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Tests treatment safety and results for Malaria
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
ClinicalTrials.gov ID: NCT06607003
What this study is testing
What is P. vivax challenge agent derived from PvHMB-CCE001?
P. vivax challenge agent derived from PvHMB-CCE001 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for malaria.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 54. Healthy volunteers may be eligible.
You may be able to join if
- All of the following criteria must be fulfilled for a participant to undergo IBSM:
- 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.
You likely can't join if
- A participant will be excluded from participating in this trial if any 1 of the following criteria is fulfilled:
- 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...
- Poor peripheral venous access, at the discretion of the investigator.
- For persons of childbearing potential:
See the full eligibility criteria
- All of the following criteria must be fulfilled for a participant to undergo IBSM:
- 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.
- A participant will be excluded from participating in this trial if any 1 of the following criteria is fulfilled:
- 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.
- Unwillingness to defer blood donations for at least 3 years.
- Use of any of the following within the specified periods:
- Investigational P. vivax vaccine within the last 2 years.
- Malaria chemoprophylaxis within 3 months of Day 0.
- Chronic systemic immunosuppressive medications (\>14 days) within 6 months (e.g., cytotoxic medications, adrenocorticotrophic hormone, or oral/parental corticosteroids equivalent to \>0.5 mg/kg/day of prednisone)...
- Prior receipt of packed red cells or other blood products or immunoglobulins within the previous 6 months.
- Systemic antibiotics or medications with potential antimalarial effects less than 28 days before Day 0 (e.g., clindamycin, chloroquine, benzodiazepines, tetracycline, azithromycin, or doxycycline).
- Investigational product or vaccine less than 28 days before Day 0.
- Receipt of any vaccination less than 28 days before Day 0.
- Current or planned use of medications known to significantly prolong the QT interval or otherwise interfere with study agents.
- Smoking more than 5 cigarettes or equivalent per day and unable to stop smoking for the duration of admission. Participants may smoke up to 5 cigarettes or equivalent per day for the rest of the study (by attestation).
- History of alcohol use disorder (exceptions may be made at the investigator's discretion if they have completed treatment or are otherwise currently abstinent) or refusal to agree to refrain from drinking from the day...
- Clinically significant medical condition, physical examination findings, other clinically significant abnormal laboratory results, or past medical history including:
- Immunodeficiency including asplenia or functional asplenia or significant autoimmune disease.
- Retinal disease, visual field changes, psoriasis, porphyria, or known allergy to chloroquine or artemether/lumefantrine.
- Cardiac disease including \>10% cardiovascular risk as determined by the non-laboratory method or an abnormal EKG demonstrating a corrected QT interval by Fridericia's formula of \>450 msec or other concerning...
- Any other medical condition that may have significant implications for current health status and participation in the study, in the opinion of the investigator.
- History of a severe reaction to arthropod bites, or history of anaphylaxis or severe unexpected allergy to any substance.
- Screening blood test or urinalysis laboratory parameters outside of local lab normal range (including infectious serologies). Participants may be included at the investigator's discretion for "not clinically...
- 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 participant's ability to give...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 54 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.