This is a prospective, single arm, single intervention safety and immunogenicity study in 6 healthy, malaria-naive adults, conducted to demonstrate the successful implementation of the well-established malaria challenge model at the Seattle Biomedical Research Institute (Seattle BioMed).
This study is designed to demonstrate the ability to inoculate malaria naive human volunteers with the Plasmodium falciparum strain of malaria sporozoites by the bite of infected mosquitoes under controlled conditions. Subjects are monitored closely for development of malaria and treated with standard doses of anti-malarial medications which the Plasmodium falciparum strain of malaria is known to be sensitive.
Study participants will undergo malaria sporozoite challenge with wild-type NF54 strain of Plasmodium falciparum sporozoites administered via the bite of five infected Anopheles stephensi mosquitoes under controlled containment conditions.
Participants will be closely monitored for acute reactogenicity and signs and/or symptoms of malaria infection, and from day five post-challenge, will have daily blood films examined for the presence of malaria parasites. Participants who develop malaria infection will be treated with a standard oral regimen of chloroquine, or other FDA-approved anti-malarial drugs, under direct observation. Participants will be treated upon first evidence of microscopic parasitemia or at day 18 if they remain negative. Participants will be housed with study staff in a local hotel for close observation from day 9 post-challenge, until three consecutive blood smears are negative and all symptoms have resolved, then followed weekly for a total of 8 weeks.
Follow-up for safety will be conducted at 4- and 6- months post-challenge.
Endpoint Classification: Safety Study, Masking: Open Label
Healthy
Malaria challenge (wild-type NF54 strain Plasmodium falciparum sporozoites)
Seattle Biomedical Research Institue's Malaria Clinical Trial Center
Seattle
Washington
United States
98109
Active, not recruiting
Seattle Biomedical Research Institute
Published on BioPortfolio: 2014-08-27T03:16:20-0400
Malaria Challenge With NF54 Strain
The purpose of this study is to determine how many infected mosquito bites are required to reliably give volunteers a case of malaria. It is expected that volunteers will develop malaria a...
Comparison of Three Plasmodium Falciparum Isolates in an Experimental Human Malaria Infection
Plasmodium falciparum isolates display a wide genetic diversity with possibly different properties to induce immune responses. These properties could directly influence the ability to indu...
Trial to Assess the Efficacy of Malaria Vaccine PfCS 102
Phase I/IIa double-blind randomized (adjuvant)-controlled trial. 16 volunteers are randomized to receive two doses of either 30 µg of PfCS102 formulated in Montanide ISA 720 (verum) or I...
PfSPZ Challenge in Non-immune Adults in Baltimore, USA
This is a single center, randomized and controlled human study to optimize controlled human malaria infection (CHMI) administered by direct venous inoculation (DVI). 36 healthy adults aged...
A Systems Biology Approach to Malaria Immunity
This is a phase I study that will assess the acquisition of immunity to Pf malaria over the course of 4 sequential Controlled Human Malaria Infections (CHMI) over 3 years, in 10 healthy ad...
Meteorological factors play a crucial role in malaria transmission, but limited evidence is available from China. This study aimed to estimate the weekly associations between meteorological factors an...
Chloroquine was used for malaria treatment until resistant Plasmodium falciparum was identified. Because 4-aminoquinolines with modified side chains, such as AQ-13, are active against resistant parasi...
DSM265 is a selective inhibitor of Plasmodium dihydroorotate dehydrogenase that fully protected against controlled human malarial infection (CHMI) by direct venous inoculation of Plasmodium falciparum...
Analysis of Plasmodium vivax Chloroquine Resistance Transporter (PvCRT) Mutant Isoforms.
Chloroquine (CQ) resistance (CQR) in Plasmodium falciparum malaria is widespread and has limited the use of CQ in many regions of the globe. Malaria caused by the related human parasite P. vivax is as...
Driving mosquito refractoriness to Plasmodium falciparum with engineered symbiotic bacteria.
The huge burden of malaria in developing countries urgently demands the development of novel approaches to fight this deadly disease. Although engineered symbiotic bacteria have been shown to render m...
Plasmodium Falciparum
A species of protozoa that is the causal agent of falciparum malaria (MALARIA, FALCIPARUM). It is most prevalent in the tropics and subtropics.
Plasmodium
A genus of protozoa that comprise the malaria parasites of mammals. Four species infect humans (although occasional infections with primate malarias may occur). These are PLASMODIUM FALCIPARUM; PLASMODIUM MALARIAE; PLASMODIUM OVALE, and PLASMODIUM VIVAX. Species causing infection in vertebrates other than man include: PLASMODIUM BERGHEI; PLASMODIUM CHABAUDI; P. vinckei, and PLASMODIUM YOELII in rodents; P. brasilianum, PLASMODIUM CYNOMOLGI; and PLASMODIUM KNOWLESI in monkeys; and PLASMODIUM GALLINACEUM in chickens.
Malaria, Falciparum
Malaria caused by PLASMODIUM FALCIPARUM. This is the severest form of malaria and is associated with the highest levels of parasites in the blood. This disease is characterized by irregularly recurring febrile paroxysms that in extreme cases occur with acute cerebral, renal, or gastrointestinal manifestations.
Malaria
A protozoan disease caused in humans by four species of the PLASMODIUM genus: PLASMODIUM FALCIPARUM; PLASMODIUM VIVAX; PLASMODIUM OVALE; and PLASMODIUM MALARIAE; and transmitted by the bite of an infected female mosquito of the genus ANOPHELES. Malaria is endemic in parts of Asia, Africa, Central and South America, Oceania, and certain Caribbean islands. It is characterized by extreme exhaustion associated with paroxysms of high FEVER; SWEATING; shaking CHILLS; and ANEMIA. Malaria in ANIMALS is caused by other species of plasmodia.
Malaria, Vivax
Malaria caused by PLASMODIUM VIVAX. This form of malaria is less severe than MALARIA, FALCIPARUM, but there is a higher probability for relapses to occur. Febrile paroxysms often occur every other day.