Healthy volunteers needed to help fight malaria
NCT ID NCT02639299
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 5 times
Summary
This study screens healthy adults aged 18 to 50 to see if they can join future malaria research trials. The goal is to find safe and effective malaria vaccines, drugs, or prevention methods. Participants will have a medical history check, physical exam, and blood and urine tests. No treatment is given in this screening study.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2016
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
healthy volunteers in the Washington, DC region
- Ages
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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: All of the following criteria must be fulfilled for a subject to participate in this trial: 1. Age \>= 18 and \<= 50 years. 2. In good general health and without clinically significant medical history 3. Reliable access to the clinical trial center and available in the area for more than 1 year 4. 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: A subject will be excluded from participating in this trial if any one of the following criteria is fulfilled: 1. Pregnant, breastfeeding, or planned pregnancy in the upcoming year. 2. 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). 3. Anticipated use during the study period, or use within the following periods prior to enrollment: 1. Investigational malaria vaccine within the last five years 2. Chronic systemic immunosuppressive medications (e.g., cytotoxic medications, oral/parental corticosteroids \> 0.5 mg/kg/day prednisone or equivalent). Corticosteroid nasal spray for allergic rhinitis and topical corticosteroids for mild, uncomplicated dermatitis is allowed. 3. Recurrent receipt of blood products or immunoglobulins 4. History of: 1. Sickle cell disease 2. Splenectomy or functional asplenia 3. Systemic anaphylaxis 4. Uncontrolled psoriasis or porphyria 5. Clinically significant medical condition, physical examination findings, other clinically significant abnormal laboratory results, or past medical history that may have clinically significant implications for current health status and participation in the study in the opinion of the Investigator. A clinically significant condition or process includes but is not limited to: 1. A process that would affect the immune response, or requires medication that affects the immune response. 2. Any contraindication to repeated phlebotomy. 6. History of or known active cardiac disease including: 1. prior myocardial infarction (heart attack) 2. angina pectoris 3. congestive heart failure 4. valvular heart disease 5. cardiomyopathy 6. pericarditis 7. stroke or transient ischemic attack 8. exertional chest pain or shortness of breath 9. other heart conditions under the care of a doctor 7. Infection with HIV, hepatitis B, and/or hepatitis C 8. Psychiatric condition that precludes compliance with the protocol including but not limited to: 1. Psychosis within the past 3 years 2. Ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years 9. Suspected or known current alcohol or drug abuse as defined by the American Psychiatric Association in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition at the discretion of the PI 10. Any other finding that, in the judgment of the Investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a subject's ability to give informed consent, or increase the risk of having an adverse outcome from participating in the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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