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:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT05644067
Eligibility Criteria:
Inclusion Criteria:
1. Written informed consent obtained before any study procedure.
2. Literate participants aged 18-45 years of African origin.
3. Female participants practicing contraception from 4 weeks before 1st immunization and both female and male participants willing to practice contraception up to 12 weeks after the last immunization.
4. Available to participate in follow-up for the duration of the study.
5. Contactable by phone during the whole study period.
6. At least two years residence in the Bagamoyo district or nearby districts in Coastal and Dar-es-Salaam regions and planning to reside there for at least 9 more months.
7. Agreement to provide personal contact information and contact information of another household member or close friend.
8. Female participants must be willing to avoid pregnancy if selected for participation in the trial and to undergo multiple serum pregnancy testing.
9. Confirmation of understanding of design, procedures, risk and benefits of the study in a test with maximum of two attempts.
10. General good health based on assessment of medical history and clinical examination.
Exclusion Criteria:
1. Previous participation in any malaria vaccine trial in the last 3 years.
2. Participation in any other clinical trial involving investigational medicinal products within 30 days prior to the screening assessment.
3. Previous history of drug or alcohol abuse interfering with normal social function within one year prior to enrolment.
4. Previous vaccination with a rabies vaccine.
5. Intake of chronic medication, especially immunosuppressive agents (steroids, immunomodulating drugs) during the 13 weeks preceding the screening visit or during the study period.
6. Known hypersensitivity to any of the vaccine components (adjuvant or protein) or anti-malarial treatments.
7. Body mass index (BMI) of \<18 or \>30 Kg/m2.
8. Participants unable to be closely followed for social, geographic or psychological reasons.
9. Any vaccination from 4 weeks prior to the 1st vaccination and (none planned) up to 6 weeks after the 3rd vaccination.
10. Symptoms, physical signs or laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the trial results or compromise the health of the participants.
11. 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.
12. Any clinically significant laboratory values at screening outside of normal ranges for study participants.
13. Malaria positivity at screening (microscopy or qPCR positive).
14. Positive HIV, HBV or HCV tests.
15. For females: Positive pregnancy test or actively breast feeding.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05644067
Study Brief:
Protocol Section:
NCT05644067