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 range18 Years – 54 Years
SexALL
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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.
✓. 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).
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)
✕. 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.