NCT00761020

Merozoite Surface Protein 1 Antibody Response in Asymptomatic Human Malaria Infection

Analysis of Anti-Plasmodium Falciparum Merozoite Surface Protein 1 Antigen Specific Antibodies in a Human Malaria Challenge Using Mefloquine Prophylaxis to Confirm Assay Sensitivity and Establish Key Antibody Kinetic Parameters

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this trial is to study whether a certain blood test can reliably identify the presence of malaria in people who have been infected with, but who do not have symptoms of malaria.

Detailed description

In this study, two groups of volunteers will be exposed to malaria through the bites of infected mosquitoes. In one group, volunteers will be given several doses of a drug called mefloquine, known to prevent the development of malaria symptoms. The other group will not be treated with any drug that could prevent symptoms or infection. After exposure, both groups will be monitored for a period of approximately 6 months to see if they develop symptoms of malaria. Any subjects who do so will be treated with appropriate medications. Subjects in both groups will have their blood checked regularly during this period for the presence of a certain malaria antibody called Merozoite Surface Protein 1, or Anti-MSP-1 for short, using a special blood test (also known as an assay). At the completion of the study, the results of all assays will be analyzed to determine if this test can be used to diagnose malaria infection in persons without symptoms.

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	Mefloquine	To determine the seroconversion rate (sensitivity) to Plasmodium falciparum Merozoite Surface Protein 1 (Pf MSP-1) antigen by ELISA assay in the infectivity control and mefloquine cohorts as part of a larger project to support the qualification of anti-MSP-1 antigen-specific antibody assays as valid surrogate endpoints for malaria infection.
OTHER	Control	No Intervention

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-04-01
• Completion: 2009-12-01
• First posted: 2008-09-26
• Last updated: 2021-04-19

Locations

1 site across 1 country: United States