Status:
COMPLETED
A Study of Blood-stage Controlled Human Plasmodium Falciparum Malaria Infection in Tanzania
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Ifakara Health Institute
Conditions:
Malaria
Plasmodium Falciparum
Eligibility:
MALE
18-35 years
Phase:
NA
Brief Summary
This will be a single-centre, open label trial to determine the safety and feasibility of CHMI model using Plasmodium falciparum-infected cryopreserved erythrocytes administered to healthy Tanzanian a...
Detailed Description
This study will be a single-centre controlled human malaria infection study using adults with varying degrees of prior exposure to P. falciparum. The study will take place at Bagamoyo Clinical Trail F...
Eligibility Criteria
Inclusion
- Volunteer being adult male aged ≥ 18 and ≤ 35 years, and in good health.
- Volunteer a resident in Bagamoyo town or rural areas of Bagamoyo district for the past 6 months
- Able and willing to complete the informed consent process conducted in English
- 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.
- Volunteer is willing to complete an informed consent questionnaire and is able to answer all questions correctly in a maximum of two attempts.
- Volunteer is able to communicate well with the investigator and is willing to be monitored in an inpatient setting for 28 days after challenge with infected erythrocytes.
- The volunteer agrees to refrain from blood donation throughout the study period.
- Volunteer agrees to refrain from intensive physical exercise (disproportionate to the volunteer's usual daily activity or exercise routine) during the malaria challenge period.
- Volunteer has signed written informed consent to participate in the trial.
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.
- History of epilepsy in the period of five years prior to study onset, even if no longer on medication.
- 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 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 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's discretion).
- 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)
- Known hypersensitivity to or contra-indications (including co-medication) for use of chloroquine, artemether-lumefantrine, Primaquine or history of severe (allergic) reactions to blood transfusion.
- 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.
- 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.
- Exclusion criteria on day of challenge:
- Acute disease, defined as moderate or severe illness with or without fever
- 2\. Current COVID-19 infection, defined as ongoing symptoms with positive COVID-19 PCR or rapid antigen test taken during current illness or positive COVID-19 PCR or rapid antigen test within preceding 7 days without symptoms.
- History of close contact with COVID-19 confirmed case within preceding 14 days
Key Trial Info
Start Date :
July 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04788862
Start Date
July 18 2022
End Date
February 24 2023
Last Update
May 24 2023
Active Locations (1)
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1
Ifakara Health Institute
Bagamoyo, Tanzania