Evaluate the Safety and Efficacy of Plasmodium Falciparum Malaria Protein 010 (FMP010) Administered With Adjuvant AS01B
Condition: Malaria
MeSH terms: Malaria; Malaria, Falciparum
Intervention: Plasmodium falciparum Malaria Protein 010 (FMP010); Rabipur
Intervention description: Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK; Rabipur is a licensed rabies vaccine.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine whether an investigational malaria vaccine is safe
      and induces an immune response against malaria when tested in adults living in the United
      States.
    

Eligibility criteria:

        Inclusion Criteria:

          -  • A male or non-lactating female 18 to 50 years of age (inclusive) at the time of
             screening

               -  Free of significant health problems as established by medical history and
                  clinical examination before entering into the study

               -  Available to participate for duration of study (approximately seven months)

        If the subject is female, she must be of non-childbearing potential (either surgically
        sterilized or one year post-menopausal) or, if of childbearing potential, she must have a
        negative pregnancy test at the time of vaccination, be capable of preventing pregnancy for
        at least one month prior to determination of eligibility (to include abstinence or
        contraceptives (for example intrauterine contraceptive device; oral contraceptives;
        Norplant® or Depo-Provera® ), and must agree to continue such precautions for two months
        after completion of the vaccination series.

        Written informed consent must be obtained from the subject before screening procedures.

        Exclusion Criteria:

          -  • Prior receipt of any investigational malaria vaccine

               -  Prior receipt of a vaccine containing either QS-21, MPL or AS02A or AS01B

               -  Use of any investigational or non-registered drug or vaccine other than the study
                  vaccine within 30 days preceding the first dose of study vaccine, or planned use
                  during the study period

               -  Administration of chronic (defined as more than 14 days) immunosuppressants or
                  other immune modifying drugs within six months of vaccination. For
                  corticosteroids, this is defined as prednisone, or equivalent, 0.5 mg/kg/day.
                  Inhaled and topical steroids are allowed.

               -  Planned administration of a vaccine not foreseen by the study protocol within 30
                  days of the first dose of the study vaccine.

               -  Any confirmed or suspected immunosuppressive or immunodeficient condition,
                  including human immunodeficiency virus (HIV) infection

               -  A family history of congenital or hereditary immunodeficiency

               -  Chronic or active neurologic disease including seizure disorder

               -  History of splenectomy

               -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or
                  renal functional abnormality, as determined by physical examination or abnormal
                  baseline laboratory screening tests

                    -  ALT above normal range

                    -  Creatinine above normal range

                    -  Hemoglobin below normal range

                    -  Platelet count below normal range

                    -  Total white cell count below normal

               -  Acute disease at the time of enrollment (acute disease is defined as the presence
                  of a moderate or severe illness with or without fever). All vaccines can be
                  administered to persons with a minor illness, such as diarrhea or mild upper
                  respiratory infection without fever, i.e. Oral temperature < 37.5°C.

               -  Hepatomegaly, right upper quadrant abdominal pain or tenderness

               -  Administration of immunoglobulins and/or any blood products within the three
                  months preceding the first dose of study vaccine or planned administration during
                  the study period

               -  Pregnant or lactating female

               -  Suspected or known current alcohol abuse/drug abuse as obtained by history and
                  physical examination

               -  Female who is willing or intends to become pregnant during the study

               -  Any history of allergic reaction or anaphylaxis to previous vaccination

               -  Unwilling to allow blood samples to be stored for future use

               -  Inability to make follow up visits

               -  Allergy to kanamycin, nickel, or imidazole

               -  Any other significant finding that in the opinion of the investigator would
                  increase the risk of having an adverse outcome from participating in this study

               -  Previous allergy to Rabies Vaccine

               -  Allergy to chicken and chicken products