Phase I Pediatric FMP2.1/AS02A Trial in Mali
Plasmodium Falciparum Malaria
About this trial
This is an interventional prevention trial for Plasmodium Falciparum Malaria focused on measuring malaria, vaccine, Mali, children
Eligibility Criteria
Inclusion Criteria: Age 1-6 years inclusive at the time of screening. Residing in Bandiagara town. Appear to be in generally good health based on clinical and laboratory investigation. Separate written informed consent obtained from the parent/guardian before screening and study start, respectively. Available to participate in follow-up for the duration of study (14 months). Exclusion Criteria: Previous vaccination with an 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. History of allergy to tetracycline, doxycycline, nickel or Imidazole. History of splenectomy. Laboratory evidence of liver disease (alanine aminotransferase [ALT] greater than the upper limit of normal of the testing laboratory = 49.6 U/L). Laboratory evidence of renal disease (serum creatinine greater than the upper limit of normal of the testing laboratory = 0.5 mg/dL (44.2 micromol/L), or more than trace protein or blood on urine dipstick testing). Laboratory evidence of hematologic disease (absolute leukocyte count <5,300/mm^3 or >15,300/mm^3, absolute lymphocyte count <2,300 mm^3, platelet count <133,000/mm^3, or hemoglobin <9.0 g/dL). Chronic skin condition that could interfere with vaccine site reactogenicity assessment. 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, severe malnutrition, or any other clinical findings that in the opinion of the Principal Investigator (PI) may increase the risk of participating in the study. Other condition that in the opinion of the PI would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol.
Sites / Locations
- University of Bamako, Malaria Research and Training Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Group 1: FMP2.1/AS02A 10 mcg dose or rabies vaccine.
Group 2: FMP2.1/AS02A 25 mcg dose or rabies vaccine.
Group 3: FMP2.1/AS02A 50 mcg dose or rabies vaccine.
20 children will be randomized to receive either the 10 mcg dose of FMP2.1/AS02A (n=15) or rabies vaccine (n=5) on study days 0, 30 +/- 7, and 60 +/- 7.
40 children will be randomized to receive either the 25 mcg dose of FMP2.1/AS02A (n=30) or rabies vaccine (n=10) on study days 0, 30 +/- 7, and 60 +/- 7.
40 children will be randomized to receive either the 50 mcg dose of FMP2.1/AS02A (n=30) or rabies vaccine (n=10) on study days 0, 30 +/- 7, and 60 +/- 7.