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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT06607003
Phase
PHASE1
Status
Recruiting
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Conditions

  • Malaria

Eligibility Criteria

Sex
ALL
Age
18 Years - 54 Years
Healthy Volunteers
Accepted

Interventions

  • P. vivax challenge agent derived from PvHMB-CCE001 — BIOLOGICAL
    P. vivax challenge agent derived from PvHMB-CCE001 consists of infected and uninfected erythrocytes stabilized in glycerolyte. Challenge agent derived from this bank consists of thawed, washed, infected and uninfected erythrocytes suspended in injectable-grade normal saline.

Study Details

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.

Key Dates

Start date
Nov 26, 2024
Status verified
May 2026
Primary completion
Nov 26, 2027
Completion
Nov 26, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: P. vivax challenge agent derived from PvHMB-CCE001 Main Arm
    Up to 50 participants will undergo IBSM to further establish safety of the P. vivax challenge agent derived from PvHMB-CCE001 and evaluate transmission to mosquitoes using feeding assays and assess the host response to P. vivax infection.
  • Experimental: P. vivax challenge agent derived from PvHMB-CCE001 Pilot Arm
    2 participants will undergo IBSM to establish the safety and infectivity of the P. vivax challenge agent derived from PvHMB-CCE001.

Primary Outcome Measure

To assess the safety of the P. vivax IBSM model following inoculation of healthy participants. [ Time Frame: Time of inoculation with the challenge agent until at least 21 days after inpatient discharge ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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