Invasive Non-Typhoidal Salmonella DiseaseVINSNCT07416461
Effectiveness of Malaria Vaccines in Reducing the Risk of Invasive Non-typhoidal Salmonella Disease
An observational study of Invasive Non-Typhoidal Salmonella Disease and Malaria, run by International Vaccine Institute at 1 site in Democratic Republic of the Congo.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Invasive Non-Typhoidal Salmonella Disease, Malaria, Malaria Vaccine
- What is being tested?
- R21/Matrix-M malaria vaccine
- Type of treatment
- Vaccines
- How many people
- 10,000 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 27 Oct 2025to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Democratic Republic of the Congo1 site, 1 recruiting
- Recruiting
Institut National de Recherche Biomedicale (INRB)
Kinshasa
Octavie Lunguya, PHD, +243815181121, octmetila@yahoo.fr
About this study
Official title: Effectiveness of Malaria Vaccines in Reducing the Risk of Invasive Non-Typhoidal Salmonella Disease (VINS)
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.
Read the detailed description
- 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.
- Being tested
- R21/Matrix-M malaria vaccine
- Keywords
- Malaria, Vaccine effectiveness, iNTS, Invasive Non-Typhoidal Salmonella Disease, DRC, Democratic Republic of Congo, Malaria vaccine, Effectiveness, R21/Matrix-M
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R21/Matrix-M malaria vaccineBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Age-eligible children who received the R21/Matrix-M Malaria Vaccine. | Depending on the study objective, participants who received at least the three primary doses of the R21/Matrix-M vaccine will be considered for analysis (complete vaccination - primary objective) or participants who received either the first or first two doses of R21/Matrix-M vaccine (incomplete vaccination - secondary objectives) shall be considered for analysis. Receives: Biological: R21/Matrix-M malaria vaccine | |
| Age-eligible children who were not vaccinated against malaria. | Unvaccinated participants will be defined as not meeting the definitions for complete nor incomplete vaccination by time of enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At presentation (enrollment)
Secondary outcomes (5)
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.
Measured: At presentation (enrollment)
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.
Measured: At presentation (enrollment)
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.
Measured: At presentation (enrollment)
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.
Measured: At presentation (enrollment)
Impact of vaccination using R21/Matrix-M on the incidence of culture-confirmed iNTS and mRDT, blood smear and/or PCR confirmed malaria co-infection (before/after)
Among individuals seeking care for symptoms consistent with clinical malaria/iNTS (age-cohorts exposed to R21/Matrix-M vaccination program), relative rate of healthcare-ascertained, laboratory-confirmed malaria-iNTS co-infections 1-year-after versus before the introduction of the program will be 1.00 - 0.38 or lower.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start27 Oct 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Invasive Non-Typhoidal Salmonella DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Vaccine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Octavie Lunguya, Principal investigator, Institut National de Recherche Biomedicale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416461
- Sponsor's protocol ID
- 2025-002
- Acronym
- VINS
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
von Kalckreuth V, Konings F, Aaby P, Adu-Sarkodie Y, Ali M, Aseffa A, Baker S, Breiman RF, Bjerregaard-Andersen M, Clemens JD, Crump JA, Cruz Espinoza LM, Deerin JF, Gasmelseed N, Sow AG, Im J, Keddy KH, Cosmas L, May J, Meyer CG, Mintz ED, Montgomery JM, Olack B, Pak GD, Panzner U, Park SE, Rakotozandrindrainy R, Schutt-Gerowitt H, Soura AB, Warren MR, Wierzba TF, Marks F. The Typhoid Fever Surveillance in Africa Program (TSAP): Clinical, Diagnostic, and Epidemiological Methodologies. Clin Infect Dis. 2016 Mar 15;62 Suppl 1(Suppl 1):S9-S16. doi: 10.1093/cid/civ693.
PubMed 26933028Liang Y, Driscoll AJ, Patel PD, Datta S, Voysey M, French N, Jamka LP, Henrion MYR, Ndeketa L, Laurens MB, Heyderman RS, Gordon MA, Neuzil KM. Typhoid conjugate vaccine effectiveness in Malawi: evaluation of a test-negative design using randomised, controlled clinical trial data. Lancet Glob Health. 2023 Jan;11(1):e136-e144. doi: 10.1016/S2214-109X(22)00466-1. Epub 2022 Nov 25.
