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Malaria clinical trials

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NCT ID: NCT03952650 Completed - Malaria Clinical Trials

Sanaria PfSPZ Challenge With Pyrimethamine or Chloroquine Chemoprophylaxis Vaccination (PfSPZ-CVac Approach): A Randomized Double Blind Placebo Controlled Phase I/II Trial to Determine Safety and Protective Efficacy Against Natural Plasmodium Falcipa...

Start date: May 23, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Malaria remains a major global health problem. Malaria is spread by the bite of mosquitos. Africa is the region of the world where most people get malaria. Sanaria PfSPZ Challenge is a malaria vaccine. Researchers want to see if the vaccine combined with partner drugs can help protect against malaria. Objective: To test if injections with 3 monthly doses of Sanaria PfSPZ Challenge, combined with either pyrimethamine (PYR) or chloroquine as a partner drug, is safe, tolerable, and effective. Eligibility: Healthy people ages 18-50 years who live in Bancoumana, Mali, or nearby Design: Participants will be screened with the Malaria Comprehension Exam to check their understanding of the study. They will have a medical history. They will have a physical exam. They will have blood tests, urine tests, and heart tests. Participants will join either the pilot study or the main study. Participants will be assigned to groups. Depending on their group, they will get at least one injection of either a placebo or the vaccine. They may have up to 3 vaccines, 4 weeks apart. The injection will be into a vein with a needle. Participants will also take pyrimethamine or chloroquine by mouth. They will also take standard doses of antimalarial drugs by mouth. Participants will have blood tests throughout the study. Participants may develop a rash or injection site reaction. If this happens, photos of the site may be taken. Participants will be observed for infection for many days after the injections.

NCT ID: NCT03939104 Completed - Clinical trials for Plasmodium Falciparum Malaria (Uncomplicated)

A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs Against Combinations of 2 Anti-malarial Drugs (Asia)

DeTACT-ASIA
Start date: June 30, 2021
Phase: Phase 3
Study type: Interventional

A partially blinded randomised controlled non-inferiority trial comparing the efficacy, tolerability and safety of Triple ACTs artemether-lumefantrine + amodiaquine (AL+AQ) and artesunate- mefloquine+piperaquine (AS-MQ+PPQ) with the ACTs artemether-lumefantrine + placebo (AL+PBO) and artesunate- mefloquine + placebo (AS-MQ+PBO) (with single-low dose primaquine in some sites) for the treatment of uncomplicated Plasmodium falciparum malaria to assess and compare their efficacy, safety, tolerability.

NCT ID: NCT03934450 Completed - Malaria Clinical Trials

Metabolism and Pharmacokinetics of Primaquine Enantiomers in Human Volunteers Receiving a Seven Day Dose Regimen

Start date: August 17, 2018
Phase: Phase 1
Study type: Interventional

To investigate the comparative tolerability, metabolism and pharmacokinetics of individual enantiomers of PQ in healthy human volunteers, receiving study drug over the course of 7 days.

NCT ID: NCT03917654 Completed - Malaria Clinical Trials

Pfs230D1M-EPA/AS01 Vaccine, a Transmission Blocking Vaccine Against Plasmodium Falciparum, in an Age De-Escalation Trial of Children and a Family Compound Trial in Mali

Start date: April 24, 2019
Phase: Phase 2
Study type: Interventional

Background: Malaria affects many people in Mali and other parts of Africa. It is spread by mosquito bites. Malaria can make people sick or can lead to death. Scientists want to learn if a vaccine can stop it from spreading to other people. Objective: To test how well an experimental malaria vaccine works to decrease malaria infections. Eligibility: Healthy people ages 5 and older who live in Doneguebougou, Mali, and surrounding areas Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests EKG Participants will be randomly assigned to get either the experimental vaccine or an approved vaccine. They will not know which they are getting. Participants will have a visit about a week before their first vaccine. They will take a medicine that kills malaria. They will take it at the clinic the next 2 days. Participants ages 5-8 will take the drug again 2 weeks before their third vaccine. Participants get the vaccine through a needle in the arm. They will have visits 1, 3, 7, and 14 days after. They will have blood tests or finger pricks. Participants will get another vaccine 1 and 6 months later. Participants will have blood tests once a month. At these visits they may also have urines tests or mosquito feeds. For the feeds a cup full of mosquitoes will be placed on arms or legs for 15-20 minutes. Participants will have visits twice a month for 4 months after their last vaccine.

