FMP2.1/AS02A: Rabies Vaccine Malaria-Experienced Adults in Bandiagara, Mali
Condition: Malaria; Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Intervention: FMP2.1/AS02A; Rabies vaccine (RabAvert)
Intervention description: FMP2.1 in GSK Biologicals' AS02A; RabAvert Rabies vaccine
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Plasmodium falciparum Malaria, Mali, adjuvant

Summary:

      Malaria is a disease that affects many people in Africa and in Mali. It is caused by germs
      that are spread by mosquito bites. This study will look at the safety, effectiveness, and
      best dose of an experimental malaria vaccine in people who are regularly exposed to malaria.
      Study participants will be 60 adults, 18-55 years old, who live in Bandiagara, Mali.
      Volunteers will get either 3 full doses of the experimental malaria vaccine, 3 half doses of
      the malaria vaccine, or a rabies vaccine that has been approved in Mali. (Rabies is an
      infection of the brain that usually causes death, and can be caught from being bitten by
      infected dogs or bats.) The 3 vaccinations will be given by injection into the upper arm 30
      days apart. Volunteers will be enrolled in the study for approximately 12 months after the
      first vaccination. Volunteers will have 14 blood samples collected during the study for
      testing to make sure that the vaccine is not harmful and to measure the effect of the
      vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. A male or non-pregnant female aged 18-55 years inclusive at the time of screening

          2. For women, willingness not to become pregnant until 1 month after the last
             immunization (pre-menopausal female participants will be referred to the local family
             planning clinic in Bandiagara, which offers several means of contraception that are
             approved and recommended by the Malian Ministry of Health)

          3. Separate written informed consent obtained from the participant before screening and
             study start, respectively

          4. Available and willing to participate in follow-up for the duration of study (12
             months)

        Exclusion Criteria:

          1. Previous vaccination with any investigational vaccine or with any rabies vaccine

          2. Use of any 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

          3. Chronic administration (defined as more than 14 days) of immuno-suppressants or other
             immune-modifying drugs within six months prior to the first immunization. This will
             include any dose level of oral steroids or inhaled steroids, but not topical steroids

          4. Planned administration/administration of a vaccine not foreseen by the study protocol
             within 30 days before the first study immunization with the exception of tetanus
             toxoid

          5. Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus (HIV) infection

          6. Any confirmed or suspected autoimmune disease

          7. History of allergic reactions or anaphylaxis to immunizations or to any vaccine
             component

          8. History of serious allergic reactions to any substance, requiring hospitalization or
             emergent medical care

          9. History of allergy to tetracycline, doxycycline, nickel, Imidazole, chicken eggs,
             processed bovine gelatin, chicken protein, neomycin, or amphotericin B

         10. History of splenectomy

         11. Serum ALT >/=43 IU/L

         12. Serum creatinine level >113 µmol /L for males and 70 µmol /L for females

         13. Hgb <11 g/dL for males and <10 g/dL for females

         14. WBC <4.0 x 1000/cubic mm or >13 x 1000/cubic mm

         15. Absolute lymphocyte count </=1.4 x 1000 /µl

         16. Thrombocytopenia < 108,000/µl

         17. More than trace protein, more than trace hemoglobin or positive glucose in urine

         18. Administration of immunoglobulins and/or any blood products within the three months
             preceding the first study immunization or planned administration during the study
             period

         19. Suspected or known current alcohol or illicit drug abuse

         20. Pregnancy or positive urine beta-HCG on the day of or prior to immunization

         21. Breastfeeding

         22. Simultaneous participation in any other interventional clinical trial

         23. Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurological condition,
             or any other findings that in the opinion of the Principal Investigator (PI) may
             increase the risk of participating in the study

         24. 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