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PLASMODIUM FALCIPARUM MALARIA clinical trials

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NCT ID: NCT02792816 Completed - Clinical trials for Plasmodium Falciparum Malaria

Molecular Surveillance of Artemisinin Resistance Malaria in Myanmar

Start date: June 2009
Phase: N/A
Study type: Observational

Efficacy and safety of the artemisinin combination therapy (ACT) in uncomplicated falciparum malaria patients in Myanmar and artemisinin molecular markers analysis

NCT ID: NCT02614404 Completed - Clinical trials for Plasmodium Falciparum Malaria

Effect of Imatinib on Suppression of Malaria Parasites in Patients With Uncomplicated Plasmodium Falciparum Malaria

MIM
Start date: November 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of imatinib in combination with dihydroartemisinin plus piperaquine in the treatment uncomplicated P. falciparum malaria in adult male patients.

NCT ID: NCT02450578 Completed - Clinical trials for Plasmodium Falciparum, Malaria

DSM265 Chemoprophylaxis of Plasmodium Falciparum Malaria

Start date: October 2015
Phase: Phase 1
Study type: Interventional

Study to evaluate the efficacy of DSM265 as a causal prophylactic in a standardized and validated Human Challenge model using direct venous inoculation of aseptic, purified, cryopreserved, vialed Plasmodium falciparum sporozoites.

NCT ID: NCT02252640 Completed - Clinical trials for Plasmodium Falciparum Malaria

A Safety and Efficacy Study of Concomitant Administration of ChAd63/MVA ME-TRAP + RTS,S

Start date: January 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess two types of new malaria vaccines in different combinations. The study will enable us to assess: 1. The ability of the vaccines to prevent malaria infection. 2. The safety of the vaccines in healthy participants. 3. The response of the human immune system to the vaccines. We will do this by giving 48 participants three sets of vaccinations over 8 weeks, then exposing them to malaria infection by allowing mosquitoes infected with malaria to bite under carefully regulated conditions. We will follow participants closely to observe if and when they develop malaria. If the vaccine combination provides some protection against malaria, participants will take longer to develop malaria than usual or will not develop malaria at all. We will also recruit 4 individuals to be control subjects - these participants won't receive any vaccinations but will be challenged with malaria. Vaccinated volunteers who do not develop malaria infection in the blood after being infected with malaria by mosquito bite the first time may be invited back to be again infected with malaria in a repeat challenge experiment. This would happen approximately 5-7 months after the first challenge. The purpose of this second challenge will be to see how long the protection of the investigational vaccine against malaria lasts.

NCT ID: NCT02237586 Completed - Malaria Clinical Trials

Effect of Plasmodium Falciparum Exposure and Sickle Cell Trait on Infection Rates and Kinetics After IV Administration of PfSPZ Challenge

Start date: July 2014
Phase: Phase 1
Study type: Interventional

The study is designed to establish infectivity of Plasmodium falciparum sporozoites (PfSPZ) via intravenous (IV) administration in three groups with different malaria immunity-status: 1. Adults with a history of lifelong malaria exposure without sickle cell trait (HbAA) 2. Adults with a history of lifelong malaria exposure with sickle cell trait (HbAS) 3. Adults without previous malaria episodes without sickle cell trait (HbAA) Initially a dose of 3,200 PfSPZ will be given and the time until thick blood smear positivity after challenge will be assessed. If in any of the groups with a history of lifelong malaria exposure, 50% or less of individuals become thick blood smear positive during the 28 days post injection of PfSPZ Challenge, the dose will be increased 4-fold to 12,800 PfSPZ in this group.

