In-vivo Transmission model in semi-immune adults

Phase 1

Not yet recruiting

• Conditions: Malaria

• Registration Number: PACTR202312585218142
• Lead Sponsor: Ifakara Health Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-04
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

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 Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified