Effectiveness of Malaria Vaccines in Reducing the Risk of Invasive Non-typhoidal Salmonella Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorInternational Vaccine Institute
About this trial
The goal of this observational study is to learn about the impact of malaria vaccination on the risk of invasive non-typhoidal Salmonella disease in children below the age of 5. Eligible participants residing in the Kisantu Health Zone (DRC) and presenting fever are enrolled in healthcare facilities and tested for malaria and iNTS. Using a case-control (test-negative) design, the researchers will look at the malaria vaccination status of participants with and without iNTS infection to determine if the malaria vaccine protects against iNTS.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with objective fever of at least 38.0°C tympanic or 37.5 °C axillary OR
Patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with reported fever ≥3 consecutive days within 7 days of presentation
Disqualifiers
None
Trial population
Though only children 6-24 months of age are eligible to receive R21/Matrix-M, patients of all age groups presenting with fever at participating sites will be monitored for malaria and iNTS.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
R21/Matrix-M malaria vaccine
Biological/VaccineR21/Matrix-M malaria vaccination was introduced by DRC Ministry of Public Health in the Expanded Program on Immunizations on 29th of October 2024. Children aged 6 months to 24 months are eligible to receive the vaccine. Vaccination follows a 4 doses schedule: a first dose administered between 6 and 11 months of age, a second dose one month after the first dose, a third dose one month after the second dose and a booster dose seven months after the third dose.
Treatment groups
10,000 Participants
are divided into 2 treatment groupsGroup A: Age-eligible children who received the R21/Matrix-M Malaria Vaccine.1 intervention
Group B: Age-eligible children who were not vaccinated against malaria.0 interventions
Trial outcomes
Primary outcomes
1
Blood culture-confirmed iNTS disease (including malaria co-infections) in participants who received complete malaria vaccination vs. unvaccinated participants.
Among individuals seeking care for symptoms consistent with clinical malaria/iNTS, those who have received the full recommended regimen of the R21/Matrix-M malaria vaccine will have a 1.00 - 0.38 or lower odds of blood-culture confirmed iNTS.
Time frame
At presentation (enrollment)Secondary outcomes
1
Blood culture-confirmed iNTS disease (including malaria co-infections) in participants who received any dose of malaria vaccine vs. unvaccinated participants.
Among individuals seeking care for symptoms consistent with clinical malaria/iNTS, those who have received any dose of the R21/Matrix-M malaria vaccine will have a 1.00 - 0.19 or lower odds of blood-culture confirmed iNTS.
Time frame
At presentation (enrollment)2
Culture-confirmed iNTS disease (including malaria co-infections) in participants with at least one severity feature and who received complete malaria vaccination vs. unvaccinated participants.
Among individuals seeking care for symptoms consistent with clinical malaria/iNTS and meeting the definition for severe disease at first presentation to the enrolling healthcare facility, those who have received the full recommended regimen of the R21/Matrix-M malaria vaccine will have a 1.00 - 0.57 or lower odds of blood-culture confirmed iNTS.
Time frame
At presentation (enrollment)3
Blood culture-confirmed iNTS disease (including malaria co-infections) in participants with at least one severity feature and who received any dose of the malaria vaccine vs. unvaccinated participants.
Among individuals seeking care for symptoms consistent with clinical malaria/iNTS and meeting the definition for severe disease at first presentation to the enrolling healthcare facility, those who have received any dose of the R21/Matrix-M malaria vaccine will have a 1.00 - 0.38 or lower odds of blood-culture confirmed iNTS.
Time frame
At presentation (enrollment)4
mRDT, blood smear and/or PCR-confirmed malaria disease, including severe malaria cases, with or without culture-confirmed iNTS disease, in participants who received complete malaria vaccination vs. unvaccinated participants
Among individuals seeking care for symptoms consistent with clinical malaria/iNTS, those who have received the full recommended regimen of the R21/Matrix-M malaria vaccine will have a 1.00 - 0.75 or lower odds of test-positive malaria infection.
Time frame
At presentation (enrollment)Sponsors and contacts
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Source ClinicalTrials.gov