Clinical trials: Malaria Falciparum
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
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
Healthy
First-in-Human Trial of Single Ascending Dose, Multiple Ascending Dose and Malaria Challenge Model in Healthy Participants
The primary purpose of this study was to investigate the safety and tolerability of M5717 and to characterize the Pharmacokinetics (PK) /Pharmacodynamic relationship between M5717 PK and parasite clearance in healthy participants…
- Trial name
- NCT03261401
- Testing
- M5717
- Where
- Australia
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Plasmodium Falciparum
Safety, Immunogenicity of RTS,S/AS02A, and RTS,S/AS01B Malaria Vaccines in Malaria-experienced Adults.
The candidate malaria vaccine RTS,S/AS02A developed by GSK Biologicals demonstrated 30% efficacy against clinical episodes of malaria and approximately 58% efficacy against severe malaria disease.
- Trial name
- NCT00197054
- Testing
- RTS, S/AS01B, RTS, S/AS02A, Rabipur (Rabies) Vaccine
- Where
- Kenya
- Volunteers
- 255 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
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
Malaria
Clinical Investigation Study to Evaluate the Consistency and Reproducibility of Two Consecutive Mosquito Feeding Assays
The proposed trial design has been developed to assess the consistency and reproducibility of two consecutive direct skin feeding assays (DSFA) at 24-hour interval.
- Trial name
- NCT04666350
- Testing
- Direct Skin Feeding Assay (DSFA), Primaquine, Artemether/Lumefantrine
- Where
- Kenya
- Volunteers
- 42 people
- Sponsor
- PATH
Malaria, Falciparum, Malaria, Vivax
Efficacy of SJ733 in Adults With Uncomplicated Plasmodium Falciparum or Vivax Malaria
This Phase 2a trial recruits adult patients with uncomplicated P. vivax or P. falciparum blood-stage malaria mono-infection. The study drug SJ733 will be administered to examine its antimalarial efficacy, safety, and…
- Trial name
- NCT04709692
- Testing
- (+)-SJ000557733 (SJ733)
- Where
- Peru
- Volunteers
- 22 people
- Sponsor
- R. Kiplin Guy
Malaria, Plasmodium Falciparum
Optimisation of Controlled Human Malaria Infection Using Sporozoites Administered by Needle and Syringe
This is an open label, human pilot study to optimise controlled human malaria infection (CHMI) administered by Plasmodium falciparum sporozoites (PfSPZ. Volunteers will be inoculated with PfSPZ Challenge.
- Trial name
- NCT01465048
- Testing
- Plasmodium falciparum sporozoites 2sites, Plasmodium falciparum sporozoites 1 site, Plasmodium falciparum sporozoites 1site
- Where
- United Kingdom
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Oxford
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
A Challenge Study to Assess the Safety, Immunogenicity and Efficacy of a Malaria Vaccine Candidate
This is an open-label, multi-centre Phase I/IIa dose escalation blood-stage malaria CHMI trial to assess the safety, immunogenicity and efficacy of the candidate malaria vaccine RH5.1/AS01.
- Trial name
- NCT02927145
- Testing
- RH5.1/ ASO1
- Where
- 2 sites in United Kingdom
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Plasmodium Falciparum Malaria
Phase 1 Trial of a Malaria Vaccine in Young Kenyan Children
To assess the safety and reactogenicity of the FMP-1/AS02A malaria vaccine in malaria-exposed children living in western Kenya and aged 12-47 months
- Trial name
- NCT00317473
- Testing
- FMP1/AS02A Malaria vaccine, Imovax Rabies vaccine
- Where
- Kenya
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Malaria
Effectiveness of OZ439 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Volunteers
A single centre, open, controlled study using Blood Stage Plasmodium falciparum challenge inoculum (BSPC) as a model to assess the effectiveness of three dose levels of the experimental anti-malarial product, OZ439.
- Trial name
- NCT02453581
- Testing
- OZ439
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Malaria, Falciparum, Malaria, Vivax
Efficacy, Tolerability, PK of OZ439 in Adults With Acute, Uncomplicated P.Falciparum or Vivax Malaria Mono-infection
A Phase IIa Exploratory, Open label, Single Dose Regimen, Multiple Dose Testing Clinical Study to Assess the Preliminary Efficacy, Tolerability and Pharmacokinetics of OZ439 in adult patients with acute, uncomplicated Plasmodium…
- Trial name
- NCT01213966
- Testing
- OZ439
- Volunteers
- 82 people
- 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
Malaria,Falciparum, Plasmodium Falciparum
Safety and Protective Efficacy of Pb(PfCS@UIS4)
In the underlying study, a genetically modified P. berghei parasite is used. P. berghei is one of the four Plasmodium species that causes malaria in rodents. The hypothesis is that immunization of humans with P.
- Conditions
- Malaria,Falciparum, Plasmodium Falciparum, Plasmodium Berghei, Controlled Human Malaria Infection (CHMI)
- Trial name
- PbVac (NCT03138096)
- Testing
- Pb(PfCS@UIS4)-infected mosquitoes, Challenge infection P. falciparum
- Where
- 2 sites in Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Malaria,Falciparum, Gametocytes
Controlled Human Malaria Infection Model for Evaluation of Transmission-blocking Interventions - Study 2
This is a single-center, open label study. The primary aim of this project is to develop a controlled human malaria infection transmission model ("CHMI-trans") or "challenge model" to evaluate the capacity of vaccines, biologics…
- Conditions
- Malaria,Falciparum, Gametocytes, Controlled Human Malaria Infection, Transmission
- Trial name
- CHMI-trans2 (NCT03454048)
- Testing
- Piperaquine (low dose), Piperaquine (high dose), Sulfadoxine pyrimethamine
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
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
Plasmodium Falciparum
Study of Malaria Vaccine RTS,S/AS01E in Plasmodium Falciparum-infected and Uninfected Adults Pre-treated With Anti-malarial Therapy
The main goal of this study is to assess the efficacy of RTS,S/AS01E, a candidate vaccine against malaria caused by Plasmodium falciparum (P. falciparum), in adults positive for P.
- Trial name
- NCT04661579
- Testing
- Malaria Vaccine RTS,S/AS01E, Abhayrab rabies vaccine, Dihydroartemisinin-piperaquine (DHA/Pip)
- Where
- Kenya
- Volunteers
- 620 people, healthy volunteers welcome
- Sponsor
- PATH
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
Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.
KAE609 will be evaluated primarily for hepatic safety of single and multiple doses in sequential cohorts with increasing doses.This study aims to determine the maximum safe dose of the investigational drug KAE609 in malaria…
- Trial name
- NCT03334747
- Testing
- KAE609, Coartem
- Where
- 9 sites in Gabon, Ghana and 3 more
- Volunteers
- 188 people
- Sponsor
- Novartis Pharmaceuticals