Malaria

Researchers are evaluating the safety and feasibility of a controlled human Plasmodium vivax malaria infection CHMI in healthy adult Thai volunteers. This study aims to find the best dose of cryopreserved P. vivax infected red blood cells for future studies by experimentally injecting these infected cells into volunteers. The study involves up to 48 participants, who will be closely monitored in a hospital setting, with the goal of understanding the infection process and treatment responses. Participants will receive one of four doses of infected red blood cells, ranging from a whole vial to diluted amounts, administered by injection. Each dose will be tested in groups of volunteers to identify which dose reliably produces infection. The study includes a screening period, a challenge day for infection, a monitoring phase until treatment criteria are met, and a follow-up period lasting one year after treatment. Volunteers will be admitted to the hospital for close monitoring, including daily health checks and blood tests to detect malaria parasites and assess immune responses. After infection is confirmed, blood samples will be taken twice daily until participants meet treatment criteria, at which point antimalarial drugs will be given. Follow-up visits will occur over the next year to monitor health, immune response, and possible parasite transmission. Safety and infection outcomes will be analyzed throughout the study period.

Researchers are evaluating the safety, tolerability, and how the body processes pharmacokinetics single and multiple intravenous doses of a drug called BWC0977 in healthy adult volunteers. This Phase 1 study involves a total of 64 healthy adults aged 18 to 55 years and is designed as a randomized, double-blind, placebo-controlled trial with multiple dose groups. The study focuses on measuring any treatment-emergent adverse events and serious adverse events to understand the drugs safety profile. Participants will be divided into two main groups single ascending dose SAD and multiple ascending dose MAD cohorts. In the SAD phase, volunteers receive one intravenous infusion of BWC0977 or placebo over 2 hours at doses of 750 mg or 1500 mg. In the MAD phase, participants receive multiple intravenous infusions of BWC0977 or placebo over 30 minutes to 2 hours daily for 7 to 10 consecutive days. Dose levels will increase sequentially based on safety and tolerability data collected during the study. During the study, participants will undergo various assessments including physical exams, vital signs, ECGs, laboratory tests, and blood sampling at specific times before, during, and after infusions to monitor safety and measure drug levels in the body. Researchers will track adverse events for up to 8 days after single dosing and up to 16 days after multiple dosing. Volunteers must comply with study visits and requirements throughout the trial, which lasts until August 2026.

Researchers are evaluating a new strategy to improve the rapid and accurate identification of febrile children aged 2 to under 5 years at risk of life-threatening infections in sub-Saharan Africa. The study compares the current standard of care using IMCI-based guidelines to a new method that adds a rapid point-of-care test measuring suPAR biomarker levels. The goal is to see if this combined approach leads to better decisions about hospital admission, referral, or discharge, and ultimately improves health outcomes. The trial involves two groups one receiving standard IMCI-based care and the other receiving IMCI-based care enhanced by suPAR testing. Blood samples will be taken from all children, but only those in the suPAR group will have their suPAR levels measured on-site using a special device. Decisions about admitting or discharging children during the first clinical assessment will be guided by these results, especially for those with higher suPAR levels indicating greater risk. A second clinical assessment by an independent physician will help ensure safety and confirm decisions. Participants will be monitored with follow-up visits on days 3 and 7 after enrollment, plus additional check-ins if their condition worsens. A 28-day follow-up interview will track serious events, hospitalizations, or deaths, with an optional 3-month follow-up for further health status updates. Throughout the study, children will receive routine treatments as needed. Researchers will measure the appropriateness of discharge decisions, hospital referrals, survival, symptom duration, and other health outcomes to assess the new triage method.

