Phase 1 Trial of a Malaria Vaccine in Young Kenyan Children
Condition: Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Intervention: FMP1/AS02A Malaria vaccine; Imovax Rabies vaccine
Intervention description: Subjects vaccinated with FMP1/AS02 vaccine; Subjects vaccinated on corresponding FMP1/AS02A vaccination days
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 135.0
Sex: All
Minimum age: 12 Months
Maximum age: 47 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccine; Phase 1; Plasmodium falciparum; Malaria; Merozoite surface protein-1; MSP-1; Falciparum malaria protein 1; FMP-1; AS02A

Summary:

      To assess the safety and reactogenicity of the FMP-1/AS02A malaria vaccine in malaria-exposed
      children living in western Kenya and aged 12-47 months
    

Eligibility criteria:

        Inclusion Criteria:

          -  A healthy male or female child, 12 to 47 months of age at the time of screening.

          -  Written informed consent obtained from at least one parent before study start.

          -  Available to participate for the duration of the study (12 months).

        Exclusion Criteria:

          -  Acute disease at the time of entry into the study

          -  Axillary temperature of 37.5 degrees C

          -  Respiratory rate 50

          -  Serum ALT 45 IU/l (i.e., > 1.5 X ULN)

          -  Decreased renal function: serum creatinine levels > 92.2 mM/l (> 1.1 mg/dl).

          -  Significant anemia (Hgb <8 gm/dL).

          -  Thrombocytopenia (Platelets < 100,000 per mm3)

          -  Impaired immunity: (Absolute lymphocyte count [ALC] for 1 year olds < 4.0 x 103/mm3;
             for 2 year olds < 3.0 x 103/mm3; for 3 year olds < 2.0 103/mm3.

          -  History of homozygous sickle cell disease (SS).

          -  Malnutrition (Z score; Malnutrition = Weight for height < - 3 z scores)

          -  Blood transfusion or use of blood-based product in previous 6 months.

          -  Prior receipt of a rabies vaccine or an investigational malaria vaccine.

          -  Use of any investigational drug or vaccine other than the study vaccine within 30 days
             preceding the first dose of study vaccine, or planned use up to 30 days after the
             third dose.

          -  Administration of chronic (defined as more than 14 days) immunosuppressants or other
             immune-modifying drugs within six months of vaccination. (For cortico-steroids, this
             will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled
             and topical steroids are allowed).

          -  Administration or anticipated administration of a vaccine not foreseen by the study
             protocol within 30 days of the first dose of vaccine(s) with the exception of tetanus
             toxoid.

          -  Previous vaccination with a vaccine containing MPL or QS21 (e.g., RTS,S).

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus (HIV) infection. (No HIV testing will be undertaken as
             part of this study.)

          -  History of allergic reactions or anaphylaxis to immunizations or to any vaccine
             components.

          -  History of surgical splenectomy.

          -  Administration of immunoglobulins or any blood products within the 3 months preceding
             the first dose of study vaccine or planned administration during the study period.

          -  Simultaneous participation in any other clinical trial.

          -  Acute or chronic cardiovascular, pulmonary, hepatic or renal condition, which in the
             opinion of the PI may increase the risk to the subject from participating in the
             study.

          -  Any other condition or circumstance that in the opinion of the investigator may pose a
             threat to the subject.