Clinical trial NCT05119426: Effectiveness of a Typhoid Conjugate Vaccine in DRC
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Typhoid Fever
Keywords: Typhoid conjugate vaccine
Vaccine effectiveness
Mass vaccination campaign
Democratic Republic of Congo (DRC)
Lead sponsor: International Vaccine Institute
Sponsor class: OTHER
Collaborators: name: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
name: University of Cambridge
name: Institute of Tropical Medicine, Belgium
First posted: 2021-11-15
Enrollment: 48000
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Direct vaccine effectiveness of Typbar-TCV®
timeFrame: 3 years
Secondary outcomes:
measure: Overall vaccine effectiveness of Typbar-TCV®
timeFrame: 3 years
measure: Total vaccine effectiveness of Typbar-TCV®
timeFrame: 3 years
measure: Indirect vaccine effectiveness of Typbar-TCV®
timeFrame: 3 years
measure: Safety profile of Typbar-TCV®
timeFrame: 28 days
measure: Feasibility of a single-dose Typbar-TCV® mass campaign in Kisantu, DRC
timeFrame: 3 years
Other outcomes:
Locations:
city: Kisantu
country: Congo, The Democratic Republic of the
facility: Cerphytoco
state: Bas-Congo
city: Kisantu
country: Congo, The Democratic Republic of the
facility: CS Cederi Madimba
state: Bas-Congo
city: Kisantu
country: Congo, The Democratic Republic of the
facility: CS Kavuaya
state: Bas-Congo
city: Kisantu
country: Congo, The Democratic Republic of the
facility: CS Kilenda
state: Bas-Congo
city: Kisantu
country: Congo, The Democratic Republic of the
facility: CS Kimuisi
state: Bas-Congo
city: Kisantu
country: Congo, The Democratic Republic of the
facility: CS Kinkonko
state: Bas-Congo
city: Kisantu
country: Congo, The Democratic Republic of the
facility: CS Kintanu Etat
state: Bas-Congo
city: Kisantu
country: Congo, The Democratic Republic of the
facility: CS Kipako
state: Bas-Congo
city: Kisantu
country: Congo, The Democratic Republic of the
facility: CS Kipasa
state: Bas-Congo
city: Kisantu
country: Congo, The Democratic Republic of the
facility: CS Kivuangi
state: Bas-Congo
city: Kisantu
country: Congo, The Democratic Republic of the
facility: CS Lemfu
state: Bas-Congo
city: Kisantu
country: Congo, The Democratic Republic of the
facility: CS Ngeba
state: Bas-Congo
city: Kisantu
country: Congo, The Democratic Republic of the
facility: CS Saint Pierre Boko
state: Bas-Congo
city: Kisantu
country: Congo, The Democratic Republic of the
facility: CS Yimbi
state: Bas-Congo
city: Kisantu
country: Congo, The Democratic Republic of the
facility: Gare
state: Bas-Congo
city: Kisantu
country: Congo, The Democratic Republic of the
facility: Kimayala
state: Bas-Congo
city: Kisantu
country: Congo, The Democratic Republic of the
facility: Nkandu 1
state: Bas-Congo
city: Kisantu
country: Congo, The Democratic Republic of the
facility: Nkandu 2
state: Bas-Congo
city: Kisantu
country: Congo, The Democratic Republic of the
facility: Nkandu 3
state: Bas-Congo
city: Kisantu
country: Congo, The Democratic Republic of the
facility: PS Kilemfu Nkanga
state: Bas-Congo
city: Kisantu
country: Congo, The Democratic Republic of the
facility: PS Kongo Nord
state: Bas-Congo
city: Kisantu
country: Congo, The Democratic Republic of the
facility: PS Ngombi Kinsambu
state: Bas-Congo
city: Kisantu
country: Congo, The Democratic Republic of the
facility: Site avancé de Kinsambamba
state: Bas-Congo
city: Kisantu
country: Congo, The Democratic Republic of the
facility: Unadic
state: Bas-Congo
city: Kisantu
country: Congo, The Democratic Republic of the
facility: Wete
state: Bas-Congo
Study officials:
affiliation: University of Cambridge
name: Florian Marks, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut National de Research Biomédicale
name: Octavie Lunguya, PhD
role: PRINCIPAL_INVESTIGATOR
References: