Status:
UNKNOWN
In-vivo Transmission Model in Semi-immune Adults
Lead Sponsor:
Ifakara Health Institute
Collaborating Sponsors:
University of Oxford
Conditions:
Controlled Human Malaria Infection
Induced Blood Stage Malaria Infection
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
Controlled human malaria infection (CHMI) has revolutionized the development of malaria vaccines. It involves the administration of either known numbers of sporozoites or infected erythrocytes to heal...
Detailed Description
Adaptation of blood-stage Controlled Human Malaria Infection for evaluation of transmission blocking malaria interventions in malaria endemic countries. This will be Phase I Randomized open label tri...
Eligibility Criteria
Inclusion
- Male volunteers aged 18-45 years and in good health.
- Volunteer has adequate understanding of the procedures of the study and is able and willing (in the investigator's opinion) to comply with all study requirements.
- Participant is willing and able to give informed consent for participation in the trial.
- Participant with low malaria exposure as determined by anti-schizont ELISA
- Literacy in Kiswahili.
- Anti-schizont antibody levels below 50th centile of the most recently available population anti-schizont in Bagamoyo district
Exclusion
- Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, such as cardiovascular, pulmonary, gastrointestinal, renal, hepatic, neurological, dermatological (e.g. psoriasis, contact dermatitis etc.), allergy, endocrine, malignant, haematological, infectious, immunodeficient, psychiatric and other disorders, which could compromise the health of the volunteer during the study or interfere with the interpretation of the study results.
- A heightened risk of cardiovascular disease, as determined by: an estimated ten-year risk of fatal cardiovascular disease of ≥5% at screening, as determined by the Systematic Coronary Risk Evaluation (SCORE); history, or evidence at screening, of clinically significant arrhythmia, prolonged QT-interval or other clinically relevant ECG abnormalities; or a positive family history of cardiac events in 1st or 2nd degree relatives \<50 years old.
- Body mass index (BMI) of \<18 or \>30 Kg/m2
- A medical history of functional asplenia
- Female volunteers
- Confirmed parasite positive by PCR a day before challenge i.e., at C-1.
- Screening tests positive for Human Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV), Hepatitis C Virus (HCV)
- Chronic use (\>30 days) of i) immunosuppressive drugs, ii) antibiotics, iii) or other immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral antihistamines exempted) or expected use of such during the study period
- Any recent (within 30 days) or current systemic therapy with an antibiotic or drug with potential antimalarial activity (chloroquine, doxycycline, tetracycline, piperaquine, benzodiazepine, flunarizine, fluoxetine, tetracycline, azithromycin, clindamycin, erythromycin, hydroxychloroquine, etc.) (Allowable time frame for use at the Investigator'sdiscretion).
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years.
- Any history of treatment for severe psychiatric disease by a psychiatrist in the past year.
- History of drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset.
- Previous participation in any malaria investigational product study (allowable time frame for use at the Investigator's discretion)
- Participation in any other clinical study in the 30 days prior to the start of the study or during the study period.
- Being an employee or relative of an employee of Ifakara Health Institute.
- Current participation in another clinical trial or recent participation within 12 weeks of enrolment.
- Prior receipt of an investigational malaria vaccine.
- Previous receipt of malaria sporozoites (PfSPZ) or infected RBC as part of the malaria challenge study.
- Use of immunoglobulins or blood products within 3 months prior to enrolment.
- Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination.
- Confirmed parasite positive by qPCR at screening (can be treated and rescreened if time allows)
- History of epilepsy in the period of five years prior to study onset, even if no longer on medication.
- Any history of treatment for severe psychiatric disease by a psychiatrist in the past year.
- History of drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset.
- Known hypersensitivity to or contra-indications (including co-medication) for use of Piperaquine, doxycycline, chloroquine, primaquine, artemether-lumefantrine or history of severe (allergic) reactions to blood transfusion.
- Any other condition or situation that would, in the opinion of the investigator, place the volunteer at an unacceptable risk of injury or render the volunteer unable to meet the requirements of the protocol
Key Trial Info
Start Date :
January 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06172686
Start Date
January 9 2024
End Date
June 30 2024
Last Update
December 15 2023
Active Locations (1)
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1
Ifakara Health Institute
Pwani, Tanzania