Safety of Recombinant Hybrid GMZ 2 [GLURP + MSP 3] Blood Stage Malaria Vaccine

This is an interventional prevention trial for Malaria focused on measuring Malaria, Vaccine, GMZ2, Safety, African, immunogenicity Read More

Inclusion Criteria:

• Adult male Gabonese 18-45 years inclusive at the time of screening
• Residing in Lambarene for the duration of the study
• Separate written informed consent obtained before screening and study start respectively
• Available to participate in follow-up for the duration of study (13 months)
• General good health based on history and clinical examination

Exclusion Criteria:

• Previous vaccination with a investigational vaccine or a rabies vaccine
• Use of a investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first study immunization, or planned use up to 30 days after the third immunization
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first immunization. This includes any dose level of oral steroids or inhaled steroids, but not topical steroids
• Confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
• Confirmed or suspected autoimmune disease
• History of allergic reactions or anaphylaxis to immunizations or to any vaccine component
• History of serious allergic reactions to any substance, requiring hospitalization or emergent medical care,or history of allergy to vaccines components
• History of splenectomy
• Laboratory evidence of liver disease (alanine aminotransferase [ALT] greater than 1.25 times the upper limit of normal of the testing laboratory).
• Laboratory evidence of renal disease (serum creatinine greater than the upper limit of normal of the testing laboratory, or more than trace protein or blood on urine dipstick testing).
• Laboratory evidence of hematologic disease (absolute leukocyte count 3.5-11/µL, absolute lymphocyte count 560-5280/µL, platelet count 120,000-400,000/µL, or hemoglobin 10.0-16.5g/dL).
• Administration of immunoglobulins and/or any blood products within the three months preceding the first study immunization or planned administration during the study period.
• Simultaneous participation in any other interventional clinical trial
• Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurological condition, malnutrition, or any other clinical findings that in the opinion of the clinical investigator may increase the risk of participating in the study
• Other condition that in the opinion of the clinical investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol.