Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity … (NCT06607003) | Clinical Trial Compass
RecruitingPhase 1
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
United States300 participantsStarted 2024-11-26
Plain-language summary
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....
Who can participate
Age range
18 Years – 54 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age \>=18 and \<=54 years.
. RBCs positive for Duffy antigen/chemokine receptor.
. Malaria comprehension exam passed prior to study activities.
. Suitable accommodation and reliable access to the NIHCC for the duration of the study in the opinion of the investigator.
. Persons of childbearing potential must be willing to use reliable contraception from 28 days prior to challenge agent administration to the end of study.
. Signing of the informed consent form.
. Agreement to not live alone from challenge agent administration until the completion of antimalarial treatment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the safety of the P. vivax IBSM model following inoculation of healthy participants.
Timeframe: Time of inoculation with the challenge agent until at least 21 days after inpatient discharge
Trial details
NCT IDNCT06607003
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Agreement to long-term storage of study samples for future research.
Exclusion criteria
. Planned travel to a P. vivax-endemic area during the study period (see https://www.cdc.gov/malaria/travelers/country\_table/a.html).
. History of travel to or residence in a P. vivax malaria-endemic region for more than 2 weeks during the past 2 years.
. Prior confirmed P. vivax malaria diagnosis or clinical history consistent with likely P. vivax infection. At the investigator's discretion, participants may be enrolled if the exposure was remote, e.g., \> 5 years ago.
. Poor peripheral venous access, at the discretion of the investigator.
. For persons of childbearing potential:
. Currently pregnant or breastfeeding, or planning on becoming pregnant or breastfeeding until the end of study.
. Rh blood group negative.
. Being a current or former study team member or clinical trial staff with direct involvement of the trial, or being an employee supervised by a study team member.