Clinical trials: Malaria
Malaria
Efficacy, Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Evaluating Different Dose Schedules in a Sporozoite Challenge Model in Healthy Malaria-naïve Adults
This study is designed to evaluate efficacy, immunogenicity and safety of various dose schedules of GSK Biologicals' candidate malaria vaccines RTS,S/AS01B (adult formulation) and RTS,S/AS01E (pediatric formulation) in healthy…
- Trial name
- NCT03162614
- Testing
- RTS,S/AS01E, RTS,S/AS01B, Sporozoite-infected mosquitoes challenge.
- Where
- United States
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Drug-Drug Interaction, HIV Infection
Dihydroartemisinin-Piperaquine in the Context of Antiretroviral Therapy
Open-label prospective intensive pharmacokinetic study of dihydroartemisinin-piperaquine (DP) in HIV-infected children on efavirenz (EFV)-, lopinavir/ritonavir (LPV/r)-, or dolutegravir (DTG)-based antiretroviral therapy (ART)…
- Trial name
- DPART (NCT04487145)
- Testing
- Dihydroartemisinin-piperaquine
- Where
- 2 sites in Uganda
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
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
Fever, Malaria
Innovative Public-private Partnership to Target Subsidized Antimalarials in the Retail Sector (Aim 2)
The overall objective of this study is to evaluate the public health impact of targeted antimalarials subsidies through scale-up by determining the community-wide effects of targeting an antimalarial subsidy through a partnership…
- Trial name
- NCT02461628
- Testing
- Malaria RDT & conditional voucher for ACT from retail sector
- Where
- Kenya
- Volunteers
- 40,340 people, healthy volunteers welcome
- Sponsor
- Duke University
Plasmodium Falciparum Malaria
Phase I Pediatric FMP2.1/AS02A Trial in Mali
The purpose of this study is to test the safety and dosages of a malaria vaccine in 100 children, 1-6 years old, in Bandiagara, Mali.
- Trial name
- NCT00358332
- Testing
- FMP2.1/AS02A, Rabies vaccine (RabAvert)
- Where
- Mali
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Malaria
Healthy Volunteer Study of the Pharmacokinetics of Oral Piperaquine With OZ439 + TPGS Formulation in the Fasted State
Piperaquine tablets (coated) + OZ439 granules + TPGS granules will be co-administered in Phase IIb (adults). However, safety and PK data (for OZ439 plus piperaquine) were obtained using piperaquine tablets plus OZ439 as Powder in…
- Trial name
- NCT01853475
- Testing
- PQP tablets 960mg, PQP tablets 1440mg, OZ439+TPGS 800mg
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
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
Malaria
Trial to Evaluate L9LS in Healthy Adults
Background: Malaria is a parasitic disease carried by mosquitoes in tropical areas. There is no vaccine to prevent malaria infection. If not treated right away, it can become serious or deadly.
- Trial name
- VRC 614 (NCT05019729)
- Testing
- VRC-MALMAB0114-00-AB, Plasmodium falciparum (P. falciparum) sporozoite challenge
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Malaria
Consistency of Immunogenicity and Non Inferiority of GSK Biologicals' Candidate Malaria Vaccine Lots in Children
The purpose of this study is to show the consistency of different lots of a candidate vaccine (257049) against malaria developed by GlaxoSmithKline (GSK) Biologicals.
