Double-blind, Randomized, Controlled Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine
Condition: Malaria, Falciparum
MeSH terms: Malaria; Malaria, Falciparum
Intervention: FMP1/AS02A; RabAvert
Intervention description: FMP1/AS02A candidate malaria vaccine; RabAvert rabies vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects were screened no more than 45 days prior to the first inoculation and were randomized on the first day of vaccination 1:1 between two arms (FMP1/AS02A and rabies vaccine (RabAvert)).
Masking: Double (Participant, Investigator)
Masking description: Both study participants and those investigators responsible for evaluation of the endpoints will be blinded as to who receives the test article versus the comparator. On vaccination days, the comparator vaccine will be in the same package as received from the manufacturer. After agitation it will appear clear and pink. The FMP1 antigen and the AS02A adjuvant will be packaged separately. The reconstituted FMPI antigen in the AS02A adjuvant/diluent will have a milky white appearance. Because the vaccines will have a markedly different appearance, contents of the syringe will be concealed as described later in this section. The two vaccine preparation teams, consisting of the study pharmacist, pharmacy assistants, and drug manager (an experienced nurse, clinician, or pharmacist), will be responsible for vaccine preparation. They will also verify that the proper vaccine and vaccine dose is prepared and delivered to each subject.
Enrollment: 400.0
Sex: All
Minimum age: 12 Months
Maximum age: 47 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Plasmodium; falciparum; malaria; vaccine; AS02A adjuvant; FMP1; Merozoite surface protein-1

Summary:

      This trial is currently evaluating one candidate malaria vaccine, FMP1/AS02A. This candidate
      malaria vaccine is being developed for the routine immunization of infants and children
      living in malaria-endemic areas. This vaccine would offer protection against malaria disease
      due to the parasite Plasmodium falciparum.

      Prior to the start of this study, FMP1/AS02A had been given to approximately 60 malaria-naïve
      adults and 40 adults and 90 children living in malaria-endemic regions.

      This study will investigate whether the candidate vaccine prevents malaria disease for 6
      months post-vaccination.

      One half of the enrolled subjects will receive FMP1/AS02A and the other half rabies vaccine
      (RabAvert).
    

Eligibility criteria:

        Inclusion Criteria:

        All subjects must satisfy the following criteria at study entry:

          -  A healthy male or female child, 12 to 47 months of age on the day of screening

          -  Written informed consent obtained from at least one parent/guardian before study start

          -  Available to participate for the study duration (about 14 months)

        Exclusion Criteria:

          -  Acute disease at the time of entry into the study that in the opinion of the
             investigator may pose a threat to the subject

          -  Prior receipt of a rabies vaccine or any investigational 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 corticosteroids, 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/AS02A)

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus (HIV) infection. (No HIV test will be performed as part
             of this study.)

          -  History of allergic reactions or anaphylaxis to immunizations or to any vaccine
             components, such as eggs

          -  History of surgical splenectomy

          -  Administration of immunoglobulins, blood transfusions, or any other blood products
             within the six 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 that 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