Phase II AMA-1 Malaria Vaccine FMP2.1/AS02A Trial in Mali
Condition: Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Intervention: FMP2.1/AS02A; Rabies Vaccine
Intervention description: 3 doses administered a month apart: 50 µg recombinant subunit protein FMP2.1 (Plasmodium falciparum Apical Membrane Antigen-1 from strain 3D7 expressed in and purified from Escherichia coli), adjuvanted with 0.5 mL of AS02A (proprietary oil-in-water emulsion and phosphate buffered saline with the immunostimulants monophosphoral lipid A and QS21).; White, freeze-dried vaccine for reconstitution with the diluent prior to use; dosage 1.0 mL of rabies vaccine.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 400.0
Sex: All
Minimum age: 1 Year
Maximum age: 6 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: malaria, Mali, children, Plasmodium falciparum, vaccine

Summary:

      Malaria is a disease that affects many people in Africa. Malaria is caused by germs spread by
      mosquito bites. The purpose of this study is to compare the number of children who get
      malaria after receiving an experimental malaria vaccine (FMP2.1/AS02A) to the number of
      children who get malaria after receiving a vaccine for rabies (an approved vaccine that does
      not prevent malaria). The children will be assigned to one of the vaccine groups by chance.
      Participants and doctors will not know which vaccine was given. Study participants will
      include 400 children, ages 1-6 years, living in Bandiagara, Mali. Children will receive 3
      vaccine doses, by injection, to their upper arm. Study procedures will include physical exams
      and several blood samples. Participants will be involved in the study for 26 months.
    

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 (26 months)

        Exclusion Criteria:

          -  Previous vaccination with an investigational vaccine or a rabies vaccine

          -  Use of an 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
             exclusion 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, Imidazole, eggs, neomycin,
             chlortetracycline or amphotericin B

          -  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 or plasma creatinine greater than 62 micro
             mol/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)

          -  Hepatitis B surface antigen positive

          -  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 (including hepatomegaly), renal or
             neurological condition, severe malnutrition, or any other clinical findings that in
             the opinion of the PI may increase the risk of participating in the study

          -  Other condition that in the opinion of the Principal Investigator (PI) would
             jeopardize the safety or rights of a participant in the trial or would render the
             participant unable to comply with the protocol