FMP2.1/AS02A: Rabies Vaccine Malaria-Experienced Adults in Bandiagara, Mali
Condition: Malaria; Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      The primary objective of this study is to evaluate the safety and reactogenicity of two dose
      levels of WRAIR's AMA1 malaria antigen (FMP2.1) adjuvanted in GlaxoSmithKline Biologicals'
      AS02A compared to rabies vaccine in malaria-experienced Malian adults aged 18-55 years
      inclusive. Secondary objectives are to: (1) measure the magnitude and duration of antibody
      response to FMP2.1; (2) measure cellular immune responses to FMP2.1 at baseline and after
      immunization; (3) measure the inhibition of parasite growth by the in vitro GIA; and (4)
      determine the specificity of the antibodies to diverse AMA1 genotypes in addition to 3D7, by
      measuring by ELISA, and GIA on parasites with typed AMA1. A double-blind controlled dose
      escalation trial will allow assessment of vaccine safety in each of three groups, one group
      each to receive medium and full dose levels of the experimental vaccine, and one group to
      receive the comparator vaccine. Thirty adults will be randomized to receive the medium dose
      level of FMP2.1 (n=20) or rabies vaccine (n=10) and thirty to receive the full dose level of
      FMP2.1 (n=20) or rabies vaccine (n=10). The division of the rabies group into two groups of
      ten is done to maintain blinding at each immunization time point, and all participants who
      receive the rabies vaccine will be analyzed as a single group. The sample size of the groups,
      however, will not allow detection of anything other than very large differences in the
      occurrence of adverse events among the three groups. The advantage of double blinding is to
      remove the potential for investigator and participant prejudgment about the effects of the
      vaccines in the reporting of adverse events.
    

Intervention name(s): FMP2.1/AS02A; Rabies vaccine (RabAvert)
Intervention type(s): Biological; Biological
Intervention description(s): FMP2.1 in GSK Biologicals' AS02A; RabAvert Rabies vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Plasmodium falciparum Malaria, Mali, adjuvant