Clinical trials: malaria
Healthy Volunteers
Malaria: Relative Bioavailability and Food Effect of DSM265
Phase 1 study designed to evaluate the relative bioavailability of a single dose of a test formulation, DSM265-TPGS 34% SDD powder in comparison with a reference DSM265 25% SDD powder formulation used in early clinical trials.
- Trial name
- NCT03637517
- Testing
- DSM265-TPGS 34% SDD, 400 mg fasted, DSM265-TPGS 34% SDD, 400 mg fed, DSM265 25% SDD, 400 mg fasted
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Malaria, Malaria Vaccines
Study to Evaluate Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)
This study has been designed to support the indication of the candidate vaccine (also referred to as GSK 257049 or RTS,S in this record) against hepatitis B virus infection, when administered as a primary vaccination integrated…
- Trial name
- NCT01345240
- Testing
- GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049, Engerix-B™ vaccine, Infanrix/Hib™ vaccine
- Where
- 2 sites in Burkina Faso, Ghana
- Volunteers
- 705 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cure Rate
A Study to Assess Efficacy, Safety of KAE609 in Adult Patients With Acute Malaria Mono-infection
This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with acute P. falciparum infection after single dose with KAE609 at 75 mg, 150mg, 225mg and 300mg/day
- Trial name
- NCT01860989
- Testing
- KAE609
- Where
- 4 sites in Thailand, Vietnam
- Volunteers
- 11 people
- Sponsor
- Novartis Pharmaceuticals
Seizure, Epilepsy
Enteral Levetiracetam For Seizure Control In Pediatric Cerebral Malaria
Pediatric cerebral malaria (CM) affects more than 3 million children each year killing ~20% and leaving one third of survivors with long term neurologic and psychiatric sequelae.
- Conditions
- Seizure, Epilepsy, Cerebral Malaria
- Trial name
- LVT1 (NCT01660672)
- Testing
- LEVETIRACETAM
- Where
- Malawi
- Volunteers
- 7 people
- Sponsor
- University of Rochester
Malaria
Trial of a Falciparum Malaria Protein (FMP012), E. Coli-expressed PfCelTOS, in Healthy Malaria-Naive Adults
Malaria has remained a major concern for the US military. During World War II, malaria was the leading cause of disease and non-battle injury with 500-700 men infected per day, resulting in 24,000 malaria-related casualties.(10)…
- Trial name
- NCT01540474
- Testing
- Group 1: 10 ug FMP012 with 2 ug GLA-SE, Group 2: 10 ug FMP012 with 5 ug GLA-SE, 50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Plasmodium Falciparum Infection, Malaria
Anti-malaria MAb in Kenyan Children
The purpose of this study is to evaluate the safety and tolerability of one-time subcutaneous (SC) administration of monoclonal antibody (MAb) L9LS in healthy Kenyan children aged 5 months to 10 years, as well as the protective…
- Trial name
- NCT05400655
- Testing
- L9LS
- Where
- Kenya
- Volunteers
- 912 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Acute Uncomplicated Falciparum Malaria
Efficacy, Safety and Pharmacokinetics of Artemether-lumefantrine Dispersible Tablet in the Treatment of Malaria in Infants < 5 kg
The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data following treatment with artemether-lumefantrine dispersible tablet in infants < 5 kg of body weight (BW) with uncomplicated falciparum malaria.
- Trial name
- NCT01619878
- Testing
- Artemether-lumefantrine (COA566)
- Where
- 7 sites in Benin, Burkina Faso and 3 more
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
Covid19, Paludism
Malaria as a Protection Factor Against Severe COVID-19 (Known as SARS-COV-2) in the Democratic Republic of Congo (Palu-COVID)
In this study, the investigators will explore the reasons for the apparently lower proportion of severe COVID-19 cases in many sub-Sahara African countries.
- Trial name
- Palu-COVID (NCT05012280)
- Where
- Democratic Republic of the Congo
- Volunteers
- 238 people
- Sponsor
- Institute of Tropical Medicine, Belgium
Malaria
MMV390048 POC in Patients With P. Vivax and P. Falciparum Malaria
The present proof-of-concept Phase IIa study aims to confirm, in patients, the observed activity of MMV390048 against P. falciparum in pre-clinical models and the human Induced Blood-Stage Malaria (IBSM) challenge model, and to…
- Trial name
- NCT02880241
- Testing
- MMV390048
- Where
- 2 sites in Ethiopia
- Volunteers
- 8 people
- Sponsor
- Medicines for Malaria Venture
Malaria
Safety, Tolerability and Antimalarial Activity of Single Doses of OZ439 and PQP
A single-centre Phase 1b study to assess the safety, tolerability, pharmacokinetic profile, and antimalarial activity of single doses of coadministered artefenomel (OZ439) and piperaquine phosphate (PQP) against early Plasmodium…
- Trial name
- NCT03542149
- Testing
- 480 mg Piperaquine phosphate, 640 mg Piperaquine phosphate, 200 mg OZ 439
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Malaria,Falciparum
Evaluate the Infectivity Equivalence of Current and New Lots of Plasmodium Falciparum Strain NF54
Objectives: Primary: To characterize the infectivity of the new lot of Plasmodium falciparum strain 3D7 within the standard WRAIR CHMI model as compared to the current lot (historical data) Secondary: To assess safety of the new…
- Trial name
- NCT03882528
- Testing
- Plasmodium falciparum malaria parasite
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Malaria, Falciparum
MMV390048 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Participants
A single-centre, open-label, study using induced blood stage malaria infection to characterize the activity of MMV390048 against early Plasmodium falciparum blood stage infection.
