Actively Recruiting
Screening of Healthy Volunteers for Investigational Antimalarial Drugs, Malaria Vaccines, and Controlled Human Malaria Challenge
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-24
1500
Participants Needed
1
Research Sites
720 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Screening of Healthy Volunteers for Investigational Antimalarial Drugs, Malaria Vaccines, and Controlled Human Malaria Challenge
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 50 years
- In good general health without significant medical history
- Reliable access to the clinical trial center and availability in the area for more than 1 year
- Females of childbearing potential willing to undergo periodic pregnancy testing and use reliable contraception per protocol when enrolled in LMIV clinical trials
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy within the next year
- Hemoglobin, white blood cell count, platelets, ALT, or creatinine outside local normal ranges unless deemed not clinically significant
- Use of investigational malaria vaccine within the last five years
- Chronic systemic immunosuppressive medications (except certain nasal or topical corticosteroids)
- Recurrent receipt of blood products or immunoglobulins
- History of sickle cell disease, splenectomy or functional asplenia, systemic anaphylaxis, uncontrolled psoriasis or porphyria
- Significant medical conditions or abnormal lab results affecting immune response or safety
- History or known active cardiac disease including heart attack, angina, heart failure, valve disease, cardiomyopathy, pericarditis, stroke, or exertional chest symptoms
- Infection with HIV, hepatitis B, or hepatitis C
- Psychiatric conditions that impair protocol compliance, including recent psychosis or suicide risk
- Suspected or known current alcohol or drug abuse
- Any other condition that interferes with study adherence, safety, or informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
D
David M Cook, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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