View clinical trials related to Malaria.
Filter by:The purpose of this trial is to assess the safety and immunogenicity of AdCh63 ME-TRAP and MVA ME-TRAP candidate vaccines in healthy adult volunteers in a malaria endemic region. The regime proposed in this trial has protected non-immune volunteers against sporozoite challenge in clinical trials performed by Oxford, and so may be protective against naturally acquired infection in Kenya.The study population will comprise 30 healthy adult males aged 18-50. The investigators do not propose to include a placebo group. At this stage the investigators objective is to describe the safety profile in a small number of individuals, and the confidence intervals for the proportion of individuals with a particular event would be too wide for meaningful comparison with a placebo group. Immunogenicity will be judged by comparison with baseline.
Primary Objective: - To demonstrate the non-inferiority of corrected adequate clinical and parasitological response at Day 28 of Artesunate Amodiaquine (ASAQ) versus chloroquine Secondary Objectives: - To assess the non inferiority on the same way as the main criteria: - at Day 28 before corrected cure rate - at Day 14 and Day 42 before and after corrected cure rate - To compare the two groups of treatment in terms of: - Efficacy: - Proportion of aparasitaemic patients at 24, 48 an 72 hours - Proportion of afebrile patients at 24, 48 and 72 hours - Percentage of gametocyte carriers during follow-up - Evolution of the mean of gametocytes during the 42 days of follow-up - Evolution of haemoglobin value between Day 0 and Day 7, Day 0 and Day 28 - Clinical and biological tolerability: - Proportion of any adverse event - Biological safety: haematology (Red blood cells, Haemoglobin, White Blood Cells, neutrophils, platelets), biochemistry (creatinine, transaminases (alanine amino transferase/ALT), bilirubins) - ECG (electro encephalogram) (Day 0, Day 3,Day 28) only for patients 10 years old and above
The purpose of this two part study is to test the safety and efficacy of Tafenoquine (with Cholorquine) as a radical cure for Plasmodium vivax (P.vivax) malaria relative to the control Chloroquine.Part 1 aims to select an efficacious and well tolerated dose that can be co-administered with Chloroquine. Part 2 will investigate the safety and efficacy of the selected dose (300 mg tafenoquine) in the treatment and radical cure of Plasmodium Vivax Malaria.
This is a bi-centric phase IIIb, randomized, open label, 3-arm clinical trial performed to investigate the impact of retreatment with an Artemisinin-Based Combination (ACT), for example Arthemeter-Lumefantrine (AL) in Uganda (Ug) and artesunate-amodiaquine (ASAQ) in RDCongo, on malaria incidence and its potential selection of resistant strains. Patients will be followed-up for efficacy and safety during 42 days after treatment with the first line therapy recommended by the national authorities(arthemeter-lumefantrine in Uganda and artesunate-amodiaquine in RDCongo) and retreated the patients either with the same ACT or an other ACT or oral Quinine + clyndamicin. The investigators hypothesize that (re)treatment with the first line ACT treatment beyond 14 days is as efficacious as any other rescue treatment, without the risk of selecting drug resistant strains.
A randomized controlled trial to assess the safety and efficacy of azithromycin combination therapy for use in severe malaria. This pilot trial will be conducted in uncomplicated malaria patients in southeastern Bangladesh.
The purpose of this trial is to assess the safety and immunogenicity of MVA ME-TRAP and AdCH63 ME-TRAP candidate vaccines in healthy children and adult volunteers in a malaria endemic region. The regimen proposed here has protected non-immune volunteers in Oxford against sporozoite challenge, and so may be protective against naturally acquired infection in The Gambia.
This study will evaluate whether administration of two investigational malaria vaccines (257049 and Ad35.CS.01 vaccines) combined in one immunization schedule increases protection against malaria infection as compared to protection induced by the 257049 vaccine alone. The study will also evaluate the safety and the immune response to the new combination of the two experimental malaria vaccines.
The purpose of this study is to evaluate the safety and efficacy of lower doses of primaquine compared to the dose recommended by the WHO for reducing P. falciparum gametocytes in the infected human host to prevent transmission of falciparum malaria to the anopheles mosquito vector.
This is an open label phase I study, to assess the safety and immunogenicity of novel schedules for vaccination with the candidate malaria vaccines AdCh63 ME-TRAP and MVA ME-TRAP. These vaccines have been evaluated previously in a number of clinical trials proved to be safe and capable of inducing protective cellular immune response following challenge with the parasite. All volunteers recruited will be healthy adults. They will be primed with AdCh63 ME-TRAP administered intramuscularly and boosted several times with AdCh63 ME-TRAP and MVA ME-TRAP according to various schedules.. Safety data will be collected for each of the seven regimens. Secondary aims of this study will be to assess the immune responses generated by each of these regimes.
A vaccine which interrupts malaria transmission is a critical tool to achieve the ultimate goal of eradication of this disease. Transmission blocking vaccines work by inducing antibody in vaccinated individuals that inhibits the development of malaria parasites in the mosquito, thus interrupting the cycle of transmission to the next human host. Efficacy of these vaccines may be estimated by in vitro membrane feeding assays using immune sera and laboratory strain mosquitoes, but these assays need to be qualified to determine to what extent they are predictive of transmission blocking in the field. Clinical trials of transmission blocking vaccines are also anticipated and have started in this community. This protocol will use a nested casecontrol cohort design to compare results of mosquito feeding assays in a malaria exposed population in Bancoumana and surrounding villages in Mali. Households will be identified using census data and individuals will be consented for participation. Malaria smears will be obtained at monthly visits, and gametocytemic individuals will be asked to participate in direct feed experiments using insectary-raised mosquitoes. Infectivity in these mosquitoes will be compared against those of mosquitoes fed in membrane feeding assays in Mali and the USA. Data will also be obtained on gametocyte and parasite carriage rates through the year. A total of 250 volunteers from Bancoumana, ages 3 months to 50 years, were initially enrolled in 2011. In 2012, an additional 250 adults from Bancoumana were enrolled and participants older than 5 years of age who were enrolled in 2011 and wanted to continue participation were re-enrolled into the study. A transmission blocking vaccine trial started in May 2013, and has enrolled participants from this adult cohort in that study. Up to 50 new adults from Bancoumana and surrounding villages will be enrolled in 2014 and those volunteers previously enrolled into the study over theage of 5 years old will be offered re-enrollment into the study.