A Randomised, Controlled, Double-blind, Parallel Group, Single Center Phase Ib Trial to Assess Safety, Reactogenicity and Immunogenicity of a Candidate Dual-stage Malaria Vaccine, SumayaVac-1 (MSP-1 With GLA-SE as Adjuvant) in Healthy Malaria Exposed Adults of African Origin Aged 18-45 Years

P2267-22

Malaria remains a major infectious disease causing a heavy burden of mortality and morbidity in populations living in tropical and subtropical regions. Large, international research efforts have been invested into the development of anti-malaria vaccination strategies, however, currently there is only one malaria vaccine approved for use in the pediatric population, which provides a moderate and short-lived protection. Therefore, there is a need to develop a malaria vaccine that will be essential to further strengthen malaria control measures in future. A Phase Ia trial with the same IMP (SumayaVac-1 vaccine developed using a full-length recombinant MSP-1 administered along with the adjuvant GLA-SE) in Caucasians in Heidelberg, Germany, proved to be well tolerated and safe. However, a Phase Ib clinical trial on healthy participants residing in a malaria endemic country would be essential to evaluate the safety and reactogenicity in the target population. The project aims to investigate the safety, reactogenicity, immunogenicity of the candidate malaria vaccine, SumayaVac-1 (SUM-101) in 40 healthy participants (men and women) of African origin in Bagamoyo, Tanzania.

2023-08-25

2024-04-02

2024-04-02

Completed

Early phase I

40

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.

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2024-04-15