The goal of this observational study is to learn about the impact of malaria vaccinationon 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 areenrolled 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 ofparticipants with and without iNTS infection to determine if the malaria vaccine protectsagainst iNTS.
- This study builds on existing febrile illnesses surveillance in the Kisantu Health
Zone, which enrolls patients presenting to participating healthcare facilities with
fever.(See specific eligibility criteria)
- For participants eligible to receive the malaria vaccine (6-24 months) and included
in the study at the surveillance sites (presenting with fever), malaria vaccination
status is ascertained with the Expanded Program of Immunization (EPI) card,
Alternatively, a dedicated vaccination registration database that was set-up in the
study catchment area is searched. The study team can also visit participants' house
to verify the EPI vaccination card. R21/Matrix-M malaria vaccine was rolled out in
the Kisantu Health Zone as part of the Expanded Program on Immunizations (DRC
Ministry of Public Health) on 29th of October 2024.
- The laboratory diagnosis of iNTS uses automated blood culture method. Malaria
diagnosis is confirmed with microscopic examination of blood smears. Malaria Rapid
Diagnostic Tests (mRDTs) are also performed for all participants for routine
clinical management and rapid treatment guidance at the healthcare facility level.
For laboratory-confirmed iNTS cases, malaria parasitemia and species specification
is confirmed by Polymerase Chain Reaction (PCR).
- All participants with positive blood culture to iNTS and/or a confirmed malaria
parasitemia receive antibacterial and/or antimalarial treatment in accordance with
national guidelines. Hospitalized cases with confirmed iNTS, with or without malaria
co-infection, are followed until hospital discharge or death. Participants with a
positive blood culture for iNTS and discharged after enrollment are followed every 7
to 9 days until disease resolution (defined as no fever in the past 24 hours),
death, or up to 21 days post-enrollment to assess symptom severity, hospitalization,
and disease outcome.
Biological: R21/Matrix-M malaria vaccine
R21/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.
Inclusion Criteria:
1. 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
2. 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
Institut National de Recherche Biomedicale (INRB)
Kinshasa, Democratic Republic of the Congo
Investigator: Octavie Lunguya, PHD
Contact: +243815181121
octmetila@yahoo.fr
Birkneh Tadesse, MD, PHD
+821098041348
Birkneh.Tadesse@ivi.int
Camille Dauvergne, PharmD, M.S.c
+821091480309
Camille.Dauvergne@ivi.int
Octavie Lunguya, Principal Investigator
Institut National de Recherche Biomedicale