malaria Plasmodium falciparum
Conditions
Interventions
Single intravenous or subcutaneous administration of TB31F
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Subject must sign written informed consent to participate in the trial. * Subject is able to understand planned study procedures and demonstrate comprehension of the protocol procedures and knowledge of study by passing a quiz. * In the opinion of the investigator, the subject can and will comply with the requirements of the protocol. * Subjects are available to attend all study visits and are reachable by phone throughout the entire study period from day -1 until day 84 (end of study). * The subject will remain within reasonable travelling distance from the study center from day -1 till day +7 after mAb TB31F administration. * Subject is a male or non-pregnant female age * 18 and * 35 years and in good health at time of mAb administration. * Subject agrees to their general practitioner (GP) being informed about participation in the study and agrees to sign a form to request the release by their GP, and medical specialist when necessary, of any relevant medical information concerning possible contra-indications for participation in the study to the investigator(s). * The subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period according to current Sanquin guidelines. * Female subjects of non-childbearing potential may be enrolled in the study. All subjects must agree to use continuous adequate contraception until 2 months after completion of the study.
Exclusion criteria
Exclusion criteria: (Protocol section 4.3.) * Acute or chronic disease at time of TB31F administration, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests: o Acute disease is defined as the presence of a moderate or severe illness with or without fever. Subjects with a minor illness on the day of TB31F administration will be temporarily excluded from participation, but may be re-evaluated for inclusion at a later date. Subjects with a positive SARS-CoV2 test at inclusion will be (temporarily) excluded from participation but may be re-evaluated for inclusion at a later date (following current Radboudumc guidelines). o Fever * 38.0°C (100.4°F). o Any abnormal and clinically significant baseline laboratory screening tests (appendix 1). * History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years. * 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 anti-histamines exempted) or expected use of such during the study period. * Positive urine toxicology test for cannabis, cocaine or amphetamines at screening or at inclusion. * Screening tests positive for Human Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV), Hepatitis C Virus (HCV). * Use of any investigational or non-registered product (drug or vaccine) during the study period other than the study product. * Participation in any other clinical study in the 30 days prior to the start of the study or during the study period. * History of adverse reactions to monoclonal antibodies * Prior receipt of an investigational antimalarial monoclonal antibody. * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study mAb or planned administration during the study period. * Any history of malaria, positive serology for P. falciparum, or previous participation in any malaria (vaccine) study or CHMI. * Body weight > 115 kg * Being an employee or student of the department of Medical Microbiology or Medium Care of the Radboudumc. * History of drug or alcohol abuse interfering with normal function in the period of one year prior to study onset. * Any other condition or situation that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (protocol section 8.1.1) - Number and severity of solicited local adverse events of all severities from first product administration through day 7; - Number and severity of solicited general AEs from first product administration through day 28; - Number and severity of unsolicited adverse events from first product administration through end of study; - Number and severity of serious adverse events from first product administration through end of study. | — |
Secondary
| Measure | Time frame |
|---|---|
| (protocol section 8.1.1) - TB31F serum concentration at each dose level through end of study; - Percentage of transmission reducing activity at different time points by SMFA. | — |
Countries
Netherlands
Outcome results
None listed