Clinical Trials for Malaria

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Malaria from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 13
• Active, not recruiting: 6
• Completed: 20
• Other: 11

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT01168271 — Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali

Malaria caused by Plasmodium falciparum continues to be a global problem with devastating consequences. A greater understanding of the immunologic and parasitologic factors associated with infection and disease is badly needed; and will accelerate the development of highly protective vaccines for both mothers and children. Pregnancy malaria is associated with low birth weight, maternal anemia, …

NCT02471378 — Laboratory Evaluation of Pregnancy Malaria Vaccine Candidates/In-vitro Testing of Pregnancy Malaria Vaccine Candidates

Background:

- Malaria is a disease that affects many people in African countries. It is caused by germs that are spread by mosquito bites. It can be fatal if not diagnosed and treated right away. Children younger than 5 and pregnant women are most at risk to get malaria. Researchers want to create a vaccine that will prevent malaria infection during pregnancy.

Objectives:

- To create a vac…

NCT02639299 — Screening of Healthy Volunteers for Investigational Antimalarial Drugs, Malaria Vaccines, and Controlled Human Malaria Challenge

Background:

Malaria is a serious infection caused by a parasite. People get malaria when an infected mosquito bites them. Malaria can cause major health and social problems in places were malaria is common, such as Africa but can also affect travelers who have never been exposed to malaria. Researchers at the NIH want to find a safe and effective malaria vaccine, antimalarial drugs, or prevent…

NCT03937817 — Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants

Background:

Blood disorders like sickle cell disease and malaria affect many people around the world. Researchers want to learn more about blood disorders. To do this, they need to collect biological samples from people with blood disorders. They also need to collect samples from healthy people.

Objective:

To collect samples to use for research on blood disorders.

Eligibility:

People ages …

NCT05478720 — DON in Pediatric Cerebral Malaria

The goal of this clinical trial is to evaluate the safety of a single intravenous dose of DON in healthy adults, adults with uncomplicated malaria, and children 12 months-14 years old with clinically defined Cerebral Malaria. The main objectives are:

• Evaluate the safety of a single intravenous dose of DON in healthy adults and adults with uncomplicated malaria ( Part 1)
• Determine the safet…

NCT05690841 — FocaL Mass Drug Administration for Vivax Malaria Elimination

FLAME is an open-label cluster-randomized controlled trial that aims to determine the effectiveness of focal mass drug administration (fMDA) to reduce the incidence of Plasmodium vivax malaria in the Loreto Department in Peru. Standard interventions, including symptomatic and asymptomatic screening for malaria infections, provision of insecticide-treated bednets, and environmental transmission …

NCT06607003 — Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Challenge Agent and Evaluate Transmission in Mosquito Feeding Assays

Background:

Malaria is a disease caused by parasites transmitted to people by mosquitoes. Around the world, there were 241 million cases and 627,000 deaths from malaria in 2020. Researchers are working to develop vaccines and treatments for this disease.

Objective:

To learn how malaria develops in people; how the body’s immune system reacts to malaria; and how malaria spreads from people to …

NCT06879327 — Infant Malaria Vaccine Schedule Optimization

The aim of this study is to identify an optimal infant vaccine schedule for a malaria vaccine which is better aligned with the timing of other vaccine interventions.

NCT07038837 — Comparison of Two Strategies for Administering the R21-Matrix M Vaccine in a Context of Seasonal Malaria Transmission in Chad

This is a two-arm, cluster-randomised, phase IV trial conducted in Chad to assess the protective efficacy and impact in real-life conditions of a new strategy for administering the R21/MM malaria vaccine, synchronized within a seasonal malaria chemoprevention (SMC) campaign, among children living in areas of high seasonal malaria transmission.

In this study, a cluster is defined as the catchme…

NCT07011511 — Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of LAI MMV055 Alone and in Combination With MMV371 in Healthy Participants

This is a single-centre, participant- and investigator-blind, randomised, placebo controlled, single ascending dose study to assess the safety, tolerability and PK of a single dose of IM depot injection(s) of LAI formulations of MMV055 administered alone (Part A) and in combination with MMV371 (Part B) in healthy participants.

It is planned to enroll up to 6 sequential cohorts of 8 healthy mal…

NCT07559370 — Safety and Efficacy of Imatinib in Combination With Artemether-Lumefantrine for Uncomplicated Malaria

This study is investigating an innovative approach to treating uncomplicated malaria by adding a drug called Imatinib to the current standard of care, Artemether + Lumefantrine (AL). The researchers hope this combination, known as ALIM, will clear infections faster and stop the spread of drug-resistant parasites that are becoming a major threat in Africa

NCT06862453 — Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults

This is a randomized, double-blind, placebo-controlled Phase 1 trial of Plasmodium falciparum (Pf) sporozoite (SPZ) late-arresting replication-competent (LARC) malaria vaccine (PfSPZ-LARC2 Vaccine) administered to healthy, malaria-naive study participants in Germany by direct venous inoculation (DVI) to determine safety, tolerability, and vaccine efficacy (VE) against controlled human malaria i…

NCT07385287 — Field Trial of PfSPZ-LARC2 Vaccine in Burkinabe Adults

This is a phase 2 clinical trial of a Plasmodium falciparum (Pf) late liver stage-arresting replication-competent (LARC) sporozoite (SPZ) vaccine (Sanaria® PfSPZ-LARC2 Vaccine) that will assess field efficacy in Africa.

The PfSPZ comprising PfSPZ-LARC2 Vaccine contain a double deletion of the genes encoding the Mei2 and LINUP proteins, both of which are required for transition from liver to bl…

Active, Not Recruiting

NCT04978272 — Modifying Immunity in Children With DihydROartemisinin-Piperaquine (MIC-DroP)

The MIC-DroP trial will test the hypothesis that preventing early life blood-stage malaria antigenic exposure with intermittent preventive therapy (IPT) enhances protective immunity to malaria. This study will take advantage of a unique opportunity to study infants born to mothers followed in a NIH-funded randomized controlled trial of novel intermittent preventive therapy in pregnancy (IPTp) r…

NCT05676645 — Pharmacokinetics of Antimalarials in Breastfeeding Ugandan Mother-infant Pairs

Lactating women requiring treatment for uncomplicated malaria will be identified and invited for sampling. The decision to treat them with first-line treatment will have been made by the clinician, not by a member of the study team. The study team will not make any adjustments to the prescribed treatment. Artemether-lumefantrine comprises six doses of medication, with the initial two doses give…

NCT05757167 — Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics

The purpose of the INTREPiD study is to compare 1st trimester screening for malaria parasites with a high-sensitivity malaria rapid diagnostic test followed by treatment of test-positive women with artemether-lumefantrine (AL) against usual antenatal care on a composite adverse pregnancy outcome including low birth weight, small for gestational age, preterm, fetal loss, or neonatal death.

NCT06320535 — A Phase 1 Study to Assess an Escalating Dose, Multi-prime Vaccination Schedule of R21/Matrix-M™

This is a phase I clinical study that aims to assess the safety and immunogenicity of a novel, escalating dose regimen of R21/Matrix-M™ in healthy, malaria-naïve adults.

NCT06735209 — First-in-Human PfSPZ-LARC2 Vaccination/CHMI

This randomized, double-blind, placebo-controlled, Phase 1 trial will enroll up to 22 malaria-naïve, adult participants to test safety, tolerability, immunogenicity, and efficacy of the genetically attenuated Plasmodium falciparum sporozoite vaccine (PfSPZ-LARC2) Vaccine. PfSPZ-LARC2 Vaccine is a late-arresting, replication-competent whole Plasmodium falciparum sporozoite product. We hypothesiz…

NCT07147400 — Pfs230D1 + R21 in Matrix-M1 in African School Children and Adults

This is a Phase 2, randomized, double-blind, controlled study designed to evaluate the safety, tolerability, immunogenicity, vaccine efficacy, and functional activity of Pfs230D1-CRM197 conjugate vaccine with R21 nanoparticle vaccine formulated on Matrix-M1. Participants (9-50 years of age) will be drawn from Bancoumana and Donéguébougou, Mali and the surrounding areas.