- Trial name
- NCT02281344
- Testing
- MMV390048 20mg
- Where
- Australia
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Malaria
Absolute BA and OZ439 PK Effect of Different OZ439 Dose Volumes and Cobicistat Co-administration Study
This study is an open-label, two-part study to determine the absolute bioavailability (BA) of OZ439 using simultaneous intravenous [14C]-OZ439 microdose/800mg oral dosing and to investigate the pharmacokinetics (PK) of OZ439…
- Trial name
- NCT04069221
- Testing
- Single oral dose of 800 mg OZ439, Single oral dose of 400 mg OZ439, Single oral dose of cobicistat
- Where
- Netherlands
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Malaria, Malaria Vaccines
Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Given at 6, 7.5 and 9 Months of Age in Co-administration With Measles, Rubella and Yellow Fever (YF) Vaccines Followed by a Booster of the Malaria Vaccine.
The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of the SB257049 candidate malaria vaccine when co-administered with Vitamin A, measles, rubella and yellow fever vaccines to children aged 6…
- Trial name
- NCT02699099
- Testing
- Vitamin A, Candidate Plasmodium falciparum malaria vaccine, MR-Vac
- Where
- 2 sites in Ghana
- Volunteers
- 699 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria, Malaria Vaccines
Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
This epidemiology study was conducted in parallel with the EPI-MAL-002 (NCT02374450) and EPI-MAL-003 (NCT03855995) studies, enrolling participants from the same health and demographic surveillance system (HDSS) (or equivalent…
- Trial name
- NCT02251704
- Testing
- Assessment of body temperature, Blood sampling
- Where
- 12 sites in Burkina Faso, Ghana and 4 more
- Volunteers
- 54,115 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Plasmodium Falciparum Infection
Chloroquine Alone or in Combination for Malaria in Children in Malawi
Malaria is a sickness caused by a germ that can get into a person's body when a mosquito bites them. It can cause fever, headache, body aches and weakness. It can even cause death, especially in children.
- Trial name
- NCT00379821
- Testing
- Atovaquone-proguanil, Artesunate, Azithromycin
- Where
- Malawi
- Volunteers
- 640 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Plasmodium Falciparum Malaria
Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of America
Phase I/II Trial of a Malaria Vaccine, FMP011/AS01B, in Adults Living in the United States of America.
- Trial name
- NCT00312663
- Testing
- Falciparum Malaria Protein 11 with AS01B adjuvant.
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Malaria
Safety, Tolerability and Chemoprotective Activity of P218 in PfSPZ Challenge Model
This was a single centre, randomised, double-blind, placebo-controlled Phase Ib study, to evaluate the safety, tolerability and chemoprotective activity of P218 in a controlled P. falciparum sporozoite infection model.
- Trial name
- NCT03707041
- Testing
- P218 (1000 mg) Oral Capsules, P218 (100 mg) Oral Capsules, PfSPZ Challenge
- Where
- Belgium
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Malaria
A Study to Characterise the Antimalarial and Transmission Blocking Activity of a Single Dose of DSM265 or OZ439 in Healthy Subjects With Induced Blood Stage Plasmodium Falciparum or Plasmodium Vivax Infection
Part A -Cohort 1 DSM265 will be administered as a single dose (400 mg). For cohort 1 only, an additional single dose (400 mg) of DSM265 may be given if gametocytemia develops.
- Trial name
- DSMOZ-2 (NCT02573857)
- Testing
- DSM265, OZ439
- Where
- Australia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Plasmodium Falciparum Malaria
Phase II Dose-ranging Study of Pyronaridine/Artesunate in Adults Patients With Plasmodium Falciparum Malaria
The primary trial objective is to determine the clinically effective dose of orally administered pyronaridine/artesunate (Pyramax®, PA) with a 3:1 ratio to treat adults with acute, symptomatic, uncomplicated P.
- Trial name
- NCT01594931
- Testing
- pyronaridine/artesunate
- Where
- 6 sites in Cambodia, Indonesia and 4 more
- Volunteers
- 477 people
- Sponsor
- Medicines for Malaria Venture