The Typhoid Fever Surveillance in Africa Program (TSAP): Clinical, Diagnostic, and Epidemiological Methodologies.
Vera von Kalckreuth, Frank Konings, Peter Aaby...
https://pubmed.ncbi.nlm.nih.gov/26933028Actively Recruiting
All Genders
ID07416461
Effectiveness of Malaria Vaccines in Reducing the Risk of Invasive Non-Typhoidal Salmonella Disease (VINS)
Led by International Vaccine Institute · Updated on 2026-02-18
10000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying children under the age of 5 living in the Kisantu Health Zone of the Democratic Republic of Congo to understand how malaria vaccination affects the risk of invasive non-typhoidal Salmonella (iNTS) disease. This observational study aims to compare the malaria vaccination status of children with and without iNTS infection to see if the malaria vaccine offers protection against this serious bacterial infection. The study uses a case-control design to analyze these relationships. The intervention under study is the R21/Matrix-M malaria vaccine, which was introduced in the Expanded Program on Immunizations on October 29, 2024. Children between 6 and 24 months old are eligible for vaccination, which includes four doses: the first dose between 6 and 11 months of age, followed by a second dose one month later, a third dose one month after that, and a booster dose seven months after the third dose. Participants are grouped based on their vaccination status, including those who received all four doses, partial doses, or no vaccination. Participants presenting with fever at healthcare facilities are tested for malaria and iNTS using blood cultures, microscopic blood smears, rapid diagnostic tests, and PCR for confirmation. Those diagnosed with iNTS and/or malaria receive treatment according to national guidelines and are monitored until recovery or up to 21 days after enrollment. The study measures include confirmed iNTS infection rates in vaccinated versus unvaccinated children and the severity of infections. Follow-up assessments track disease outcomes and resolution of symptoms.
CONDITIONS
Brief Title
Effectiveness of Malaria Vaccines in Reducing the Risk of Invasive Non-typhoidal Salmonella Disease
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- 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
- Patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with reported fever of 3 or more consecutive days within 7 days of presentation
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) at healthcare facility when presenting with fever
Surveillance
Duration - Up to 2 years
Participants who present with fever are observed through febrile illness surveillance including malaria vaccination status verification and diagnostic testing for invasive non-typhoidal Salmonella (iNTS) and malaria.
Visits occur when participants present with febrile illness at healthcare facilities; additional home visits may occur for vaccination status verification
Monitoring
Duration - Up to 21 days post-enrollment
Participants with confirmed iNTS infection and/or malaria infection are monitored for disease progression and outcomes, including hospitalization follow-up until discharge or death.
Weekly visits every 7 to 9 days until disease resolution, death, or 21 days post-enrollment
Trial Site Locations
Total: 1 location
1
Institut National de Recherche Biomedicale (INRB)
Kinshasa, Democratic Republic of the Congo
Actively Recruiting
Loading map...
Research Team
B
Birkneh Tadesse, MD, PHD
C
Camille Dauvergne, PharmD, M.S.c
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Typhoid conjugate vaccine effectiveness in Malawi: evaluation of a test-negative design using randomised, controlled clinical trial data.
Yuanyuan Liang, Amanda J Driscoll, Priyanka D Patel...
https://pubmed.ncbi.nlm.nih.gov/36442498Modeling the Potential for Vaccination to Diminish the Burden of Invasive Non-typhoidal Salmonella Disease in Young Children in Mali, West Africa.
Kristin Bornstein, Laura Hungerford, David Hartley...
https://pubmed.ncbi.nlm.nih.gov/28182657Safety and efficacy of malaria vaccine candidate R21/Matrix-M in African children: a multicentre, double-blind, randomised, phase 3 trial.
Mehreen S Datoo, Alassane Dicko, Halidou Tinto...
https://pubmed.ncbi.nlm.nih.gov/38310910Immunological bases of increased susceptibility to invasive nontyphoidal Salmonella infection in children with malaria and anaemia.
Tonney S Nyirenda, Wilson L Mandala, Melita A Gordon...
https://pubmed.ncbi.nlm.nih.gov/29248635The iron link between malaria and invasive non-typhoid Salmonella infections.
Susanne van Santen, Quirijn de Mast, Dorine W Swinkels...
https://pubmed.ncbi.nlm.nih.gov/23601932Invasive bacterial co-infection in African children with Plasmodium falciparum malaria: a systematic review.
James Church, Kathryn Maitland
https://pubmed.ncbi.nlm.nih.gov/24548672Epidemiology, Clinical Presentation, Laboratory Diagnosis, Antimicrobial Resistance, and Antimicrobial Management of Invasive Salmonella Infections.
John A Crump, Maria Sjölund-Karlsson, Melita A Gordon...
https://pubmed.ncbi.nlm.nih.gov/26180063The Relationship Between Invasive Nontyphoidal Salmonella Disease, Other Bacterial Bloodstream Infections, and Malaria in Sub-Saharan Africa.
Se Eun Park, Gi Deok Pak, Peter Aaby...
https://pubmed.ncbi.nlm.nih.gov/26933016Association Between Malaria and Invasive Nontyphoidal Salmonella Infection in a Hospital Study: Accounting for Berkson's Bias.
Ralf Krumkamp, Benno Kreuels, Nimako Sarpong...
https://pubmed.ncbi.nlm.nih.gov/26933027