NCT ID: NCT02132299 Completed - Malaria Clinical Trials

Dose Escalation, Randomized Controlled Trial to Evaluate the Safety, Immunogenicity and Efficacy of Intravenously Administered Attenuated Plasmodium Falciparum Sporozoite Vaccine (PfSPZ Vaccine) in Tanzanian Adults

Start date: April 2014
Phase: Phase 1
Study type: Interventional

This trial will evaluate whether relatively non-immune populations in endemic countries can effectively generate significant cellular and humoral immune responses that confer protection against P. falciparum infection after inoculation of aseptic, purified, vialed, metabolically active, non-replicating (live, radiation attenuated) Plasmodium falciparum sporozoites (PfSPZ Vaccine) administered intravenously (IV).

NCT ID: NCT02123290 Completed - Clinical trials for Plasmodium Falciparum Malaria

DSM265 Phase IIa Investigation Treating Plasmodium Falciparum or Vivax

Start date: January 2016
Phase: Phase 2
Study type: Interventional

This will be a Proof-of-concept / Phase IIa, open label study to examine the efficacy of DSM265 in uncomplicated Plasmodium vivax and Plasmodium falciparum blood-stage malaria in adult patients. A minimum of two cohorts (20 patients) and a maximum of 6 cohorts (60 patients, 3 dose levels) will be tested. The starting dose of DSM265 for the first P. vivax and P. falciparum cohorts will be 400 mg. This dose is expected to show complete clearance of parasites by microscopy by Day 7 and a decrease in recrudescence rate assessed at Day 14 (success criteria for dose de-escalation and continuation of the study).

NCT ID: NCT02115516 Completed - Malaria Clinical Trials

Safety and Protective Efficacy of Intravenous Immunization With Cryopreserved Plasmodium Falciparum Sporozoites Under Chemoprophylaxis

Start date: April 2014
Phase: Phase 1
Study type: Interventional

TÜCHMI-002 is a single center, randomized, placebo-controlled, double-blinded, PfSPZ Challenge dose finding trial with two chemoprophylactic regimens and subsequent controlled human malaria infection (CHMI).

NCT ID: NCT02089841 Completed - Clinical trials for Plasmodium Falciparum Malaria

Efficacy of Artemether/Lumefantrine for the Treatment of Uncomplicated Malaria.

ALE
Start date: May 2012
Phase: Phase 4
Study type: Interventional

Artemether-lumefantrine has been used in Tanzania as first-line treatment for uncomplicated malaria since 2007. Nonetheless, a report of increased proportion of patients with parasitaemia on day 1 following treatment with artemisinin based combination therapies has emerged from Kenya. Similarly, resistance against artemisinins has been confirmed in South-East Asia and it can spread to Africa. Therefore, the purpose of this study was to assess the efficacy of Artemether-lumefantrine for the treatment of uncomplicated malaria among children after five years of wide scale use of the drug in Tanzania.

NCT ID: NCT02044198 Completed - Clinical trials for Plasmodium Falciparum Malaria

A Phase I/IIa Study of the Safety, Immunogenicity and Efficacy of FMP2.1/AS01B, an Asexual Blood-Stage Vaccine for Plasmodium Falciparum Malaria

Start date: March 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate an experimental malaria vaccine for its ability to prevent malaria infection or disease in a blood-stage challenge model (when volunteers are infected with malaria parasites using malaria-infected red blood cells). The vaccine being testing is a protein called FMP2.1, which is given with an adjuvant (a substance to improve the body's response to a vaccination) called AS01B. The aim is to use this protein and adjuvant to help the body make an immune response against parts of the malaria parasite. This study will enable assessment of: 1. The ability of the vaccine to prevent malaria infection. 2. The safety of the vaccine in healthy participants. 3. The response of the human immune system to the vaccine. This will be done by giving participants three vaccinations and then exposing them to malaria infection by transfusing a small number of red blood cells infected with malaria under carefully regulated conditions. Participants will be followed closely to observe if and when they develop malaria. If the vaccine provides some protection against malaria, participants will take longer to develop malaria than usual or will not develop malaria at all. The study will enrol 15 participants to be vaccinated and then challenged with malaria in addition to recruit 15 individuals to be control subjects.