PubMed 36442498Bornstein K, Hungerford L, Hartley D, Sorkin JD, Tapia MD, Sow SO, Onwuchekwa U, Simon R, Tennant SM, Levine MM. Modeling the Potential for Vaccination to Diminish the Burden of Invasive Non-typhoidal Salmonella Disease in Young Children in Mali, West Africa. PLoS Negl Trop Dis. 2017 Feb 9;11(2):e0005283. doi: 10.1371/journal.pntd.0005283. eCollection 2017 Feb.
PubMed 28182657Datoo MS, Dicko A, Tinto H, Ouedraogo JB, Hamaluba M, Olotu A, Beaumont E, Ramos Lopez F, Natama HM, Weston S, Chemba M, Compaore YD, Issiaka D, Salou D, Some AM, Omenda S, Lawrie A, Bejon P, Rao H, Chandramohan D, Roberts R, Bharati S, Stockdale L, Gairola S, Greenwood BM, Ewer KJ, Bradley J, Kulkarni PS, Shaligram U, Hill AVS; R21/Matrix-M Phase 3 Trial Group. Safety and efficacy of malaria vaccine candidate R21/Matrix-M in African children: a multicentre, double-blind, randomised, phase 3 trial. Lancet. 2024 Feb 10;403(10426):533-544. doi: 10.1016/S0140-6736(23)02511-4. Epub 2024 Feb 1.
PubMed 38310910Nyirenda TS, Mandala WL, Gordon MA, Mastroeni P. Immunological bases of increased susceptibility to invasive nontyphoidal Salmonella infection in children with malaria and anaemia. Microbes Infect. 2018 Oct-Nov;20(9-10):589-598. doi: 10.1016/j.micinf.2017.11.014. Epub 2017 Dec 15.
PubMed 29248635van Santen S, de Mast Q, Swinkels DW, van der Ven AJ. The iron link between malaria and invasive non-typhoid Salmonella infections. Trends Parasitol. 2013 May;29(5):220-7. doi: 10.1016/j.pt.2013.03.006. Epub 2013 Apr 16.
PubMed 23601932Church J, Maitland K. Invasive bacterial co-infection in African children with Plasmodium falciparum malaria: a systematic review. BMC Med. 2014 Feb 19;12:31. doi: 10.1186/1741-7015-12-31.
PubMed 24548672Crump JA, Sjolund-Karlsson M, Gordon MA, Parry CM. Epidemiology, Clinical Presentation, Laboratory Diagnosis, Antimicrobial Resistance, and Antimicrobial Management of Invasive Salmonella Infections. Clin Microbiol Rev. 2015 Oct;28(4):901-37. doi: 10.1128/CMR.00002-15.
PubMed 26180063Park SE, Pak GD, Aaby P, Adu-Sarkodie Y, Ali M, Aseffa A, Biggs HM, Bjerregaard-Andersen M, Breiman RF, Crump JA, Cruz Espinoza LM, Eltayeb MA, Gasmelseed N, Hertz JT, Im J, Jaeger A, Parfait Kabore L, von Kalckreuth V, Keddy KH, Konings F, Krumkamp R, MacLennan CA, Meyer CG, Montgomery JM, Ahmet Niang A, Nichols C, Olack B, Panzner U, Park JK, Rabezanahary H, Rakotozandrindrainy R, Sampo E, Sarpong N, Schutt-Gerowitt H, Sooka A, Soura AB, Sow AG, Tall A, Teferi M, Yeshitela B, May J, Wierzba TF, Clemens JD, Baker S, Marks F. The Relationship Between Invasive Nontyphoidal Salmonella Disease, Other Bacterial Bloodstream Infections, and Malaria in Sub-Saharan Africa. Clin Infect Dis. 2016 Mar 15;62 Suppl 1(Suppl 1):S23-31. doi: 10.1093/cid/civ893.
PubMed 26933016Krumkamp R, Kreuels B, Sarpong N, Boahen KG, Foli G, Hogan B, Jaeger A, Reigl L, Zeeb H, Marks F, Adu-Sarkodie Y, May J. Association Between Malaria and Invasive Nontyphoidal Salmonella Infection in a Hospital Study: Accounting for Berkson's Bias. Clin Infect Dis. 2016 Mar 15;62 Suppl 1:S83-9. doi: 10.1093/cid/civ950.
PubMed 26933027Kim JH, Tack B, Fiorino F, Pettini E, Marchello CS, Jacobs J, Crump JA, Marks F; Vacc-iNTS Consortium. Examining geospatial and temporal distribution of invasive non-typhoidal Salmonella disease occurrence in sub-Saharan Africa: a systematic review and modelling study. BMJ Open. 2024 Mar 14;14(3):e080501. doi: 10.1136/bmjopen-2023-080501.
