Safety Study of Candidate Malaria Vaccine FMP1/AS02A in Healthy Adults in Bandiagara, Mali
Condition: Malaria
MeSH terms: Malaria
Intervention: FMP1/AS02A; Imovax Rabies Vaccine
Intervention description: FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid.; Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, <150g of neomycin sulfate, and >2.5 IU of rabies antigen.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Plasmodium falciparum; malaria; merozoite surface protein-1

Summary:

      This study tested the safety of a new malaria vaccine in adults in Mali, West Africa, and
      measured the ability of the vaccine to stimulate antibodies directed against the malaria
      protein that the vaccine is based on. Forty adults were randomly assigned to get either the
      experimental malaria vaccine or a rabies vaccine, for comparison.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or non-pregnant female aged 18-55 years inclusive at the time of screening.

          -  For women, willingness not to become pregnant until 1 month after the last dose of
             vaccine

          -  Written informed screening and study consent obtained from the participant before
             study start.

          -  Available and willing to participate in follow-up for the duration of study (12
             months)

        Exclusion Criteria:

          -  Previous vaccination with an investigational malaria vaccine or with any rabies
             vaccine.

          -  Use of any investigational or non-registered drug or vaccine other than the study
             vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use up
             to 30 days after the third dose.

          -  Chronic administration (defined as more than 14 days) of immuno-suppressants or other
             immune-modifying drugs within six months prior to the first vaccine dose. This will
             include oral steroids and inhaled steroids, but not topical steroids.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             within 30 days before the first dose of study vaccine(s) with the exception of tetanus
             toxoid.

          -  Previous vaccination with a vaccine containing MPL and/or QS-21 such as RTS,S.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus (HIV) infection.

          -  Any 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 or neomycin

          -  History of splenectomy

          -  Serum ALT >=35 IU/L

          -  Serum creatinine level >133 micro moles per Liter (1.5 mg/dL)

          -  Hb <11 g/dL for males and <10 g/dL for females

          -  WBC <3.0 x 103/mm3 or >13.5 x 103/mm3

          -  Absolute lymphocyte count <=1.0 x 103 per micro liter

          -  Thrombocytopenia < 100,000 per micro liter

          -  More than trace protein, more than trace hemoglobin or positive glucose in urine

          -  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.

          -  Suspected or known current alcohol or illicit drug abuse.

          -  Pregnancy or positive urine beta-HCG on the day of or prior to immunization.

          -  Breastfeeding

          -  Simultaneous participation in any other interventional clinical trial.

          -  Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurologic condition, or
             any other findings that in the opinion of the PI may increase the risk to the
             participant from participating in the study.

          -  Other condition that in the opinion of the investigator would jeopardize the safety or
             rights of a participant in the trial or would render the participant unable to comply
             with the protocol