Not Yet Recruiting

NCT07533136 — Tafenoquine Combinations for Improved Radical Cure Efficacy of Plasmodium Vivax

This study is to conduct a clinical trial of tafenoquine combinations to compare the rates of therapeutic efficacy of dihydroartemisinin-piperaquine or artemether-lumefantrine with tafenoquine to chloroquine plus tafenoquine in preventing recurrence of Plasmodium vivax over a 6-month period in adult subjects with uncomplicated P. vivax infection living in Thailand.

NCT07646353 — First-in-Human Dose-escalation of GSK4425689A: Safety, Tolerability, and PK in Healthy Adults

This study will assess the safety, tolerability, and pharmacokinetic properties of GSK4425689A monoclonal antibody (mAb) in healthy adults, when administered by either intravenous (IV) or subcutaneous (SC) routes.

NCT07558122 — Malaria CVD 36000; Gates INV090205

In order to control infections, the investigators must first detect them. Biosensor devices may allow early detection and intervention for infectious diseases, helping the investigators to recognize infections early, and allow for early treatment. This will lower transmission of infections and lower costs for treating someone who becomes ill. This is a study testing whether a wearable device su…

NCT07670377 — Drug-Interaction Assessment of GSK3772701 in Healthy Male and Female Participants Aged 18 to 55 Years

This study aims to evaluate whether GSK3772701 alters the pharmacokinetics (PK) of midazolam (MDZ), a standard probe substrate for the CYP3A4 enzyme. The findings are planned to be used to determine whether GSK3772701 acts as an inducer and/or inhibitor of CYP3A4 and will help guide recommendations for safe co-administration with CYP3A4 substrates.

NCT07430592 — This is a Clinical Study to Assess Whether the Combination of SJ733 and Tafenoquine Will be a Safe and Rapidly Acting Anti-malarial for the Radical Cure of P. Vivax Malaria

The goal of this Phase 2b study is to examine the safety and efficacy of the combination of SJ733, an investigational agent, and tafenoquine for the radical cure of uncomplicated P. vivax malaria monoinfection in adult participants and determine the contributions of SJ733 to the effect. SJ733 will be administered in a 1-, 2-, or 3-day treatment schedule in combination with a single dose of tafe…

NCT07675785 — PfSPZ-LARC2 Vaccine in Women of Child-bearing Potential (WOCBP) in Mali

A randomized double blind, placebo-controlled study to assess the safety, tolerability, immunogenicity, and protective efficacy of 1, 6, 29-day PfSPZ-LARC2 Vaccine regimen given at a dose of 2 x10^5 PfSPZ or placebo in healthy WOCBP, who are on pregnancy prevention during vaccination, but report plans to become pregnant in the near future.

Participants will be randomized into two arms. Arm 1:…

NCT07545681 — A Phase 2A Study of a Novel Antimalarial Pyrrolidinamide in Adult Patients With Uncomplicated P. Falciparum Malaria

The study will evaluate the safety and efficacy of a new antimalarial drug GSK3772701 (a pyrrolidinamide), using different doses and treatment durations, in adult participants with uncomplicated Plasmodium (P.) falciparum malaria.

NCT07246525 — Intermittent Preventive Treatment of Malaria in School-age Children to Decrease Community Transmission

The CRITICal study aims to estimate the effectiveness of intermittent preventive treatment in school children (IPTsc) with dihydroartemisinin-piperaquine (DP) for reducing community level malaria burden. Given that school-aged children are the primary drivers of transmission, the study hypothesis is that IPTsc will reduce this infectious reservoir and thus the burden of malaria in persons of al…

NCT07548021 — Safety and PK of MMV371 LAI in Healthy Adults and Adolescents in Rwanda

This Phase 1b study will assess the safety, tolerability and pharmacokinetics (PK, this measures the levels of study drug in the body) of a single injection of MMV371 in healthy adult and adolescent participants in Rwanda. MMV371 has been designed as a long acting injection (LAI). Protective efficacy (PE) will be assessed as an exploratory endpoint. Protective efficacy measures if participants …

Completed Trials

NCT04083508 — Vivax Malaria Human Infection Studies in Thailand

This study is a human challenge study to assess the feasibility and safety of controlled human malaria infection (via P. vivax sporozites) in healthy volunteers, and to develop a bank of P. vivax-infected blood for use in future controlled human P. vivax malaria infection studies. Additional objectives are to obtain data on host immune response to P. vivax infection and pre-treatment gametocyta…

NCT05052502 — Targeting High Risk Populations With Enhanced Reactive Focal Mass Drug Administration in Thailand

This study assesses the effectiveness of reactive focal mass drug administration (rfMDA), targeting both village and forest working populations, compared to control for reducing the health promotion hospital-level (sub-district) incidence and prevalence of P. falciparum and P. vivax within five provinces in Thailand.