PubMed 38485477
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Malaria Vaccines in Reducing the Risk of Invasive Non-Typhoidal Salmonella Disease (VINS)
- ClinicalTrials.gov ID
- NCT07416461
- Acronym / sponsor ID
- VINS / 2025-002
- Keywords
- Malaria, Vaccine effectiveness, iNTS, Invasive Non-Typhoidal Salmonella Disease, DRC, Democratic Republic of Congo, Malaria vaccine, Effectiveness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- International Vaccine InstituteUniversity, hospital or other
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Age-eligible children who received the R21/Matrix-M Malaria Vaccine. | – | Biological: R21/Matrix-M malaria vaccineDepending on the study objective, participants who received at least the three primary doses of the R21/Matrix-M vaccine will be considered for analysis (complete vaccination - primary objective) or participants who received either the first or first two doses of R21/Matrix-M vaccine (incomplete vaccination - secondary objectives) shall be considered for analysis. |
| Age-eligible children who were not vaccinated against malaria. | – | –Unvaccinated participants will be defined as not meeting the definitions for complete nor incomplete vaccination by time of enrollment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R21/Matrix-M malaria 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. | Biological | Age-eligible children who received the R21/Matrix-M Malaria Vaccine. |
Primary outcome
Blood culture-confirmed iNTS disease (including malaria co-infections) in participants who received complete malaria vaccination vs. unvaccinated participants.
Time frame: At presentation (enrollment)
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.
5 secondary outcomes
Blood culture-confirmed iNTS disease (including malaria co-infections) in participants who received any dose of malaria vaccine vs. unvaccinated participants.
Time frame: At presentation (enrollment)
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.
Time frame: At presentation (enrollment)
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.
Time frame: At presentation (enrollment)
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
Time frame: At presentation (enrollment)
Impact of vaccination using R21/Matrix-M on the incidence of culture-confirmed iNTS and mRDT, blood smear and/or PCR confirmed malaria co-infection (before/after)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Background: PubMed 26933028von Kalckreuth V, Konings F, Aaby P, Adu-Sarkodie Y, Ali M, Aseffa A, Baker S, Breiman RF, Bjerregaard-Andersen M, Clemens JD, Crump JA, Cruz Espinoza LM, Deerin JF, Gasmelseed N, Sow AG, Im J, Keddy KH, Cosmas L, May J, Meyer CG, Mintz ED, Montgomery JM, Olack B, Pak GD, Panzner U, Park SE, Rakotozandrindrainy R, Schutt-Gerowitt H, Soura AB, Warren MR, Wierzba TF, Marks F. The Typhoid Fever Surveillance in Africa Program (TSAP): Clinical, Diagnostic, and Epidemiological Methodologies. Clin Infect Dis. 2016 Mar 15;62 Suppl 1(Suppl 1):S9-S16. doi: 10.1093/cid/civ693.
- Background: PubMed 36442498Liang Y, Driscoll AJ, Patel PD, Datta S, Voysey M, French N, Jamka LP, Henrion MYR, Ndeketa L, Laurens MB, Heyderman RS, Gordon MA, Neuzil KM. Typhoid conjugate vaccine effectiveness in Malawi: evaluation of a test-negative design using randomised, controlled clinical trial data. Lancet Glob Health. 2023 Jan;11(1):e136-e144. doi: 10.1016/S2214-109X(22)00466-1. Epub 2022 Nov 25.
- Background: PubMed 28182657Bornstein K, Hungerford L, Hartley D, Sorkin JD, Tapia MD, Sow SO, Onwuchekwa U, Simon R, Tennant SM, Levine MM. Modeling the Potential for Vaccination to Diminish the Burden of Invasive Non-typhoidal Salmonella Disease in Young Children in Mali, West Africa. PLoS Negl Trop Dis. 2017 Feb 9;11(2):e0005283. doi: 10.1371/journal.pntd.0005283. eCollection 2017 Feb.
- Background: PubMed 38310910Datoo MS, Dicko A, Tinto H, Ouedraogo JB, Hamaluba M, Olotu A, Beaumont E, Ramos Lopez F, Natama HM, Weston S, Chemba M, Compaore YD, Issiaka D, Salou D, Some AM, Omenda S, Lawrie A, Bejon P, Rao H, Chandramohan D, Roberts R, Bharati S, Stockdale L, Gairola S, Greenwood BM, Ewer KJ, Bradley J, Kulkarni PS, Shaligram U, Hill AVS; R21/Matrix-M Phase 3 Trial Group. Safety and efficacy of malaria vaccine candidate R21/Matrix-M in African children: a multicentre, double-blind, randomised, phase 3 trial. Lancet. 2024 Feb 10;403(10426):533-544. doi: 10.1016/S0140-6736(23)02511-4. Epub 2024 Feb 1.
