Screening of Healthy Volunteers for Investigational Antimalarial Drugs, Malaria Vaccines, and Controlled Human Malaria Challenge

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Background: Malaria is a serious infection caused by a parasite. People get malaria when an infected mosquito bites them. Malaria can cause major health and social problems in places were malaria is common, such as Africa but can also affect travelers who have never been exposed to malaria. Researchers at the NIH want to find a safe and effective malaria vaccine, antimalarial drugs, or prevention regimen. To do this, healthy volunteers are recruited under a general screening study in order to see if are qualified to join a future malaria study.

Objective: To screen healthy volunteers to see if they are eligible to join investigational malaria studies. The studies will be trials of investigational antimalarial drugs, malaria vaccines, or prevention regimens. They may also involve controlled human malaria infection trials.

Eligibility: Healthy people ages 18 50

Design: Participants will first be prescreened by phone. Participants will be screened with: Medical history Physical exam Blood and urine tests Participants may go more than 1 year without joining a clinical trial. If this happens, they may be re-contacted to see if they still want to be part of this screening protocol. Those who still want to participate and have had relevant medical changes will be rescreened.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
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⁃ All of the following criteria must be fulfilled for a subject to participate in this trial:

• Age greater than or equal to 18 and less than or equal to 50 years.

• In good general health and without clinically significant medical history

• Reliable access to the clinical trial center and available in the area for more than 1 year

• Females of childbearing potential must be willing to undergo periodic pregnancy testing and use reliable contraception per protocol when enrolled into LMIV clinical trials (protocol-specific requirements)

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
David M Cook, M.D.
cookdm@mail.nih.gov
(240) 627-3066
Time Frame
Start Date: 2016-12-08
Estimated Completion Date: 2030-09-30
Participants
Target number of participants: 1500
Treatments
Healthy volunteer
healthy, malaria-na(SqrRoot) ve US adults
Authors
Agnes N Mwakingwe, Sara A Healy
Related Therapeutic Areas
Sponsors
Leads: National Institute of Allergy and Infectious Diseases (NIAID)

This content was sourced from clinicaltrials.gov