NCT01058226

Reproducibility of Malaria Challenge in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Seattle Children's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Malaria challenge (wild-type NF54 strain Plasmodium falciparum sporozoites)	Malaria sporozoite challenge with the wild-type NF54 strain of Plasmodium falciparum delivered by the bite of five infected Anopheles stephensi mosquitoes.

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-05-01
• Completion: 2010-09-01
• First posted: 2010-01-28
• Last updated: 2011-03-31

Locations

1 site across 1 country: United States