Researchers are evaluating a revised weight-based dose of tafenoquine target dose 7.5mgkg to treat patients with vivax malaria. This Phase 3 trial aims to determine if this revised regimen is not worse than a high dose of primaquine given over seven days and if it is better than the standard fixed dose of tafenoquine. The study also looks at how well patients tolerate the revised dose and whether it is practical to use. Participants will be randomly assigned to one of three groups. One group will receive a single weight-based oral dose of tafenoquine along with schizontocidal treatment. Another group will receive a single fixed oral dose of 300mg tafenoquine plus schizontocidal treatment. The third group will receive schizontocidal treatment plus a high dose of primaquine given orally over seven days. The trial will monitor safety and effectiveness over several months. During the study, participants will be followed for six months. Researchers will assess the occurrence of vivax parasitaemia at 4 and 6 months as the main outcome. Other measurements include symptomatic vivax parasitaemia, anemia incidence at different time points, hemoglobin changes, adverse events, and methemoglobin levels. Participants must provide informed consent and live in the study area to allow regular follow-up and monitoring throughout the trial.

Researchers are evaluating the safety and immune response of a multi-stage malaria vaccine candidate combining R21 with RH5.1 andor R78C in Matrix-M adjuvant. This Phase Ib open-label study includes healthy adults aged 18 to 35 years and children aged 5 to 17 months in Burkina Faso. The study aims to test different combinations of these vaccines to better understand their effects in populations living in malaria-endemic areas. Participants are divided into six groups. Adults receive three doses of 5 g R21 plus 10 g RH5.1 and 10 g R78C. Children receive different combinations of 5 g or 10 g doses of R21, RH5.1, and R78C vaccines. Each participant receives three intramuscular injections at months 0, 1, and 6, either in the deltoid muscle for adults or the anterolateral thigh for children. Safety monitoring includes staggered recruitment, sentinel participants, and Data Safety Monitoring Board reviews before age de-escalation and subsequent vaccinations. Participants will undergo safety assessments for solicited and unsolicited adverse events at multiple time points up to one year following the first vaccination. Blood samples for immunology testing will be collected at screening, vaccination days, and several follow-ups up to day 365. The study includes ongoing monitoring of serious adverse events and immune responses to evaluate how well the vaccine combinations are tolerated and stimulate the immune system over time.

Researchers are studying the safety and immune response of different dosing schedules and reduced doses of the RTS,SAS01E malaria vaccine in healthy children aged 5 to 60 months living in areas where malaria is common. This Phase 2a open-label randomized study aims to find the best vaccination regimen to protect young children against malaria, a serious infectious disease. The study is sponsored by GlaxoSmithKline and targets healthy children who have completed routine immunizations. Participants are randomly assigned to receive three doses of the RTS,SAS01E vaccine on one of three schedules Day 1, Month 1, and Month 2 Day 1, Month 1, and Month 7 or Day 1, Month 2, and Month 7. The vaccine is given as an injection into the muscle. The study follows participants for up to 19 months to compare immune responses and safety across these different dosing schedules. During the study, children will have blood tests at multiple time points to measure antibodies against malaria and hepatitis B, along with monitoring for any side effects following vaccination. Researchers will track any adverse events, including serious ones, for up to 19 months after the first dose. Parents or guardians will complete diaries and attend follow-up visits to help monitor health and vaccine effects throughout the study period.

Researchers are evaluating the effectiveness, safety, and tolerability of a new fixed-dose triple combination therapy called artemether-lumefantrine-amodiaquine ALAQ compared to two existing artemisinin-based combination therapies ACTs for treating uncomplicated Plasmodium falciparum malaria. This open-label, randomized, controlled trial aims to determine whether ALAQ works as well and is as safe and tolerable as the current standard two-drug treatments. The study includes participants from Africa and Asia, with some sites incorporating a single low-dose primaquine treatment depending on local policies. Participants will be randomly assigned to one of three treatment groups ALAQ, artemether-lumefantrine AL, or artesunate-amodiaquine ASAQ. Treatments are given under direct observation over three days, with ALAQ and AL administered in six doses spaced between the start time and 60 hours later, while ASAQ is given once daily for three days. Participants stay in an inpatient unit for the first three days to receive treatment and undergo study procedures, followed by weekly visits up to day 42 for monitoring. During the study, researchers will perform daily malaria parasite counts, physical exams, vital sign checks, symptom questionnaires, and laboratory tests including blood counts, liver and kidney function, and heart monitoring with electrocardiograms. Pharmacokinetic studies and parasite genetic testing will also be conducted to understand drug levels and resistance patterns. Safety, efficacy at 28 and 42 days, and treatment tolerability will be closely tracked. Participants may visit the clinic between scheduled visits if they experience any symptoms. The total participation lasts up to 42 days from treatment start.

