Active clinical trials for "Malaria"

The aim of the study is to determine the tolerability and safety of ATV-PG + AQ, ATV-PG + AQ placebo, ATV-PG placebo + AQ, and ATV-PG placebo + AQ placebo administered once daily for 3 days to healthy adult male and female subjects.This study in healthy adults is the first step towards establishing the tolerability and safety of the approved doses of ATV-PG and AQ when co-administered. If considered acceptable based on the findings of this study, the tolerability, safety and PE will subsequently be assessed, within the target geographical areas.

An open label, partially blinded clinical trial in which healthy volunteers will be administered experimental malaria vaccines. There will be seven experimental groups of volunteers, of which five receive vaccination with the novel malaria vaccine candidate, R21, in combination with the vaccine adjuvant, Matrix M. The study will assess the safety & immune responses to vaccination, and the efficacy of the vaccine.

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).

This study aims to test directly by means of a cluster randomized controlled trial, the impact of the introduction of RDTs for malaria on dispensing behaviour of chemical sellers, the main non-formal outlet for drugs locally, at community level.

P27A study is designed as a randomized phase Ia/Ib trial to evaluate the safety and immunogenicity of the blood stage candidate vaccine P27A against P. falciparum - P27A antigen and associated adjuvant (Alhydrogel or GLA-SE) - in malaria non exposed European volunteers(Switzerland; phase Ia) and malaria exposed African volunteers (Tanzania; phase Ib).

In areas of Africa where malaria is only a problem during a short rainy season, monthly courses of antimalarial drugs can provide very effective prevention of malaria in children. This approach, called intermittent preventive treatment in children (IPTc) but now known as Seasonal Malaria Chemoprevention (SMC), may also be useful in large areas of Africa where malaria is transmitted for longer each year. It is uncertain if IPTc would be effective, acceptable to communities or sustainable when delivered over a longer period, but this is an important public health question of key interest to policy makers, because in areas with a longer transmission season, the burden of malaria is typically higher than in highly seasonal areas. Another form of prevention that would be operationally easier for African countries to put into practice would be to treat malaria patients with long-lasting antimalarials, which protect children against further malaria episodes for several weeks. Because malaria disproportionately affects certain high risk children more than others, causing repeated attacks of fever and leading to severe anaemia, long-acting drugs may be a simple and effective way to target limited resources at the individuals who most need protection. This may be particularly beneficial where malaria is a seasonal problem, because repeated malaria attacks will not only be borne by a few unfortunate children, but will also occur close together in time. The investigators propose a clinical trial to evaluate these two forms of chemoprevention in Kumasi, Ghana, an area with an extended malaria transmission season. Children under 5 years of age currently have access to diagnosis and treatment of malaria via by community based health workers. Children enrolled in the study will receive either the standard community-based diagnosis and treatment, treatment with a longer-acting artemisinin combination therapy (ACT), or standard care plus five monthly courses of seasonal malaria chemoprevention (SMC) during the peak in transmission.

The purpose of this study is to show the consistency of different lots of a candidate vaccine (257049) against malaria developed by GlaxoSmithKline (GSK) Biologicals.

Hypothesis: The MSP3-LSP/Alum vaccine, administered to children will have a protective efficacy of at least 30% (lower bound of confidence interval of 0) against malaria disease occurring during a period beginning from 14 days after the 3rd immunization until 1 year after. The primary objective of this double-blind, randomized, controlled trial will be to assess the clinical efficacy of MSP3-LSP/AlOH vaccine when administered by subcutaneous route in children aged 12-48 months against all clinical malaria episodes occurring during a period beginning from 14 days after the 3rd immunization until 3 months after 3rd immunization, when administered according to the following schedule:- Primary administration: Three doses of administered 4 weeks apart Secondary administration (Boost): One dose 3 months after the third dose in year 1 of the trial; and two doses, given exactly one year after the date corresponding to the third dose and the first boost given during Year 1 Case definition for an episode of malaria is a febrile illness with axillary temperature of ≥ 37.5ºC with P. falciparum parasitemia ≥ 5000 per μL

Malaria prophylaxis is recommended for sickle cell disease patients. In Nigeria, daily proguanil or weekly pyrimethamine are the most commonly prescribed regimens, but the current policy is not effective due to poor compliance and drug resistance. Intermittent treatment with a long acting drug regimen administered under supervision at clinic visits may be more effective. The aim of this trial is to compare the tolerability and acceptability of supervised bimonthly treatment with either sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ) or mefloquine plus artesunate (MQ+AS), with the daily proguanil. Two hundred and seventy patients with sickle cell disease attending the paediatric sickle cell disease clinic in Ilorin hospital who meet the eligibility criteria and have parental consent, will be randomized to one of three prophylactic regimens: daily proguanil, bimonthly sulfadoxine-pyrimethamine plus amodiaquine, or bimonthly mefloquine plus artesunate. Patients will be asked to return to clinic every two months and whenever they are sick. At enrollment, the study paediatrician will conduct a physical examination of the child, and collect a venous blood sample for a complete blood cell count and biochemical screen, determination of G6PD genotype, preparation of blood smears for malaria microscopy and a blood spot for determination of molecular markers of resistance. Four days after each clinic visit, patients will be interviewed (by phone and, for a subset, at home or in the clinic) to ask about compliance and adverse events. Participants will be followed for one year. The parents or carer will be encouraged to bring their child to the Outpatient Department clinic if the child becomes unwell. The primary outcome of the trial is tolerability, secondary outcomes are adherence to the regimen, and incidence of malaria and the number of hospitalizations over 12 months. If the bimonthly regimens are well tolerated and the preliminary data from this study are promising, a larger multicentre trial will be required to determine efficacy.

The study is designed to establish the best dose to safely infect healthy individuals with Plasmodium falciparum sporozoites (PfSPZ) by injection. The goal of this study is to achieve infections in human volunteers with infection rates of 100% and pre-patent periods of less than 12 days.