Recruiting

Antimalarial Drugs, Vaccines

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT02639299

Conditions

Malaria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Malaria

Study ID

NCT02639299

Start date

Dec 8, 2016

Status verified date

Dec 30, 2025

Completion date

Sep 30, 2030

Anticipated

Primary completion date

Sep 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

  • 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

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy volunteer

healthy, malaria-na(SqrRoot) ve US adults

Primary outcome measure

  • To screen healthy volunteers for future malaria studies [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

888-624-1937

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

Aug 28, 2026

Last verified

Dec 30, 2025

Keywords

  • Subjects
  • Venipuncture
  • Research
  • Evaluate
  • Recruit

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2026-08-28.