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New treatment option for Plasmodium Vivax Infection
Official title A Controlled Human Vivax Malaria Infection Study Through Inoculation of Infected Erythrocytes
ClinicalTrials.gov ID: NCT05071079
What this study is testing
What is An inoculum of malaria parasitised red blood cells with whole dose blood-stage inoculum?
An inoculum of malaria parasitised red blood cells with whole dose blood-stage inoculum is an investigational medicine, given as an once-daily injectable medicine, being studied as a potential treatment for plasmodium vivax infection.
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
- The primary objectives of this study are to assess the safety and feasibility of blood-stage controlled human P. vivax malaria infection (CHMI) in healthy adult Thai volunteers through experimental injection of cryopreserved P.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 55. Healthy volunteers may be eligible.
You may be able to join if
- The volunteer must meet all of the following criteria to be eligible for the study:
- Healthy Thai adult aged 20 to 55 years with weight at least 50 kg.
- Red blood cells positive for the Duffy antigen/chemokine receptor (DARC)
- Women only: Must practice continuous effective contraception for the duration of study period until 3 months post-challenge.
- COVID-19 vaccination at least two doses of COVID-19 vaccines approved by WHO.
You likely can't join if
- The volunteer must NOT enter the study if any of the following apply:
- Positive malaria qPCR OR malaria film
- Presence of any medical condition (either physical or psychological) which in the judgment of the investigator would place the participant at undue...
- Presence of chronic disease or chronically use of medication
- Use of systemic antibiotics with known antimalarial activity in the 30 days before challenge (e.g. trimethoprim-sulfamethoxazole, doxycycline...
- Use of immunoglobulins or blood products (e.g. blood transfusion) at any time in the 1 year preceding enrolment
See the full eligibility criteria
- The volunteer must meet all of the following criteria to be eligible for the study:
- Healthy Thai adult aged 20 to 55 years with weight at least 50 kg.
- Red blood cells positive for the Duffy antigen/chemokine receptor (DARC)
- Women only: Must practice continuous effective contraception for the duration of study period until 3 months post-challenge.
- COVID-19 vaccination at least two doses of COVID-19 vaccines approved by WHO.
- Agreement to refrain from blood donation during the course of the study and for 1 year after the initiation of antimalarial treatment.
- Willing to be admitted in the Hospital for Tropical Diseases for clinical monitoring, until antimalarial treatment is completed and their symptoms are settling.
- Willing to take a curative antimalarial treatment following CHMI.
- Willing to reside in Bangkok and its vicinity for 2 months after malarial treatment initiation.
- Able to read and write in Thai.
- Provide written informed consent to participate in the trial
- Answer all questions on the informed consent quiz correctly
- Educational level: has at least an undergraduate degree
- The volunteer must NOT enter the study if any of the following apply:
- Positive malaria qPCR OR malaria film
- Presence of any medical condition (either physical or psychological) which in the judgment of the investigator would place the participant at undue risk or interfere with the results of the study (e.g. serious...
- Presence of chronic disease or chronically use of medication
- Use of systemic antibiotics with known antimalarial activity in the 30 days before challenge (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones and azithromycin)
- Use of immunoglobulins or blood products (e.g. blood transfusion) at any time in the 1 year preceding enrolment
- Receipt of an investigational product, any vaccine in the 30 days preceding enrolment (D0), or planned receipt during the study period
- Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data or the P. vivax parasite as assessed by the Investigator.
- Any confirmed, or suspected immunosuppressive, or immunodeficient state, including HIV infection, asplenia, history of splenectomy, recurrent, severe infections, and chronic infection
- Immunosuppressant medication within the past 6 months preceding enrolment (D0) (inhaled and topical steroids are allowed)
- History of allergic disease or reactions likely to be exacerbated by malaria infection
- Female participant who is pregnant as evidenced by positive beta-human chorionic gonadotropin (β-HCG) test, lactating, or planning pregnancy during the course of the study
- Contraindications to the use of antimalarial treatment (e.g. chloroquine, atovaquone / proguanil or dihydroartemisinin/piperaquine)
- Use of medications known to have a potentially clinically significant interaction with the antimalarial drug that will be used in this study (chloroquine, atovaquone / proguanil or dihydroartemisinin/piperaquine)
- Known existing positive family history in both 1st AND 2nd degree relatives \< 50 years old for cardiac disease
- History of cardiac arrhythmia, including clinically relevant bradycardia
- Family history of congenital QT prolongation or sudden death
- Any clinical condition, including using medications, known to prolong the QT interval.
- Screening electrocardiogram (ECG) demonstrates a QTc interval ≥ 450 ms.
- Suspected or known or history of alcohol abuse
- Suspected or known or history of drug abuse.
- Concurrently participating in another clinical study, at any time during the study period
- Haemoglobin \< 11 g/dL
- Positive hepatitis B surface antigen or seropositive for hepatitis C virus
- Finding on safety laboratory values as defined below:
- Abnormal AST (AST \> 40 U/L for male, and \> 32 U/L for female [upper normal range])
- Abnormal ALT (ALT \> 41 U/L for male, and \> 33 U/L for female [upper normal range])
- Abnormal serum creatinine (Scr) (Creatinine [Cr] \> 1.17 mg/dL for male, and \> 0.95 mg/dL for female [upper normal range])
- Abnormalities corrected calcium and magnesium blood levels
- Blood group Rhesus negative
- Blood incompatibility to the inoculum
- Positive for COVID-19 diagnosed by RT-PCR
The study team makes the final eligibility decision.
Where it's taking place
- Bangkok, Thailand
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, 20 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bangkok, Thailand. 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.