title: Safety and immunogenicity of GMZ2 - a MSP3-GLURP fusion protein malaria vaccine candidate.
abstract: Malaria is a major public health problem in Sub-Saharan Africa. In highly endemic regions infants, children and pregnant women are mostly affected. An effective malaria vaccine would complement existing malaria control strategies because it can be integrated in existing immunization programs easily. Here we present the results of the first phase Ia clinical trial of GMZ2 adjuvanted in aluminium hydroxide. GMZ2 is a malaria vaccine candidate, designed upon the rationale to induce immune responses against asexual blood stages of Plasmodium falciparum similar to those encountered in semi-immune individuals. Ten, 30 and 100 microg of GMZ2 were well tolerated in 30 healthy malaria-naïve German volunteers when given three times in monthly intervals. Antigen-specific antibodies as well as memory B-cells were induced and detectable throughout the one year follow-up of the study. We conclude that GMZ2 is a safe and immunogenic malaria vaccine candidate suitable for further clinical development.
authors.affiliation: University of Tübingen, Institute of Tropical Medicine, Wilhelmstrasse 27, D-72074 Tübingen, Germany.
authors.forename: Meral
authors.initials: M
authors.lastname: Esen
authors.forename: Peter G
authors.initials: PG
authors.lastname: Kremsner
authors.forename: Regina
authors.initials: R
authors.lastname: Schleucher
authors.forename: Michael
authors.initials: M
authors.lastname: Gässler
authors.forename: Egeruan Babatunde
authors.initials: EB
authors.lastname: Imoukhuede
authors.forename: Nathalie
authors.initials: N
authors.lastname: Imbault
authors.forename: Odile
authors.initials: O
authors.lastname: Leroy
authors.forename: Søren
authors.initials: S
authors.lastname: Jepsen
authors.forename: Birgitte Walther
authors.initials: BW
authors.lastname: Knudsen
authors.forename: Michael
authors.initials: M
authors.lastname: Schumm
authors.forename: Jürgen
authors.initials: J
authors.lastname: Knobloch
authors.forename: Michael
authors.initials: M
authors.lastname: Theisen
authors.forename: Benjamin
authors.initials: B
authors.lastname: Mordmüller
mesh_terms: D000328:Adult; D000913:Antibodies, Protozoan / Q000097:blood*; D000953:Antigens, Protozoan / Q000276:immunology*; D001402:B-Lymphocytes / Q000276:immunology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007117:Immunization, Secondary; D007156:Immunologic Memory; D017780:Malaria Vaccines / Q000009:adverse effects / Q000276:immunology*; D016778:Malaria, Falciparum / Q000276:immunology / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D015800:Protozoan Proteins / Q000276:immunology*; D011993:Recombinant Fusion Proteins / Q000276:immunology; D055815:Young Adult
chemical_list: D000913:Antibodies, Protozoan; D000953:Antigens, Protozoan; C000599052:GMZ2 vaccine; D017780:Malaria Vaccines; D015800:Protozoan Proteins; D011993:Recombinant Fusion Proteins; C089133:merozoite surface protein 3, Plasmodium; C072492:glutamate-rich protein, Plasmodium