Reproducibility of Malaria Challenge in Healthy Volunteers
|ClinicalTrials.gov Identifier: NCT01058226|
Recruitment Status : Completed
First Posted : January 28, 2010
Last Update Posted : March 31, 2011
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Biological: Malaria challenge (wild-type NF54 strain Plasmodium falciparum sporozoites)||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Masking:||None (Open Label)|
|Official Title:||Reproducibility of Malaria Challenge in Healthy Volunteers|
|Study Start Date :||February 2010|
|Primary Completion Date :||May 2010|
|Study Completion Date :||September 2010|
Biological: Malaria challenge (wild-type NF54 strain Plasmodium falciparum sporozoites)
- Development of malaria parasitemia and time to parasitemia demonstrated on peripheral blood smear [ Time Frame: Day 5 through Day 28 post challenge ]
- Occurrence of unsolicited AEs [ Time Frame: Day 0 through Day 56 post challenge ]
- Local and systemic solicited adverse events (AEs) [ Time Frame: Day 5 through Day 28 post challenge ]
- Occurrence of serious AEs [ Time Frame: Day 0 through Day 56 post challenge ]
- Cell-mediated immune response to experimental malaria infection [ Time Frame: Day 0 through Day 56 post challenge ]
- Humoral immune responses to experimental malaria infection [ Time Frame: Day 0 through Day 56 post challenge ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01058226
|United States, Washington|
|Seattle Biomedical Research Institue's Malaria Clinical Trial Center|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Angela Talley, M.D.||Seattle Biomedical Research Institute|