- Trial name
- NCT01323972
- Testing
- GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)
- Where
- 2 sites in Nigeria
- Volunteers
- 327 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
A Study to Evaluate the Efficacy, Immunogenicity and Safety in a Sporozoite Challenge Model of a Fractional Booster Dose of GSK Biologicals' Candidate Malaria Vaccine Administered to Previously Vaccinated Healthy Malaria-naïve Adults
MALARIA-092 (NCT03162614) study was designed to evaluate the efficacy, immunogenicity and safety of various dose schedules and formulations of GSK Biologicals' candidate malaria vaccine (RTS,S/AS01E) in healthy malaria-naïve…
- Trial name
- NCT03824236
- Testing
- RTS,S/AS01E (SB257049)
- Where
- United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria, Vivax
Safety, Immunogenicity and Efficacy of the Blood-stage Plasmodium Vivax Malaria Vaccine Candidate PvDBPII in Matrix M1
This is an Open label, first-in-human, Phase I/IIa, blood-stage P. vivax malaria vaccine trial to assess the safety, immunogenicity and efficacy of the blood-stage Plasmodium vivax malaria vaccine candidate PvDBPII in Matrix M1…
- Trial name
- NCT04201431
- Testing
- PvDBPII/Matrix-M1
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Malaria, Vivax
A Pharmacokinetics, Safety and Efficacy Study of Tafenoquine (TQ) in Pediatric Subjects With Plasmodium Vivax (P. Vivax) Malaria
This is a prospective, open-label, multicenter, non-comparative, single arm study of pediatric subjects with Plasmodium vivax (P. vivax) malaria, aged 6 months to <16 years of age. A total of 60 subjects will be enrolled.
- Trial name
- NCT02563496
- Testing
- Tafenoquine, Chloroquine
- Where
- 4 sites in Colombia, Vietnam
- Volunteers
- 60 people
- Sponsor
- GlaxoSmithKline
Malaria, Malaria,Falciparum
Safety and Efficacy of R0.6C Vaccine
This is a first-in-human phase I, open-label, single-site, dose escalation study to determine the safety, tolerability and Plasmodium falciparum transmission reducing activity of the R0.6C vaccine in two different adjuvant…
- Trial name
- STOP-TRANS (NCT04862416)
- Testing
- R0.6C transmission blocking vaccine
- Where
- Netherlands
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Malaria
Reducing the Burden of Malaria in HIV-uninfected Pregnant Women and Infants
This will be a double-blinded randomized controlled phase III trial of 300 HIV uninfected pregnant women and the children born to them. The study interventions will be divided into two phases.
- Trial name
- PROMOTE-BC1 (NCT02163447)
- Testing
- Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy, 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy, 3 dose sulfadoxine-pyrimethamine (SP) for adult women during pregnancy
- Where
- Uganda
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Grant Dorsey, M.D, Ph.D.
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
Uncomplicated Plasmodium Falciparum Malaria
Extended Duration Artemether-lumefantrine Treatment for Malaria in Children
This project determines the pharmacokinetic/pharmacodynamic (PK/PD) of an extended artemether-lumefantrine (AL) dosing regimen in HIV-infected children on efavirenz (EFV)-based antiretroviral therapy (ART) that is designed to…
- Trial name
- EXALT (NCT03453840)
- Testing
- Artemether-lumefantrine
- Where
- 2 sites in Uganda
- Volunteers
- 305 people
- Sponsor
- University of California, San Francisco
Malaria, Falciparum
Double-blind, Randomized, Controlled Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine
This trial is currently evaluating one candidate malaria vaccine, FMP1/AS02A. This candidate malaria vaccine is being developed for the routine immunization of infants and children living in malaria-endemic areas.
- Trial name
- NCT00223990
- Testing
- FMP1/AS02A, RabAvert
- Where
- Kenya
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Malaria
Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults
This study is a Phase 1, dose escalation, first-in-human study designed primarily to evaluate the safety of the purified plant-derived Pfs25 VLP combined with Alhydrogel adjuvant
- Trial name
- NCT02013687
- Testing
- Pfs25 VLP- FhCMB
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Fraunhofer, Center for Molecular Biotechnology
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
Effectiveness of OZ439 as a Gametocytocidal and Transmission Blocking Agent
This is a single-centre, controlled, open label study using P. falciparum-induced blood stage malaria (IBSM) infection to assess the effectiveness of OZ439 as a gametocytocidal agent, as well as its treatment effects on…
- Trial name
- OZGAM (NCT02431650)
- Testing
- OZ439, Primaquine
- Where
- Australia
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture