Clinical trials: in Mali
Uncomplicated Plasmodium Falciparum Malaria
Efficacy, Safety and Tolerability of KLU156 in Adults and Children With Uncomplicated P. Falciparum Malaria
This study aimed to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for…
- Trial name
- KALUMA (NCT05842954)
- Testing
- KLU156, Coartem
- Where
- 32 sites in Burkina Faso, Côte d’Ivoire and 10 more
- Volunteers
- 1,720 people
- Sponsor
- Novartis Pharmaceuticals
Malaria
L9LS MAb in Malian Infants
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of L9LS in infants in Mali and to evaluate the impact of L9LS on subsequent R21/Matrix-MTM vaccine immunogenicity.
- Trial name
- NCT06461026
- Testing
- L9LS, R21/Matrix-MTM
- Where
- 3 sites in Mali
- Volunteers
- 327 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Uncomplicated Plasmodium Falciparum Malaria
Efficacy, Safety and Tolerability of KAF156 in Combination With Lumefantrine Solid Dispersion Formulation (LUM-SDF) in Pediatric Population With Uncomplicated Plasmodium Falciparum Malaria
This study aimed to determine the efficacy, safety and tolerability of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in pediatric patients (6 months to < 18 years of…
- Trial name
- KALUMI (NCT04546633)
- Testing
- KAF156, LUM-SDF, Coartem
- Where
- 9 sites in Burkina Faso, Côte d’Ivoire and 3 more
- Volunteers
- 295 people
- Sponsor
- Novartis Pharmaceuticals
Meningitis
Meningococcal Serogroup ACYWX Conjugate Vaccine in Comparison With MenACWY-TT Conjugate Vaccine
Infants aged 9 months will be randomized to receive a meningococcal vaccine at 9 months or 15 months. Infants randomized to the 9-month age group will be further randomized in a 2:1 ratio to receive a single dose of the…
- Trial name
- NCT05093829
- Testing
- NmCV-5, MenACWY-TT
- Where
- Mali
- Volunteers
- 1,325 people, healthy volunteers welcome
- Sponsor
- Emory University
Plasmodium Falciparum Infection, Malaria
Anti-malaria MAb in Malian Children
The purpose of this study is to evaluate the safety and tolerability of onetime subcutaneous (SC) or intravenous (IV) administration of monoclonal antibody (MAb) L9LS in healthy Malian adults and one-time SC administration of…
- Trial name
- L9LS (NCT05304611)
- Testing
- L9LS (VRC-MALMAB0114-00-AB) Subcutaneous injection, L9LS (VRC-MALMAB0114-00-AB) intravenous injection
- Where
- 2 sites in Mali
- Volunteers
- 365 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Meningitis, Meningococcal
Clinical Study of Meningococcal ACYWX Conjugate Vaccine, in 12-16 Month Olds
Out of the 13 identified serogroups of Neisseria meningitidis (Nm) the six serogroups (A, B, C, W, Y and X) are responsible for majority of infections.
- Trial name
- NCT03295318
- Testing
- Non-adjuvanted study formulation NmCV-5, Adjuvanted study formulation NmCV-5, Menactra
- Where
- Mali
- Volunteers
- 375 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Malaria
Pfs230D1M-EPA/AS01 Vaccine, a Transmission Blocking Vaccine Against Plasmodium Falciparum, in an Age De-Escalation Trial of Children and a Family Compound Trial in Mali
Background: Malaria affects many people in Mali and other parts of Africa. It is spread by mosquito bites. Malaria can make people sick or can lead to death.
- Trial name
- NCT03917654
- Testing
- Pfs230D1M-EPA/AS01, HAVRIX, TYPHIM Vi (Salmonella typhi vaccine)
- Where
- Mali
- Volunteers
- 1,301 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Malaria,Falciparum, Child, Only
Seasonal Malaria Vaccination (RTS,S/AS01) and Seasonal Malaria Chemoprevention (SP/AQ) Extension Study
A double-blind, individual randomised trial will be undertaken in children under five years of age living in areas of Burkina Faso or Mali where the transmission of malaria is intense and highly seasonal to determine whether…
- Trial name
- RTSS-SMC (NCT04319380)
- Testing
- Tetanus/diphtheria toxoids, SMC with SP+AQ, RTS,S/AS01
- Where
- 2 sites in Burkina Faso, Mali
- Volunteers
- 5,098 people
- Sponsor
- London School of Hygiene and Tropical Medicine
Ebola Virus Disease
Partnership for Research on Ebola VACcinations
The purpose of this study is to evaluate the safety and immunogenicity of three vaccine strategies that may prevent Ebola virus disease (EVD) events in children and adults.
- Trial name
- PREVAC (NCT02876328)
- Testing
- Ad26.ZEBOV, MVA-BN-Filo, rVSVΔG-ZEBOV-GP
- Where
- 6 sites in Guinea, Liberia and 2 more
- Volunteers
- 4,789 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Malaria
Safety, Immunogenicity, and Protective Efficacy of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Malaria Transmission Season in Healthy African Adult Women of Childbearing Potential in Mali
Background: Malaria is a disease spread by mosquitos. Pregnant women are highly susceptible to malaria. This can lead to poor health outcomes for pregnant women and their babies.
- Trial name
- NCT03989102
- Testing
- PfSPZ Vaccine, Normal Saline
- Where
- Mali
- Volunteers
- 324 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Malaria, Malaria,Falciparum
PfSPZ Vaccine Trial in Malian Children
In this randomized, double-blind, placebo-controlled trial, 268 healthy Malian children aged 6-10 years, residing in Bancoumana and surrounding villages, will be administered three doses of 9.0x10^5 Pf sporozoites (PfSPZ) of…
- Trial name
- NCT04940130
- Testing
- Sanaria® PfSPZ Vaccine, Normal Saline
- Where
- Mali
- Volunteers
- 290 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria,Falciparum, Children, Only
Seasonal Malaria Vaccination (RTS,S/AS01) and Seasonal Malaria Chemoprevention (SP/AQ)
A double-blind, individual randomised trial will be undertaken in 6000 children under the age of five years living in areas of Burkina Faso or Mali where the transmission of malaria is intense and highly seasonal to determine…
- Trial name
- RTSS-SMC (NCT03143218)
- Testing
- RABIPUR®, RTS,S/AS01, SMC with SP+AQ
- Where
- 2 sites in Burkina Faso, Mali
- Volunteers
- 5,920 people
- Sponsor
- London School of Hygiene and Tropical Medicine
Acute Uncomplicated Plasmodium Falciparum Malaria
Efficacy and Safety of KAF156 in Combination With LUM-SDF in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria
This study was designed to determine the most effective and tolerable dose at the shortest dosing regimen of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in…
- Trial name
- NCT03167242
- Testing
- KAF156, Coartem, Lumefantrine Solid Dispersion Formulation
- Where
- 11 sites in Burkina Faso, Gabon and 7 more
- Volunteers
- 524 people
- Sponsor
- Novartis Pharmaceuticals
Malaria
Pyronaridine Artesunate 3:1 Granule Formulation vs. Coartem© Crushed Tablets in P. Falciparum Malaria Pediatric Patients
The primary objective of this Phase III clinical study is to demonstrate the efficacy of the fixed combination of pyronaridine artesunate (PA) granule formulation (60:20 mg; pediatric PYRAMAX®) by showing a PCR-corrected adequate…
- Trial name
- NCT00541385
- Testing
- pyronaridine artesunate, arthemeter lumefantrine
- Where
- 8 sites in Burkina Faso, Côte d’Ivoire and 6 more
- Volunteers
- 535 people
- Sponsor
- Medicines for Malaria Venture
Malaria
Pyronaridine Artesunate (3:1) Versus Coartem® in P Falciparum Malaria Patients
The primary objective of this phase III study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of Coartem® (artemether lumefantrine, AL) in children and adults…
- Trial name
- NCT00422084
- Testing
- Pyronaridine artesunate, Coartem® (artemether lumefantrine)
- Where
- 10 sites in Democratic Republic of the Congo, Ghana and 7 more
- Volunteers
- 1,272 people
- Sponsor
- Medicines for Malaria Venture
Infections, Streptococcal
Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Zilbrix™ Hib and Polio Sabin™
The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of…
- Trial name
- NCT00678301
- Testing
- GSK Biologicals' Synflorix™, GSK Biologicals' Polio Sabin™, GSK Biologicals' Zilbrix™ Hib
- Where
- 2 sites in Mali, Nigeria
- Volunteers
- 365 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diarrhea Rotavirus
Immune Response to Rotavirus Vaccine After a Supplemental Dose Given at 9 Months of Age With Local EPI Vaccines in Mali
This study is an evaluation of the immune response to pentavalent rotavirus vaccine (PRV) after an additional fourth dose is given at 9 months of age with local World Health Organization (WHO) Expanded Programme on Immunization…
- Trial name
- NCT02286895
- Testing
- pentavalent rotavirus vaccine (PRV), measles vaccine (MV), yellow fever vaccine (YFV)
- Where
- Mali
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- PATH
Infections, Streptococcal
Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Mali
The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A when administered either as a booster dose or as a two dose catch-up vaccination…
- Trial name
- NCT00985465
- Testing
- Pneumococcal vaccine GSK1024850A
- Where
- Mali
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Plasmodium Falciparum Malaria
Phase II AMA-1 Malaria Vaccine FMP2.1/AS02A Trial in Mali
Malaria is a disease that affects many people in Africa. Malaria is caused by germs spread by mosquito bites. The purpose of this study is to compare the number of children who get malaria after receiving an experimental malaria…
- Trial name
- NCT00460525
- Testing
- FMP2.1/AS02A, Rabies Vaccine
- Where
- Mali
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Virus Diseases
A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Children
The purpose of this study is to assess the safety and reactogenicity of a single IM dose of the GSK3390107A (ChAd3 EBO-Z) vaccine, overall and in children aged 1 to 5, 6 to 12, and 13 to 17 years, separately.
- Trial name
- NCT02548078
- Testing
- GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A), Nimenrix powder and solvent for solution for injection in pre-filled syringe; Meningococcal group A, C, W-135 and Y conjugate vaccine
- Where
- 2 sites in Mali, Senegal
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline