Phase I Pediatric FMP2.1/AS02A Trial in Mali
Condition: Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Intervention: FMP2.1/AS02A; Rabies vaccine (RabAvert)
Intervention description: FMP2.1 will be reconstituted in AS02A adjuvant. Dosages: 10, 25, or 50 mcg of FMP2.1 or 0.1, 0.25 or 0.5 mL of FMP2.1/AS02A administered by intramuscular injection.; RabAvert, white, freeze-dried vaccine for reconstitution with diluent. Dosage: 1.0 mL of rabies vaccine.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 100.0
Sex: All
Minimum age: 1 Year
Maximum age: 6 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: malaria, vaccine, Mali, children

Summary:

      The purpose of this study is to test the safety and dosages of a malaria vaccine in 100
      children, 1-6 years old, in Bandiagara, Mali. The study is testing the safety of the vaccine
      when it is given to people who are regularly exposed to malaria and it will provide
      information regarding optimal vaccine dosage. This study will compare 3 injections of
      different vaccine doses to a rabies vaccine that is already approved. During the study, the
      child's health will be checked in the clinic and during home visits. Children may participate
      for about 14 months, and blood will be taken from each child throughout the study. If the
      child becomes sick from malaria, he/she will be treated. Information from this study may be
      used to develop a malaria vaccine that will help control the disease.
    

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.