NCT04546633 — 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 age) with uncomplicated P. falciparum malaria. There is an unmet medical need for anti-malarial treatment with a new mechanism of action to reduce the probability of d…

NCT04706130 — Rigorous Assessment of P. Vivax Relapses and Primaquine Efficacy for Radical Cure

The study will be an open-labelled randomized clinical trial to determine therapeutic efficacy. Note that this will not be an Investigational New Drug application, as only World Health Organization (WHO)-approved drugs will be used at dosage and for conditions approved.

NCT04529434 — Star Homes Project 2

Malaria, pneumonia and diarrhoea causes a lot of illness in children in Tanzania and the study want to find better ways of protecting people against these diseases and want to find out if the type of house design can affect the general health of children living in the house.

NCT04675931 — To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum Malaria

The purpose of this study was to identify the safe and effective dose of intravenous cipargamin in participants with moderately severe and severe malaria.

The study also intended to evaluate clinical treatment success using a novel clinical endpoint for drug development in severe malaria.

Severe malaria is a medical emergency and is affecting primarily young children in Africa. Injectable art…

NCT03503058 — Safety, Tolerability, Immunogenicity and Protective Efficacy of PfSPZ Vaccine and PfSPZ-CVac in Indonesian Adults Against Naturally-Transmitted Malaria

The study is a double-blind, randomized, placebo-controlled, Phase 2 clinical trial that will assess the safety, tolerability, immunogenicity and protective efficacy of PfSPZ Vaccine and PfSPZ-CVac against naturally occurring malaria in healthy Indonesian soldiers deployed to eastern Indonesia.

NCT05357560 — A Study to Assess the Experimental Malaria Vaccines RH5.2-VLP and R21

This is a Phase Ib multi-stage Plasmodium falciparum malaria vaccine study to assess the safety and immunogenicity of the blood-stage vaccine candidate RH5.2 virus-like particle (VLP) in Matrix-MTM and the pre-erythrocytic stage vaccine candidate R21 in Matrix-MTM, both alone and in combination, in adults and infants in the Gambia

NCT05874271 — Short Course Primaquine for the Radical Cure of P. Vivax - Papua New Guinea

Significant gains have been made in reducing the overall burden of malaria worldwide, however these have been far greater for Plasmodium falciparum than P. vivax.

P. vivax remains a major obstacle to malaria control and elimination efforts, largely due to its ability to form dormant liver stages (hypnozoites) that allows it to escape detection and treatment. Importantly, they are susceptible o…

NCT05891236 — Safety, Tolerability, Pharmacokinetics and Protective Efficacy of MAM01 in Healthy Adults

This is a First-in-Human (FiH), randomized, two-part, dose-escalation trial of MAM01 monoclonal antibody (mAb) targeting the Plasmodium falciparum (Pf) Circumsporozoite Protein (CSP). This study will evaluate the safety, tolerability, pharmacokinetics (PK), and protective efficacy of MAM01, as well as safety and PK of repeat subcutaneous (SC) dosing. Part A will have a double-blind, placebo-con…

NCT06069544 — A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria

This is a randomized, dose-escalation Phase I/IIa trial to evaluate safety, tolerability, immunogenicity and efficacy of an investigational RNA-based vaccine (BNT165e) for prevention of P. falciparum malaria in healthy malaria-naive adults.

The multi-antigen malaria vaccine (designated BNT165e) is a combination of three distinct RNAs, BNT165c and BNT165d (composed of BNT165d1 and BNT165d2), en…

NCT05750459 — Pharmacokinetic Study of IV Artesunate to Treat Children With Severe Malaria

This clinical study is a phase 4, single-site, open-label pharmacokinetic (PK) study of IV artesunate in up to 100 Ugandan children 6 months-14 years of age who are diagnosed with severe malaria according to standardized World Health Organization (WHO) criteria (any P. falciparum parasitemia and the presence of danger signs). Participants will receive the standard of care IV artesunate for init…

NCT06171113 — A Study to Investigate the Safety of GSK4024484 in Healthy Adult Participants

The primary purpose of the study is to characterise the safety of GSK4024484 in healthy participants within a controlled pharmacokinetic (PK) range, and the effect of food on the study intervention.

NCT07235033 — Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort B2)

This was Cohort B2 of the Platform study (NCT05750628) to evaluate the efficacy and safety of Cipargamin + KLU156 in participants with uncomplicated Plasmodium falciparum malaria.

NCT07527182 — Artemisinin Partial Resistance in Ethiopian Plasmodium Falciparum: A Multisite Clinical, Molecular and In Vitro Study

Artemisinin-based combination therapies (ACTs) are the main treatment for falciparum malaria in Africa. Artemisinin partial resistance (ART-R), characterized by delayed parasite clearance after treatment, has been confirmed in four sub-Saharan African countries. In Ethiopia, molecular surveys have detected the Pfkelch13 R622I mutation associated with ART-R at multiple sites, but no study has ye…

NCT06347471 — The Transmission of Artemisinin Resistant Parasites Before and After Conventional Artemisinin-combination Therapy

A prospective study will be carried out in an area where parasites with reduced sensitivity to malaria drugs (artemisinins) have recently emerged. The study will recruit participants from patients who attend the clinic with uncomplicated malaria and asymptomatically infected individuals. Participants are treated with conventional artemisinin-combination therapies (ACT) as part of standard clini…

NCT06558643 — Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV371 LAI in Healthy Participants

This four-cohort, first-in-human, healthy participant study aims to assess the test medicine’s safety and tolerability, including injection site reactions and how it is taken up by the body when given as a single dose.

For Cohort 1, up to 8 participants will be randomly assigned to receive the starting dose of the test medicine or dummy medicine (placebo) as a single intramuscular injection.

…

NCT06652737 — Age De-escalation Safety Trial of PfSPZ-LARC2 Vaccine in Burkina Faso

This is a first-in-humans randomized, double-blind, placebo-controlled, age de-escalation Phase 1 trial of Plasmodium falciparum (Pf) late liver stage-arresting replication-competent (LARC) sporozoite (SPZ) malaria vaccine (Sanaria® PfSPZ-LARC2 Vaccine) administered to healthy, malaria-exposed adults and children by direct venous inoculation (DVI) to determine safety, tolerability, and immunoge…

NCT06408857 — Study To Evaluate Safety, Tolerability, and Pharmacokinetics of MAM01 in African Population

This study will test a new drug (MAM01) to find which doses are safe and could help prevent people from getting malaria for at least 4 months. The study will take place in parts of Africa where malaria is common. Part A is an open-label study conducted in healthy adults whereas Part B is double-blind study conducted in young children and infants. Both the parts will evaluate the safety, tolerab…

NCT07060508 — L9LS in Women of Childbearing Potential in Mali

Safety and Efficacy of L9LS, a Human Monoclonal Antibody Against Plasmodium falciparum, in a Randomized, Double-Blind, Placebo-Controlled Trial of Women of Childbearing Potential (WOCBP) in Mali

Other (Withdrawn)

NCT04416945 — Targeting High Risk Populations With Enhanced Reactive Case Detection in Southern Lao Peoples Democratic Republic

This study assesses the effectiveness and feasibility of enhanced reactive case detection (RACD) targeting high-risk villages and forest workers for reducing Plasmodium falciparum and Plasmodium vivax transmission in southern Lao Peoples Democratic Republic. The authors hypothesize that enhanced community-based RACD will be more effective than standard of care case management and RACD at reduci…

Other (Suspended)

NCT05652504 — Safety Evaluation of PfSPZ Vaccine in Pregnant Women in Mali (MalVIP1)

Background:

Malaria is a disease that affects many people in Africa. It is caused by germs carried by some mosquitoes. A person bitten by an infected mosquito will get malaria. Most malaria infections cause only mild symptoms or none at all, but sometimes the disease can be deadly. Malaria can also harm pregnant women. They may lose their pregnancies or deliver too early, and the mother and ne…