MalariaNCT02639299
Screening of Healthy Volunteers for Investigational Antimalarial Drugs, Malaria Vaccines, and Controlled Human Malaria Challenge
An observational study of Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2016to 30 Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy volunteers in the Washington, DC region
Who may be able to join
- All of the following criteria must be fulfilled for a subject to participate in this trial:
- 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)
Who cannot join
- A subject will be excluded from participating in this trial if any one of the following criteria is fulfilled:
- 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
- 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.
Show all 31Show fewer
- Recurrent receipt of blood products or immunoglobulins
- History of:
- Sickle cell disease
- Splenectomy or functional asplenia
- Systemic anaphylaxis
- Uncontrolled psoriasis or porphyria
- 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:
- A process that would affect the immune response, or requires medication that affects the immune response.
- Any contraindication to repeated phlebotomy.
- History of or known active cardiac disease including:
- prior myocardial infarction (heart attack)
- angina pectoris
- congestive heart failure
- valvular heart disease
- cardiomyopathy
- pericarditis
- stroke or transient ischemic attack
- exertional chest pain or shortness of breath
- other heart conditions under the care of a doctor
- Infection with HIV, hepatitis B, and/or hepatitis C
- Psychiatric condition that precludes compliance with the protocol including but not limited to:
- Psychosis within the past 3 years
- Ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office, 888-624-1937
About this study
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.
Read more
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.
Read the detailed description
This is a screening protocol for healthy volunteers to participate in research studies conducted by Laboratory of Malaria Immunology and Vaccinology (LMIV).
Malaria-related morbidity and mortality have a major economic impact in endemic regions and
present a substantial health risk to non-immune travelers and people living in endemic areas. To stem the worldwide impact of this devastating disease, a safe and broadly effective malaria vaccine and improved antimalarial therapeutics are urgently required.
This screening protocol is designed to continuously evaluate potential healthy volunteers to build a pool of volunteers who may participate in future and ongoing LMIV malaria drug, vaccine, or controlled human malaria infections (CHMI) trials. A complete medical history and blood and urine samples will be obtained to evaluate whether volunteers are eligible for study-specific screening.
- Conditions
- Malaria
- Keywords
- Subjects, Venipuncture, Research, Evaluate, Recruit
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteer | healthy, malaria-na(SqrRoot) ve US adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
To screen healthy volunteers for future malaria studies
identify healthy adults at a low risk of developing complications due to experimental malaria infection, investigational antimalarials and vaccines
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2015 (estimated)
- Study start8 Dec 2016
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- David M Cook, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639299
- Sponsor's protocol ID
- 160039
- Other IDs
- 16-I-0039
- Status last verified
- 30 Dec 2025
- First submitted
- 23 Dec 2015
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a screening protocol for healthy volunteers to participate in research studies conducted by Laboratory of Malaria Immunology and Vaccinology (LMIV).@@@@@@@@@@@@This screening protocol is designed to evaluate potential healthy volunteers to build a pool of volunteers who may participate in future and ongoing LMIV malaria drug, vaccine, or controlled human malaria infections (CHMI) trials. Data obtained for individual subjects will used not be used for direct research purposes on this study; therefore we will not make IPD available at this time.
Publications
YOELI M. STUDIES ON PLASMODIUM BERGHEI IN NATURE AND UNDER EXPERIMENTAL CONDITIONS. Trans R Soc Trop Med Hyg. 1965 May;59:255-76. doi: 10.1016/0035-9203(65)90004-0. No abstract available.
PubMed 14298028
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Healthy Volunteers for Investigational Antimalarial Drugs, Malaria Vaccines, and Controlled Human Malaria Challenge
- ClinicalTrials.gov ID
- NCT02639299
- Acronym / sponsor ID
- 160039
- Conditions
- Malaria
- Keywords
- Subjects, Venipuncture, Research, Evaluate, Recruit
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 8 Dec 2016 (actual)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 24 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a screening protocol for healthy volunteers to participate in research studies conducted by Laboratory of Malaria Immunology and Vaccinology (LMIV).
Malaria-related morbidity and mortality have a major economic impact in endemic regions and
present a substantial health risk to non-immune travelers and people living in endemic areas. To stem the worldwide impact of this devastating disease, a safe and broadly effective malaria vaccine and improved antimalarial therapeutics are urgently required.
This screening protocol is designed to continuously evaluate potential healthy volunteers to build a pool of volunteers who may participate in future and ongoing LMIV malaria drug, vaccine, or controlled human malaria infections (CHMI) trials. A complete medical history and blood and urine samples will be obtained to evaluate whether volunteers are eligible for study-specific screening.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteer | – | –healthy, malaria-na(SqrRoot) ve US adults |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy volunteers in the Washington, DC region
Key inclusion criteria (5 listed)
- All of the following criteria must be fulfilled for a subject to participate in this trial:
- 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)
Key exclusion criteria (31 listed)
- A subject will be excluded from participating in this trial if any one of the following criteria is fulfilled:
- 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:
- History of:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To screen healthy volunteers for future malaria studies
Time frame: 1 year
identify healthy adults at a low risk of developing complications due to experimental malaria infection, investigational antimalarials and vaccines
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Background: PubMed 14298028YOELI M. STUDIES ON PLASMODIUM BERGHEI IN NATURE AND UNDER EXPERIMENTAL CONDITIONS. Trans R Soc Trop Med Hyg. 1965 May;59:255-76. doi: 10.1016/0035-9203(65)90004-0. No abstract available.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. This is a screening protocol for healthy volunteers to participate in research studies conducted by Laboratory of Malaria Immunology and Vaccinology (LMIV).@@@@@@@@@@@@This screening protocol is designed to evaluate potential healthy volunteers to build a pool of volunteers who may participate in future and ongoing LMIV malaria drug, vaccine, or controlled human malaria infections (CHMI) trials. Data obtained for individual subjects will used not be used for direct research purposes on this study; therefore we will not make IPD available at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David M Cook, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David M Cook, M.D. ((240) 627-3066, cookdm@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To screen healthy volunteers for future malaria studies (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02639299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.