Actively Recruiting
Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Challenge Agent and Evaluate Transmission in Mosquito Feeding Assays
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-28
300
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Malaria is a disease caused by parasites transmitted to people by mosquitoes. Around the world, there were 241 million cases and 627,000 deaths from malaria in 2020. Researchers are working to develop vaccines and treatments for this disease. Objective: To learn how malaria develops in people; how the body's immune system reacts to malaria; and how malaria spreads from people to mosquitoes. Eligibility: Healthy people in the Washington DC area, aged 18 to 54 years. They cannot live alone during parts of the study. Design: Participants will be infected with a parasite that causes malaria. The parasite will be in donated blood; it will be given through an IV. Participants will likely develop symptoms within a week after the injection. Researchers will call daily to check on their health. After about 6 days, participants will come to the NIH clinic each day for blood tests. Participants will check in to the NIH clinic around 10 days after the injection. They will stay in the clinic 3 to 6 days. They will have multiple blood tests every day. Participants will be bitten by mosquitoes up to 4 times. Cups containing mosquitoes will be held against their skin for 15 minutes. Participants will begin taking chloroquine close to the end of their clinic stay. Chloroquine is a pill taken by mouth once or twice a day for 3 days. It is FDA-approved to treat malaria. Participants will have follow-up visits 1 and 3 weeks after discharge.
CONDITIONS
Official Title
Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Challenge Agent and Evaluate Transmission in Mosquito Feeding Assays
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 54 years
- Positive for Duffy antigen/chemokine receptor on red blood cells
- Passed a malaria comprehension exam before starting the study
- Have suitable accommodation and reliable access to the NIH Clinical Center throughout the study
- Willing to use reliable contraception from 28 days before infection until the study ends if able to have children
- Signed informed consent form
- Agree not to live alone from the time of infection until finishing antimalarial treatment
- Agree to long-term storage of study samples for future research
You will not qualify if you...
- Planned travel to a P. vivax malaria-endemic area during the study
- Travel to or residence in a P. vivax malaria-endemic region for more than 2 weeks in the past 2 years
- Prior confirmed or likely P. vivax malaria infection unless exposure was over 5 years ago
- Poor peripheral venous access
- Currently pregnant, breastfeeding, or planning pregnancy until study end
- Rh blood group negative
- Current or former study team member or staff involved in this trial
- Unwilling to defer blood donations for at least 3 years
- Use of investigational P. vivax vaccine within 2 years
- Malaria chemoprophylaxis within 3 months before study start
- Use of systemic immunosuppressive medications over 14 days within 6 months
- Prior blood transfusions or immunoglobulin use within 6 months
- Use of systemic antibiotics or antimalarial medications within 28 days before study
- Receipt of any vaccination within 28 days before study
- Use of medications affecting QT interval or interfering with study agents
- Smoking more than 5 cigarettes per day and unable to stop during admission
- History of alcohol use disorder or refusal to abstain from alcohol during study
- Significant medical conditions including immunodeficiency, autoimmune disease, retinal disease, psoriasis, porphyria, allergy to study drugs, or cardiac disease
- History of severe reaction to insect bites or severe allergies
- Abnormal screening blood or urine tests outside normal limits unless not clinically significant
- Any condition that could interfere with study participation, safety, or informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
J
Joel A Goldberg, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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