Screening of Healthy Volunteers for Investigational Antimalarial Drugs, Malaria Vaccines, and Con… (NCT02639299) | Clinical Trial Compass
RecruitingNot Applicable
Screening of Healthy Volunteers for Investigational Antimalarial Drugs, Malaria Vaccines, and Controlled Human Malaria Challenge
United States1,500 participantsStarted 2016-12-08
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Age \>= 18 and \<= 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)
Exclusion criteria
✕. Pregnant, breastfeeding, or planned pregnancy in the upcoming year.
✕. Hemoglobin, white blood cell (WBC), platelets, alanine transaminase (ALT), and creatinine (Cr) outside of local lab normal range (subjects may be included at the investigator's discretion for "not clinically significant" values outside of normal range).
✕. Anticipated use during the study period, or use within the following periods prior to enrollment:
✕. Investigational malaria vaccine within the last five years
What they're measuring
1
To screen healthy volunteers for future malaria studies
Timeframe: 1 year
Trial details
NCT IDNCT02639299
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)