- Background: PubMed 29248635Nyirenda TS, Mandala WL, Gordon MA, Mastroeni P. Immunological bases of increased susceptibility to invasive nontyphoidal Salmonella infection in children with malaria and anaemia. Microbes Infect. 2018 Oct-Nov;20(9-10):589-598. doi: 10.1016/j.micinf.2017.11.014. Epub 2017 Dec 15.
- Background: PubMed 23601932van Santen S, de Mast Q, Swinkels DW, van der Ven AJ. The iron link between malaria and invasive non-typhoid Salmonella infections. Trends Parasitol. 2013 May;29(5):220-7. doi: 10.1016/j.pt.2013.03.006. Epub 2013 Apr 16.
- Background: PubMed 24548672Church J, Maitland K. Invasive bacterial co-infection in African children with Plasmodium falciparum malaria: a systematic review. BMC Med. 2014 Feb 19;12:31. doi: 10.1186/1741-7015-12-31.
- Background: PubMed 26180063Crump JA, Sjolund-Karlsson M, Gordon MA, Parry CM. Epidemiology, Clinical Presentation, Laboratory Diagnosis, Antimicrobial Resistance, and Antimicrobial Management of Invasive Salmonella Infections. Clin Microbiol Rev. 2015 Oct;28(4):901-37. doi: 10.1128/CMR.00002-15.
- Background: PubMed 26933016Park SE, Pak GD, Aaby P, Adu-Sarkodie Y, Ali M, Aseffa A, Biggs HM, Bjerregaard-Andersen M, Breiman RF, Crump JA, Cruz Espinoza LM, Eltayeb MA, Gasmelseed N, Hertz JT, Im J, Jaeger A, Parfait Kabore L, von Kalckreuth V, Keddy KH, Konings F, Krumkamp R, MacLennan CA, Meyer CG, Montgomery JM, Ahmet Niang A, Nichols C, Olack B, Panzner U, Park JK, Rabezanahary H, Rakotozandrindrainy R, Sampo E, Sarpong N, Schutt-Gerowitt H, Sooka A, Soura AB, Sow AG, Tall A, Teferi M, Yeshitela B, May J, Wierzba TF, Clemens JD, Baker S, Marks F. The Relationship Between Invasive Nontyphoidal Salmonella Disease, Other Bacterial Bloodstream Infections, and Malaria in Sub-Saharan Africa. Clin Infect Dis. 2016 Mar 15;62 Suppl 1(Suppl 1):S23-31. doi: 10.1093/cid/civ893.
- Background: PubMed 26933027Krumkamp R, Kreuels B, Sarpong N, Boahen KG, Foli G, Hogan B, Jaeger A, Reigl L, Zeeb H, Marks F, Adu-Sarkodie Y, May J. Association Between Malaria and Invasive Nontyphoidal Salmonella Infection in a Hospital Study: Accounting for Berkson's Bias. Clin Infect Dis. 2016 Mar 15;62 Suppl 1:S83-9. doi: 10.1093/cid/civ950.
- Background: PubMed 38485477Kim JH, Tack B, Fiorino F, Pettini E, Marchello CS, Jacobs J, Crump JA, Marks F; Vacc-iNTS Consortium. Examining geospatial and temporal distribution of invasive non-typhoidal Salmonella disease occurrence in sub-Saharan Africa: a systematic review and modelling study. BMJ Open. 2024 Mar 14;14(3):e080501. doi: 10.1136/bmjopen-2023-080501.
- Individual participant dataSharing planned: Undecided
Related trials for Invasive Non-Typhoidal Salmonella Disease
Active, not recruiting
Challenge Non-Typhoidal Salmonella (CHANTS) Study
Salmonella Infections, Salmonella Typhimurium
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Octavie Lunguya principal investigator
Institut National de Recherche Biomedicale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Non-Typhoidal Salmonella Disease and Malaria, run by International Vaccine Institute at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Birkneh Tadesse, MD, PHD (+821098041348, Birkneh.Tadesse@ivi.int), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood culture-confirmed iNTS disease (including malaria co-infections) in participants who received complete malaria vaccination vs. unvaccinated participants. (time frame: At presentation (enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07416461, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.