NCT ID: NCT03916003 Completed - Malaria Clinical Trials

Reducing the Risk of P. Vivax After Falciparum Infections in Co-endemic Areas

PRIMA
Start date: August 18, 2019
Phase: Phase 4
Study type: Interventional

This study is designed as a multi-centre randomized, open label trial to compare the safety and efficacy of a high dose primaquine (PQ) treatment in G6PD normal patients with P. falciparum to reduce the risk of subsequent P. vivax episodes to current standard practice of providing only schizontocidal treatment.

NCT ID: NCT03906474 Completed - Malaria Clinical Trials

VAC063C: A Study to Assess Repeat Blood-stage P. Falciparum Infection

Start date: November 6, 2018
Phase: N/A
Study type: Interventional

This is a clinical study to assess the safety of primary, secondary and tertiary blood-stage controlled human Plasmodium falciparum malaria infection of healthy malaria-naïve UK adults, as well as to evaluate any effect of prior exposure to a blood-stage controlled human malaria infection (CHMI) on the parasite multiplication rate. As a secondary objective, the immune response to primary, secondary and tertiary P. falciparum blood-stage infection, as well as gametocytaemia, will also be assessed.

NCT ID: NCT03896724 Completed - Malaria,Falciparum Clinical Trials

Safety, Immunogenicity and Efficacy of R21 Matrix-M in 5-17 Month Old Children in Nanoro, Burkina Faso

Start date: May 7, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is a double blind randomised controlled clinical trial to evaluate the efficacy of R21 adjuvanted with Matrix-M in healthy 5-17 month old children in a malaria endemic area.

NCT ID: NCT03882528 Completed - Malaria,Falciparum Clinical Trials

Evaluate the Infectivity Equivalence of Current and New Lots of Plasmodium Falciparum Strain NF54

Start date: March 4, 2019
Phase: Phase 1
Study type: Interventional

Objectives: Primary: • To characterize the infectivity of the new lot of Plasmodium falciparum strain 3D7 within the standard WRAIR CHMI model as compared to the current lot (historical data) Secondary: - To assess safety of the new lot of P falciparum parasites - To assess the kinetics of detecting parasitemia and parasite clearance by quantitative polymerase chain reaction (qPCR) as compared to blood smear - To obtain plasma samples to restore the testing control pool for malaria serology testing and for future malaria research

NCT ID: NCT03874143 Completed - Malaria Clinical Trials

Clinical Evaluation of the Use of an mHealth Intervention on Quality of Care

Start date: March 1, 2016
Phase: N/A
Study type: Interventional

Under the World Health Organization's (WHO) integrated community case management (iCCM) Rapid Access Expansion Program (RAcE), World Vision Niger and Canada supported the Niger Ministry of Public Health to implement iCCM in four health districts in Niger in 2013. Community health workers (CHWs), known as Relais Communautaire (RCom), were deployed in their communities to diagnose and treat children under five years of age presenting with diarrhea, malaria and pneumonia and refer children with severe illness to the higher-level facilities. Two of the districts piloted RCom using smartphones equipped with an application to support quality case management and provide good timely clinical data. A two-arm cluster randomized trial assessed the impact of use of the mHealth application mainly on quality of care (QoC), but also on motivation, retention and supervision

NCT ID: NCT03867331 Completed - Malaria,Falciparum Clinical Trials

To Assess the Safety, Immunogenicity and Efficacy of VLPM01 in Healthy, Malaria-Naïve Volunteers

Start date: March 13, 2019
Phase: Phase 1
Study type: Interventional

This study is a proof-of-concept, first in human, Phase I, single center study designed to evaluate the safety, tolerability, immunogenicity and experimental efficacy of VLPM01 in healthy, malaria-naïve adult volunteers. The VLPM01 product will be adjuvanted with alhydrogel. The study design was based on the FDA's guidance "General Principles for the Development of Vaccines to protect Against Global Infectious Diseases" (2011).