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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
31
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.
No Intervention
Walter Reed Army Institute of Research
Silver Spring, Maryland, United States
Subjects showing four-fold increase in antibody titer
The focus of the statistical analysis will be to estimate (with 95% confidence limits) the sensitivity of Pf assay in the mefloquine and control arms. Sensitivity will be calculated as the number of subjects in each cohort who develop at least a four-fold increase in antibody titer from baseline (measured positives) divided by the number infected (true positives). The binomial test will used to test the null hypothesis that the sensitivity in the mefloquine arm is at 30% α(= 0.05; one-sided). The control group will serve as a check on the challenge. The study is not powered to statistically test for a difference in sensitivity between mefloquine and control arms. ELISA titer data will be log-transformed for all analyses. For each group, geometric mean anti-MSP-1 antibody titers with 95% confidence intervals will be determined by ELISA and tabulated at each time point which blood samples are taken for serology.
Time frame: 1 year
Subjects showing Anti- Pf MSP-1 IgG antibody response
The focus of the statistical analysis will be to characterize the antibody kinetics in subjects over that time, will be presented graphically in whole blood concentration vs. time plots. We will identify individual Cmax, t 1/2, and time to Cmax as well determined point estimates and confidence intervals for the cohorts. We will also estimate the percentage cross-reactivity of the serum in each cohort by measuring the number of subjects who test Pf assay positive divided by the number of subjects Pf infected with in each cohort.
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.