Plasmodium falciparum, strain NF54, sporozoites for Malaria

Inclusion criteria

• {"criterion_text":"-\tHealthy malaria-naive adults aged 18 to 40 years.\n-\tWillingness to take AP or placebo at the scheduled timepoint and a curative antimalarial regimen following CHMI and development of amplifying parasitaemia.\n-\tAnswer all questions on the informed consent quiz correctly.\n-\tAble and willing (in the Investigator’s opinion) to comply with all study requirements\n-\tWilling to allow the investigators to discuss the volunteer’s medical history with their general practitioner if required.\n-\tResidence in or nearby Tübingen with a maximum travel time to our study centre of 1 hour for the study period\n-\tWomen who agree to practice effective contraception for the duration of the study (a method which results in a low failure rate; i.e. less than 1% per year).\n-\tWeight over 40 kg and BMI ≥19 and ≤ 30.\n-\tAgreement to refrain from blood donation during the course of the study and after the end of their involvement in the study according to the local and national blood banking eligibility criteria\n-\tProvision of written informed consent to receive PfSPZ Challenge (NF54) for CHMI.\n-\tReachable (24/7) by mobile phone during the CHMI period."}

Exclusion criteria

• {"criterion_text":"-\tHistory of malaria.\n-\tHistory of seizure (except uncomplicated febrile convulsion at childhood)\n-\tPregnancy, lactation or intention to become pregnant during the study.\n-\tDiagnosis of any immune deficiency disorder, including human immunodeficiency virus (HIV) infection.\n-\tHistory of (functional) asplenia.\n-\tUse of chronic (more than 14 days) systemic immunosuppressive medication within the past 2 years (topical or inhaled immunosuppressive agents are allowed).\n-\tAny other confirmed or suspected immunosuppressive or immunodeficient state (e.g., repeated and/or unusual infection), including history of infection caused by opportunistic organisms, any infection or combination of infections that suggest underlying immunodeficiency, history of meningitis, encephalitis, septic shock, life-threatening soft tissue infection, more than one pneumonia.\n-\tKnown (or signs consistent with) sickle cell anemia, sickle cell trait, thalassemia or thalassemia trait, glucose-6-phosphate dehydrogenase deficiency.\n-\tUse of immunoglobulins or blood products within 3 months prior to enrolment.\n-\tHistory of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).\n-\tAny other serious chronic illness requiring hospital specialist supervision\n-\tHistory of travel to a malaria-endemic country within the previous 12 months.\n-\tHistory of serious psychiatric condition that may affect participation in the study\n-\tSuspected or known current alcohol abuse as defined by an alcohol intake of greater than 24 g (men) or 12 g (women) per day.\n-\tSuspected or known illicit drug abuse in the 5 years preceding enrolment.\n-\tVolunteers unable to be closely followed for social, geographic or psychological reasons.\n-\tAny other significant disease, disorder, finding at medical history, biochemistry, haematology tests, urine analysis results, clinical examination or electrocardiogram (ECG) which, in the opinion of the Investigator, may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.\n-\tDifficulties with venepuncture for blood sampling at screening visit due to veins that easily collapse or roll, are too thin, or are hard to find.\n-\tPositive for hepatitis B surface antigen (HBs-antigen).\n-\tSeropositive for hepatitis C virus (antibodies to HCV).\n-\tAbnormal vital signs\n-\tIntake of medication that potentially interferes with the study intervention or rescue drugs\n-\tReceipt of an investigational product in the 90 days preceding, or planned receipt during the study period.\n-\tContraindication to the use of the following antimalarial medications: AP, artemether-lumefantrine, artesunate.\n-\tUse of medication interacting with AP (e.g. metoclopramide, tetracycline, rifampicin, rifabutin, efavirenz, or nevirapine).\n-\tUse of medication interacting with artemether-lumefantrine (e.g. disopyramide, quinidine, procainamide, amiodarone, rifampicin, carbamazepine, phenytoin, phenobarbital, haloperidol, domperidone, pimozide or pipamperone)."}

Primary endpoints

• {"endpoint_text":"-\tEfficacy endpoint Proportion of protected volunteers. Protection is defined as the absence of amplifying parasitaemia in the peripheral blood for +21 days following CHMI with PfSPZ Challenge (NF54) in volunteers receiving AP (250/100 mg) for chemoprophylaxis. Amplifying parasitaemia is defined as at least one qPCR result above 20 blood-stage parasites per ML followed by a second qPCR result with an at least 4-fold increased blood stage parasitaemia 24-48 hours apartPrimary safety endpoint Numbe","definition_or_measurement_approach":"Protection: absence of amplifying parasitaemia in peripheral blood for 21 days following CHMI. Amplifying parasitaemia defined as at least one qPCR result >20 blood-stage parasites per mL followed by a second qPCR result with at least a 4-fold increase 24–48 hours apart. (Primary safety endpoint text appears truncated in source.)"}

Secondary endpoints

• {"endpoint_text":"-\tSecondary safety endpoint Occurrence of any related AE from time of AP/placebo D0 until the end of the study.","definition_or_measurement_approach":"Occurrence of any adverse event assessed as related from time of AP/placebo dose on D0 until study end (as stated)."}

Germany

Earliest CTIS Part Ii Submission Date

04-11-2024

Latest Decision Or Authorization Date

06-02-2026

Processing Time Days

459

Number Of Sites

1

Number Of Participants

32

Primary sponsor

Full Name

Universitaetsklinikum Tuebingen AöR

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany