Prophylactic Antimalarial Activity of DB289 in Volunteers
Prophylactic Activity Against MalariaTo evaluate the prophylactic activity of orally administered DB289 against Plasmodium falciparum in non-immune healthy volunteers who are challenged by the bite of five P. falciparum-infected Anopheles stephensi mosquitoes
Intermittent Treatment With Sulfadoxine-pyrimethamine for Malaria Control in Infants
MalariaAnemiaThe purpose of this study is to assess the effectiveness of Intermittent Preventive Treatment in Infants (IPTi) with Sulfadoxine-Pyrimethamine to reduce the numbers of malaria attacks, episodes of anemia, and the overall morbidity and mortality
ICC-1132 - Candidate Vaccine Against P Falciparum Malaria
Plasmodium Falciparum MalariaThe 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.
Three Alternative Drug Regimens for Malaria Seasonal Preventive Treatment in Senegal
MalariaThe purpose of this trial is to compare the acceptability, efficacy and safety of three alternative drug regimens for use for seasonal Intermittent Preventive Treatment to prevent malaria in children. Children aged 2 months to 5 years will be randomized to receive IPT with one of three regimens during the transmission season: sulfadoxine-pyrimethamine (SP) plus amodiaquine, show to be highly effective for IPT in a recent trial; SP plus piperaquine, used for malaria prophylaxis in China for many years; or Duocotexcin (a combination of piperaquine with an artemisinin).
Effectiveness and Cost-Effectiveness of a Rapid Diagnostic Test for Malaria
MalariaThere is increasing evidence from African countries, including Burkina Faso, that at least in some settings/seasons the proportion of fevers attributable to malaria is low or very low: this means that the current strategy of treating all fever cases as malaria is only to the advantage of very few. Rapid, antigenic tests might be of help, particularly in peripheral health centres such as the "Centres de Santé et Promotion Sociale" (CSPS) that lack any laboratory facilities. Nevertheless two major problems could arise: False negatives: as only the negative result would change the decision to treat, versus the current "presumptive" strategy, false negatives would not be treated for malaria. False positives: they would be exposed to the risk to be left without treatment for the true cause of their fever instead. The main purpose of this study is to assess if the short term outcome of febrile patients treated after testing with the Rapid Diagnostic Test Paracheck® is at least equivalent (not inferior) to that of controls (presumptively treated without any test) in terms of clearance of fever and other major symptoms and signs. To do so, febrile patients will be randomly assigned to be submitted to the test before clinical decision, or to be managed the usual way with no test. A follow up will be carried out at Day 4th in order to determine the proportion of patients in both groups with persistence of fever and other main clinical symptoms.
Long-Term Follow-up of Children for a 2-Year Period to Confirm the Safety and Immunogenicity of...
MalariaThe RTS,S/AS02A vaccine (or GSK 257049 vaccine), GSK Biologicals' candidate Plasmodium falciparum (P. falciparum) malaria vaccine is being developed for the routine immunization of infants and children living in malaria endemic areas. The vaccine would offer protection against malaria disease due to the parasite P. falciparum. The vaccine would also provide protection against infection with hepatitis B virus (HBV). This phase IIb trial is being carried out following the demonstration of efficacy of the candidate malaria vaccine in children in Mozambique: there, the vaccine demonstrated approximately 30% efficacy against clinical episodes of malaria and approximately 58% efficacy against severe malaria disease. In this study, the children from Mozambique (NCT= NCT00197041) are followed-up to assess the safety, immunogenicity and efficacy of the candidate malaria vaccine for a two year period commencing 21 months after Dose 1. This protocol posting deals with objectives & outcome measures of the extension phase at year 2. During this extension study, no new subjects will be recruited and no vaccine will be administered. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Phase II AMA-1 Malaria Vaccine FMP2.1/AS02A Trial in Mali
Plasmodium Falciparum MalariaMalaria 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.
Intermittent Preventive Treatment With Antimalarials in Kenyan Infants
MalariaAnemiaThe purpose of the study is to see whether antimalarial drugs administered at the time of routine infant vaccinations prevents malaria and anemia in the first year of life.
Safety and Efficacy Study of RTS,S AS02A/AS01B Vaccine to Prevent Malaria
MalariaThis is a double blinded study where 2 test vaccines will be evaluated to see if they protect persons who have never had malaria against malaria infection when bitten by mosquitoes.
Evaluation of Combined Use of ITN's and Insect Repellents Against Malaria
MalariaInsecticide Treated Nets (ITN's) offer good protection against malaria in Africa where the vector mosquitoes feed indoors late at night. However, in other parts of the world like South America, vectors feed earlier in the evening before people go to bed. In such cases it may be necessary to use alternative treatments in the evening to supplement the efficacy of ITN's. This study compares 2 matched groups of households in the Bolivian Amazon. One group will be given ITN's plus a plant-based insect repellent in the evening, the other has ITN's plus a placebo lotion. Households are monitored over a full malaria season to record numbers of malaria cases.