, The Democratic Republic of the
Site avancé de Kinsambamba
🇨🇩Kisantu, Bas-Congo, Congo, The Democratic Republic of the
Cerphytoco
🇨🇩Kisantu, Bas-Congo, Congo, The Democratic Republic of the
CS Kipako
🇨🇩Kisantu, Bas-Congo, Congo, The Democratic Republic of the
CS Saint Pierre Boko
🇨🇩Kisantu, Bas-Congo, Congo, The Democratic Republic of the
Kimayala
🇨🇩Kisantu, Bas-Congo, Congo, The Democratic Republic of the
PS Kilemfu Nkanga
🇨🇩Kisantu, Bas-Congo, Congo, The Democratic Republic of the
Unadic
🇨🇩Kisantu, Bas-Congo, Congo, The Democratic Republic of the
Wete
🇨🇩Kisantu, Bas-Congo, Congo, The Democratic Republic of the
Nkandu 2
🇨🇩Kisantu, Bas-Congo, Congo, The Democratic Republic of the
CS Kivuangi
🇨🇩Kisantu, Bas-Congo, Congo, The Democratic Republic of the
Nkandu 3
🇨🇩Kisantu, Bas-Congo, Congo, The Democratic Republic of the