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PLASMODIUM FALCIPARUM MALARIA clinical trials

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NCT ID: NCT00587249 Completed - Clinical trials for Plasmodium Falciparum Malaria

ICC-1132 - Candidate Vaccine Against P Falciparum Malaria

Start date: July 2002
Phase: Phase 1
Study type: Interventional

The purposes of this study are to evaluate the safety and immune responses (the body's defense system) to an investigational malaria vaccine called ICC-1132. Three different doses of the vaccine will be studied in 3 groups of people, and the results will be compared. The study will involve about 80 healthy volunteers, 18-45 years of age, who will receive an injection of a specific dose of the vaccine in their arm on 2 or 3 different days. Blood samples will be collected approximately 15 times for laboratory studies. Volunteers will record their temperature twice per day. Volunteers will complete a daily symptom diary for 7 days after each vaccination. Volunteers will participate in the study for up to 13 months.

NCT ID: NCT00484900 Completed - Clinical trials for Plasmodium Falciparum Malaria

Multi-Centre Trial Comparing Three Artemisinin-Based Combination Treatments on P. Falciparum Malaria

Start date: May 2006
Phase: Phase 3
Study type: Interventional

The purpose of this open randomised multi-centre clinical trial is to test the hypothesis that three pills of the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine, administered over 24 hours is not inferior in efficacy to the same drug administered over 48 hours and that the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine As/SMP fdc, independently of the duration of its dose interval, is not inferior in efficacy to 6 - 24 pills (number of pills administered to respectively children and adults)of the 60 hours treatment of artemether/lumefantrine for the treatment of uncomplicated P. falciparum malaria.

NCT ID: NCT00466557 Completed - Malaria Clinical Trials

Plasmodium Resistance in A. Gambiae

Start date: June 2007
Phase:
Study type: Observational

The purpose of this study is to find new ways to control malaria by looking at mosquitoes infected with the disease. Knowledge of the genetics that affect the spread of malaria by mosquitoes will help in developing control strategies. A small amount of blood from infected humans will be used to infect the mosquitoes. No contact will occur between the human subject and the mosquito. Study participants will be divided into 2 groups of 20, for a total of 40 children, ages 5-10, in Burkina Faso, West Africa. Each subject will be screened by finger-prick once per month, from June through October, until they reach a maximum age of 10. Two positive subjects of the 40 screened will be asked to donate about 1 teaspoon of blood, which will be used to feed and infect the mosquitoes. Study participants will be involved in study related procedures for a maximum of 5 years.

NCT ID: NCT00460525 Completed - Clinical trials for Plasmodium Falciparum Malaria

Phase II AMA-1 Malaria Vaccine FMP2.1/AS02A Trial in Mali

Start date: May 2007
Phase: Phase 2
Study type: Interventional

Malaria is a disease that affects many people in Africa. Malaria is caused by germs spread by mosquito bites. The purpose of this study is to compare the number of children who get malaria after receiving an experimental malaria vaccine (FMP2.1/AS02A) to the number of children who get malaria after receiving a vaccine for rabies (an approved vaccine that does not prevent malaria). The children will be assigned to one of the vaccine groups by chance. Participants and doctors will not know which vaccine was given. Study participants will include 400 children, ages 1-6 years, living in Bandiagara, Mali. Children will receive 3 vaccine doses, by injection, to their upper arm. Study procedures will include physical exams and several blood samples. Participants will be involved in the study for 26 months.

NCT ID: NCT00393757 Completed - Clinical trials for Plasmodium Falciparum Malaria

Malaria Transmission and Immunity in Highland Kenya

Start date: October 2006
Phase:
Study type: Observational

The purpose of this study is to see why malaria epidemics occur in highland areas in Kenya. A better understanding of factors contributing to malaria may be necessary for malaria vaccine planning. These factors include interactions between age, where malaria is passed from mosquitoes to people, immune system (how the body fights infection) responses and other factors that contribute to malaria in epidemic-prone areas. About 6400 people from the villages of Kapsisiywa and Kipsamoite will participate. Study procedures will include in home surveys, which will involve a census and an interview by researchers. Blood samples and smears will be collected from some volunteers in both communities to understand how the body protects itself from malaria and to check for malaria parasites. Twice each month, random houses will be selected from 3 places in the village to measure the number of mosquitoes in the home. Participants may be involved in the study for up to 4 years.

NCT ID: NCT00362050 Completed - Clinical trials for Plasmodium Falciparum Malaria

RBx11160 Phase II Dose Ranging Study RBx/MMV05-06

Start date: June 2006
Phase: Phase 2
Study type: Interventional

The trial will identify the best dose of the synthetic peroxide RBx11160 to treat uncomplicated malaria. Patients will be treated over 7 days with daily doses of 50, 100 or 200 mg RBx11160. The study is designed to assess the antimalarial activity and safety of 3 dose levels of RBx 11160 administered once daily for 7 consecutive days. The primary endpoint will be the time to 90% parasite clearance. In future regulatory studies, RBx 11160 is likely to be administered in combination with another antimalarial agent since the development plan follows the current recommendation of WHO for the treatment of uncomplicated malaria. However, it is critical to gather data on RBx 11160 when used as monotherapy in adult patients suffering from acute uncomplicated P. falciparum malaria. In malaria-endemic regions, an adult population is defined on the basis of immune status rather than the legal age of consent. Thus, patients as young as 13 years of age can be enrolled provided consent has been obtained from a legal guardian in accordance with local practices and regulations. This study will be conducted in compliance with International Conference on Harmonization (ICH) Good Clinical Practice (GCP).

NCT ID: NCT00358332 Completed - Clinical trials for Plasmodium Falciparum Malaria

Phase I Pediatric FMP2.1/AS02A Trial in Mali

Start date: November 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test the safety and dosages of a malaria vaccine in 100 children, 1-6 years old, in Bandiagara, Mali. The study is testing the safety of the vaccine when it is given to people who are regularly exposed to malaria and it will provide information regarding optimal vaccine dosage. This study will compare 3 injections of different vaccine doses to a rabies vaccine that is already approved. During the study, the child's health will be checked in the clinic and during home visits. Children may participate for about 14 months, and blood will be taken from each child throughout the study. If the child becomes sick from malaria, he/she will be treated. Information from this study may be used to develop a malaria vaccine that will help control the disease.

NCT ID: NCT00349713 Completed - Malaria Clinical Trials

FMP2.1 Trial in Bandiagara, Mali

Start date: November 2004
Phase: Phase 1
Study type: Interventional

Malaria is a disease that affects many people in Africa and in Mali. It is caused by germs that are spread by mosquito bites. This study will look at the safety, effectiveness, and best dose of an experimental malaria vaccine in people who are regularly exposed to malaria. Study participants will be 60 adults, 18-55 years old, who live in Bandiagara, Mali. Volunteers will get either 3 full doses of the experimental malaria vaccine, 3 half doses of the malaria vaccine, or a rabies vaccine that has been approved in Mali. (Rabies is an infection of the brain that usually causes death, and can be caught from being bitten by infected dogs or bats.) The 3 vaccinations will be given by injection into the upper arm 30 days apart. Volunteers will be enrolled in the study for approximately 12 months after the first vaccination. Volunteers will have 14 blood samples collected during the study for testing to make sure that the vaccine is not harmful and to measure the effect of the vaccine.

NCT ID: NCT00347555 Completed - Clinical trials for Plasmodium Falciparum Malaria

Safety and Immunogenicity of EBA-175 RII-NG Malaria Vaccine Administered Intramuscularly

Start date: May 2006
Phase: Phase 1
Study type: Interventional

Malaria is an illness caused by a parasite (an animal or plant that lives in or on a host) that enters the human body through the bite of an infected mosquito. The purpose of this study is to find out about the safety of an experimental malaria vaccine and whether the vaccine causes humans to produce antibodies (proteins made by the body's immune system to help control or prevent infection). Four strengths of the vaccine will be tested. The lowest strength of the vaccine will be tested before the next higher strength is tested. Each dosage (shot) of vaccine will be given to 18 people in 4 dosage groups on Day 0, at 1 month and at 6 months. Two people in each dosage group will receive injections of a placebo (contains no medication). Participants will include 80 healthy adults between 18 and 40 years of age. Multiple blood draws will occur over the duration of the study. Participants will be involved in study related procedures for approximately 13 months.

NCT ID: NCT00344539 Completed - Clinical trials for Plasmodium Falciparum Malaria

AMA1-C1/Alhydrogel + CpG 7909 for Malaria

Start date: May 2005
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test an experimental malaria vaccine in about 75 healthy adults, 18-45 years of age. The study will also test an experimental adjuvant which is a material added to a vaccine to help the body make more defense cells. The body's immune response (response to foreign substances) and the safety of the vaccine will be tested. All subjects will receive 3 doses of vaccine on days 0, 28, and 56 and doses may increase during the study. Participation in the study is expected to be up to 323 days and includes 16 visits. Study procedures include medical history, physical exams, urine and blood testing.