Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT07124156
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent obtained before any study procedure.
* Literate participants aged ≥18 - ≤45 years of African origin.
* Female and male participants willing to practice effective contraception from 4 weeks before 1st vaccination (female participants only) and up to 12 weeks after the last vaccination or CHMI (female and male participants)
* Female participants must be willing to undergo multiple serum pregnancy tests.
* Available to participate in follow-up for the duration of the study, including the CHMI in-patient confinement period.
* Contactable by phone during the whole study period.
* At least two years of residence in the Bagamoyo district or nearby districts in the Coastal and Dar-es-Salaam regions and planning to reside there for at least 9 more months.
* Agreement to provide personal contact information and contact information of another household member or close friend.
* Confirmation of understanding of design, procedures, risks and benefits of the study by scoring 10 out of 10 in a structured ten questions with a maximum of two attempts.
* General good health based on assessment of medical history and clinical examination.
* The volunteer agrees to refrain from blood donation for 12 months following CHMI.
* Volunteer agrees to refrain from intensive physical exercise (disproportionate to the volunteer's usual daily activity or exercise routine) during the malaria challenge period.
Exclusion Criteria:
* Previous participation in any malaria vaccine trial in the last 3 years.
* Participation in any other clinical trial involving investigational medicinal products within 30 days prior to the screening assessment.
* Previous history of drug or alcohol abuse interfering with normal social function within one year prior to enrolment.
* Previous vaccination with a rabies vaccine.
* High anti-schizont antibody level as measured by ELISA at screening.
* Intake of chronic medication, especially immunosuppressive agents (steroids, immunomodulating drugs) during the 13 weeks preceding the screening visit or during the study period.
* Known hypersensitivity to any of the vaccine components (adjuvant or protein) or anti-malarial treatments.
* Body mass index (BMI) of ≤18 or ≥30 Kg/m2.
* Participants are unable to be closely followed for social, geographic or psychological reasons.
* Any vaccination from 4 weeks prior to the 1st vaccination and (none planned) up to 8 weeks after the 3rd vaccination.
* Any history, or evidence at screening, of clinically significant symptoms, physical signs or laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, neurological, psychiatric, allergy, endocrine, malignant, haematological, infectious disease, epilepsy and other conditions, which could interfere with the interpretation of the trial results or compromise the health of the participants.
* Abnormal electrocardiogram on screening: pathologic Q wave and significant ST-T wave changes, left ventricular hypertrophy, clinically significant arrhythmias, left bundle branch block, secondary or tertiary A-V (atrio-ventricular) heart block.
* Any clinically significant laboratory values at screening outside of normal ranges for study participants.
* Malaria positivity at screening (microscopy or qPCR positive).
* Positive HIV, Hepatitis B (HBV) or Hepatitis C (HCV) tests. (The testing will only be requested on the discretion of clinician)
* For females: Positive pregnancy test or actively breastfeeding.
* 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 investigators discretion or within a month prior to 1st vaccination or CHMI )
* 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 chloroquine, artemether-lumefantrine, Primaquine or history of severe (allergic) reactions to blood transfusion.
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07124156
Study Brief:
Protocol Section:
NCT07124156