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PLASMODIUM FALCIPARUM MALARIA clinical trials

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NCT ID: NCT00343005 Completed - Clinical trials for Plasmodium Falciparum Malaria

Experimental Vaccine for Malaria in Adults in Mali

Start date: April 23, 2004
Phase: Phase 1
Study type: Interventional

This study will determine the highest dose of an experimental vaccine called AMA1-C1 that can safely be given to adults exposed to malaria. Malaria affects about 300 million to 500 million people worldwide each year, causing from 2 million to 3 million deaths, mostly among children under 5 years of age in sub-Saharan Africa. It is the leading cause of death and illness among the general population of Mali in West Africa. Increasing drug resistance to the malaria parasite, as well as widespread resistance of mosquitoes (the insects that transmit the parasite) to pesticides are reducing the ability to control malaria through these strategies. A vaccine that could reduce illness and death from malaria would be a valuable new resource in the fight against this disease. AMA1-C1 is an experimental vaccine developed by the NIAID. Early tests of AMA1-C1 in 30 healthy people in the United States found no serious harmful side effects of the vaccine. This study will look at the effect of AMA1-C1 in people in Mali who have been exposed to malaria. Residents of Don gu bougou, Mali, who are between 18 and 45 years of age and are in general good health may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, and urine pregnancy test for women. Participants are randomly assigned to receive three injections (shots) of either the experimental malaria vaccine or a hepatitis B vaccine that is approved and used in Mali. All shots are given in an upper arm muscle. After the first shot, the second is given 1 month later, and the third is given 12 months after the first. Subjects receiving AMA1-C1 will get one of three different doses - low, medium, or high - to find the dose that is safest and gives the best antibody response to the vaccine. After each shot, participants remain in the clinic for 30 minutes for observation. They return to the clinic 1, 2, 3, 7, and 14 days after each shot for a physical examination and to check for side effects. Blood samples are drawn before each shot and at selected return clinic visits to check for side effects and to measure the effect of the vaccine. During the rainy seasons after the second and third vaccinations, subjects come to the clinic once a month for an examination and a blood test. During the dry season, subjects come to the clinic 3 months before the last shot is given for an examination and blood test. Additional blood tests may be done on participants who develop malaria. If found to be safe in adults, further studies with this vaccine will be done in children exposed to malaria, as it is children who bear the brunt of this disease.

NCT ID: NCT00340431 Completed - Clinical trials for Plasmodium Falciparum Malaria

Experimental Vaccine for Plasmodium Falciparum Malaria

Start date: June 9, 2004
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety of two experimental malaria vaccines in healthy volunteers and examine their immune response to them. Safety will be assessed by comparing vaccine side effects in groups of volunteers who receive increasing doses of the same vaccine (dose-escalating study). Immune response will be evaluated by comparing the levels of antibody production with each dose. (Antibodies are infection-fighting proteins produced by the immune system.) The two vaccines in this study contain different types of a malaria protein called MSP1: one type is MSP142FVO and the other is MSP1423D7. Malaria parasites are spread from person to person by mosquitoes. There are four types of malaria parasites. The vaccine tested in this study is designed to work against Plasmodium falciparum, the parasite responsible for most deaths in children due to malaria in sub-Saharan Africa. The vaccine stimulates the body to produce antibodies that prevent P. falciparum from entering the person's red blood cells. Healthy normal volunteers between 18 and 50 years of age may be eligible for this 12-month study, conducted at Quintiles Phase 1 Services in Lenexa, Kansas. Candidates are screened with a medical history, physical examination, and blood and urine tests. Participants receive three doses of the vaccine-on the first day of the study (day 0), at 1 month (day 28), and at 6 months (day 180) -through injection into an arm muscle. The first group of subjects receives 5 micrograms of vaccine, the second group receives 20 micrograms, and the third group receives 80 micrograms. All participants are observed in the clinic for 30 minutes after each immunization for immediate reactions to the vaccine and keep a record of their temperature and of any reactions and side effects they experience for 6 days after the vaccination. At various intervals throughout the study, participants undergo a brief physical examination and blood tests. Women of childbearing potential have a urine pregnancy test on the day of each injection.

NCT ID: NCT00338520 Completed - Clinical trials for Plasmodium Falciparum Malaria

Hyperphenylalaninemia in Cerebral Malaria

Start date: October 2007
Phase: N/A
Study type: Observational

The purpose of this study is to see if children, who develop coma from malaria, are not making enough of a vitamin-like chemical, tetrahydrobiopterin (BH4), which is required for the brain to function normally. This information may help to identify new ways to treat malaria in the future. Study participants will include 512 children, ages 6 months to 6 years. Participants will be placed into one of 4 groups: well children; children with mild malaria; children without malaria, but with a medical problem involving the brain that requires a lumbar puncture for diagnosis (a procedure in which a needle is placed into an area surrounding the spinal cord and a sample of cerebral spinal fluid is removed); and children with a severe form of malaria affecting the brain called cerebral malaria. Study procedures will include blood samples, urine samples and lumbar puncture, only if necessary for diagnosis as part of standard practice procedures. Participants will be involved in study related procedures for up to 3 weeks.

NCT ID: NCT00322816 Completed - Clinical trials for Plasmodium Falciparum Malaria

Malaria Prevalence in Children

Start date: June 7, 2006
Phase:
Study type: Observational

The purpose of this pilot study is to evaluate the use of (1) 'malaria prevalence', (2) 'malaria incidence' and (3) 'malaria mortality' as a measure of malaria transmission in The Gambia, while mosquito insecticides (larvicides) are used to control malaria-carrying mosquitoes. Two thousand children aged 6 months to 10 years of age will be recruited from villages in the study area. They will be monitored over 7 months for the presence of malaria parasites and signs and symptoms of the disease.

NCT ID: NCT00322738 Completed - Clinical trials for Plasmodium Falciparum Malaria

Time to Infection With Malaria Parasites

Start date: June 7, 2006
Phase:
Study type: Observational

This study will attempt to find out what effect mosquito insecticides have on the transmission of malaria in The Gambia. Eight hundred healthy men and women, aged 18 to 40 years, living in selected villages east of Farafenni town in The Gambia, West Africa will be screened for parasites. About 552 of these people are expected to be free of malaria and will form the study group. These people will participate in the study for 7 months and will be checked for the malaria-causing parasite every two weeks by finger prick blood sample.

NCT ID: NCT00317473 Completed - Clinical trials for Plasmodium Falciparum Malaria

Phase 1 Trial of a Malaria Vaccine in Young Kenyan Children

Start date: June 2003
Phase: Phase 1
Study type: Interventional

To assess the safety and reactogenicity of the FMP-1/AS02A malaria vaccine in malaria-exposed children living in western Kenya and aged 12-47 months

NCT ID: NCT00314899 Completed - Clinical trials for Plasmodium Falciparum Malaria

Fetal Immunity to Falciparum Malaria

Start date: September 15, 2006
Phase:
Study type: Observational

The purpose of this study is to find out what effect malaria in the mother has on the development of her child's immune system response to malaria and whether being exposed to malaria in the womb makes a child more likely to get malaria. The study will also assess the effect that exposure to malaria in the womb has on the child's growth and development over the first three years of life. Study participants will include 480 healthy pregnant women (greater than or equal to 15 years of age), their healthy offspring, 20 healthy people from the United States with no malaria exposure or disease and 40 adult Kenyans who have previously been exposed to malaria or have malaria with no signs of infection. Study procedures will include an ultrasound (procedure to assess the baby's growth and development in the womb), blood, urine, and stool collections. Newborns will be examined at birth, and at 6, 12, 18, 24, 30 and 36 months of age.

NCT ID: NCT00312702 Completed - Malaria Clinical Trials

Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of America

Start date: April 2006
Phase: Phase 1/Phase 2
Study type: Interventional

Phase I/II Trial of a Malaria Vaccine, FMP011/AS01B, in Adults Living in the United States of America.

NCT ID: NCT00312663 Completed - Clinical trials for Plasmodium Falciparum Malaria

Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of America

Start date: April 2006
Phase: Phase 1/Phase 2
Study type: Interventional

Phase I/II Trial of a Malaria Vaccine, FMP011/AS01B, in Adults Living in the United States of America.

NCT ID: NCT00299208 Completed - Clinical trials for Plasmodium Falciparum Malaria

Azithromycin Combination Therapy for Malaria

Start date: n/a
Phase: Phase 2
Study type: Interventional

The goal of this study is to develop a safe, well tolerated, and highly efficacious azithromycin combination treatment for uncomplicated falciparum malaria. Azithromycin is a drug that has shown potential for malaria treatment. It will be combined with other malaria drugs currently approved for treatment in Thailand. About 120 people, ages 20-65, will be enrolled in Thailand. Participants will have severe cases of malaria and they will be hospitalized 28 days for treatment.