Researchers are evaluating the safety, immune response, and effectiveness of two blood-stage malaria vaccine candidates, RH5.1 in Matrix-M and RH5.2-VLP in Matrix-M, in infants aged 5 to 17 months living in Burkina Faso. This Phase IIb randomized controlled trial compares these vaccines against a rabies vaccine control to determine their ability to protect against malaria in a region where malaria is common. Participants will be randomly assigned to receive either the rabies vaccine, RH5.1 with Matrix-M, or RH5.2-VLP with Matrix-M. Vaccinations are administered in three doses on specific schedules some groups receive doses on days 0, 28, and 56, while others receive the third dose later at day 152. Each dose contains a specific amount of the vaccine antigen combined with Matrix-M as an adjuvant. The study follows participants for 12 months after the last vaccination to monitor outcomes. During the study, infants will be closely monitored for malaria cases, vaccine safety, and immune responses through blood tests and clinical evaluations at multiple time points including before vaccination, after each dose, and during follow-up visits up to a year post-vaccination. Researchers will assess protection against clinical and asymptomatic malaria, immune responses, and blood-related complications. Safety checks occur monthly after vaccinations and at 6 and 12 months post-final dose to ensure participant well-being throughout the trial.

Plasmodium vivax malaria is a common and serious cause of illness in tropical regions, especially in Southeast Asia where it accounts for over half of the global burden. This malaria type can relapse multiple times due to dormant liver forms, leading to severe health issues including anemia and pregnancy loss. The trial aims to determine if a higher 450 mg dose of tafenoquine combined with Artemisinin Combination Therapies ACTs is effective for treating P. vivax malaria, especially where chloroquine resistance limits treatment options. Participants will receive one of three treatments dihydroartemisinin-piperaquine plus 450 mg tafenoquine, chloroquine plus 450 mg tafenoquine, or artemether-lumefantrine plus 450 mg tafenoquine. Each drug combination is given using specific dosing schedules, such as weight-based doses of dihydroartemisinin-piperaquine over three days or chloroquine doses spread over three days. Tafenoquine is administered as a single 450 mg dose to improve convenience and adherence compared to traditional 14-day primaquine treatment. During the study, participants with confirmed P. vivax malaria will be monitored over four months with regular safety checks, blood tests, and pharmacokinetic assessments. Quantitative tests for G6PD enzyme activity will screen for risks before tafenoquine use. The main outcome is to compare the effectiveness of ACT plus tafenoquine against chloroquine plus tafenoquine in preventing malaria relapse. Researchers will also evaluate drug safety, tolerability, and oxidative activity over several time points.

This research aims to understand how eosinophils, a type of white blood cell, become activated and their role in immune responses. Eosinophil counts often increase due to allergies, asthma, parasitic infections, autoimmune conditions, or rarely, tumors. Elevated eosinophil levels, called eosinophilia, usually cause no symptoms but can sometimes lead to swelling, itching, allergic lung problems, heart disease, or nerve damage. Participants with eosinophil counts over 750ml or abnormal eosinophil buildup in skin or tissues, aged 1 to 100 years, will undergo clinical evaluations including medical history, exams, and blood tests. Additional testing may include studies of eyes, lungs, skin, bone marrow, nerves, or heart depending on symptoms and age. This is an observational study without experimental treatments patients needing therapy will get standard care. Some participants may also undergo bone marrow biopsy, genetic testing, or leukapheresis for adults for research purposes. During the study, participants will donate blood samples for laboratory studies and may have annual follow-ups with exams and blood tests to track eosinophil levels and condition changes. Researchers will collect samples like blood, bone marrow, tissue, and body fluids to study disease mechanisms, biomarkers, and treatment responses. The study will monitor clinical and immunological responses to therapy and evaluate family members to explore genetic causes of eosinophilia. The main goal is to better understand eosinophilic disorders and improve diagnosis and treatment options.