Do malaria vaccines lower the risk of invasive non-typhoidal Salmonella in young children?
Effectiveness of Malaria Vaccines in Reducing the Risk of Invasive Non-Typhoidal Salmonella Disease (VINS)
This study will see if the R21/Matrix-M malaria vaccine lowers the chance of invasive non-typhoidal Salmonella disease in children under 5 who come to health facilities with fever in the Kisantu Health Zone (DRC).
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Sex | All |
| Sponsor | International Vaccine Institute Academic / other |
| Locations | 1 site (Kinshasa) |
| Trial ID | NCT07416461 on ClinicalTrials.gov |
What this trial studies
This is an observational, test-negative case-control study built on ongoing fever surveillance in the Kisantu Health Zone. Children and other patients who present to participating healthcare facilities with fever are tested for malaria (mRDT, microscopy, PCR) and invasive non-typhoidal Salmonella (automated blood culture). Vaccination status for R21/Matrix-M is confirmed using EPI cards, a local vaccination registry, or home visits where needed, and analyses compare vaccination rates in iNTS-positive versus iNTS-negative patients. All participants with confirmed infections receive treatment per national guidelines.
Who should consider this trial
Good fit: Ideal candidates are children under age 5 living in the Kisantu Health Zone who present to participating health facilities with fever, particularly those age-eligible for R21/Matrix-M (about 6–24 months) with verifiable vaccination records.
Not a fit: People who do not live in the Kisantu catchment area, those who do not present with fever at participating sites, and individuals not age-eligible for or without documented malaria vaccination are unlikely to receive direct benefit from this observational work.
Why it matters
Potential benefit: If successful, malaria vaccination could lower the number of iNTS cases and related hospitalizations and deaths among young children in malaria-endemic areas.
How similar studies have performed: Malaria vaccines such as R21/Matrix-M have shown promising protection against malaria in prior trials, but using malaria vaccination specifically to reduce invasive non-typhoidal Salmonella is a novel question with limited prior direct evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Kinshasa
- Institut National de Recherche Biomedicale (INRB) — Kinshasa, Democratic Republic of the Congo (Recruiting)
Study contacts
- Principal investigator: Octavie Lunguya — Institut National de Recherche Biomedicale
- Study coordinator: Birkneh Tadesse, MD, PHD
- Email: Birkneh.Tadesse@ivi.int
- Phone: +821098041348
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.