Trial to Evaluate the Safety and Immunogenicity of a Placental Malaria Vaccine Candidate (PRIMVAC ) in Healthy Adults
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the safety of 3 different dosages (20µg -
      50µg and 100µg) of a placental malaria vaccine candidate (PRIMVAC vaccine) adjuvanted either
      with Alhydrogel® or GLA-SE, and administered at D0, D28 and D56 in healthy European and
      Burkinabe adults.

      The safety and the tolerability of the vaccine will be assessed on the rate of solicited and
      unsolicited events/reactions The safety profile will included local and systemic
      reactions/events as well as the biological safety, based on a clinically significant change
      of the baseline value of the main biological criteria
    

Detailed description: 
      The project aims are:

        -  Primary objective is to evaluate the safety of 3 different dosages (20µg - 50µg and
           100µg) of the PRIMVAC vaccine adjuvanted either with Alhydrogel® or GLA-SE, and
           administered at D0, D28 and D56 in healthy European and Burkinabe adults.

        -  Secondary objectives are to assess:

             -  the humoral immune response to the PRIMVAC vaccine antigen (VAR2CSA) by measuring
                the variation in the level of total IgG and the level of the isotypic subtypes
                capable of recognizing the native antigen.

             -  the cellular immune response by measuring:

                  -  the number of T cell secreting IL5 and IFNg following an ex-vivo stimulation
                     with the vaccine antigen

                  -  the B lymphocyte phenotypes isolated from PBMC

        -  Exploratory objectives are:

             -  To explore the quality of the humoral immune response by the measure of the
                capability of the antibodies specific to the vaccine antigen to:

                  -  Cross-react with different VAR2CSA variants expressed on the surface of
                     erythrocytes infected by various strains of Plasmodium falciparum,

                  -  Inhibit interactions between parasitized erythrocytes expressing different
                     VAR2CSA variants and Chondroitin Sulfate A (receptor involved in placental
                     sequestration),

                  -  Promote opsonic phagocytosis of parasitized erythrocytes with various strains
                     of Plasmodium falciparum expressing different VAR2CSA variants

             -  To explore the quality of the cellular immune response induced by the vaccine
                antigen by the quantitation of a large panel of cytokines in the ELISpot
                supernatants.
    

Intervention name(s): PRIMVAC; GLA-SE; Alhydrogel; Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 3 different dosages of VAR2CSA protein (20µg - 50µg and 100µg); 2.56 µg of GLA content; 0.85 mg og Aluminium content; 0.9% Na cl
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Placental malaria vaccine; Plasmodium; PRIMALVAC