Safety and immunogenicity of GMZ2 - a MSP3-GLURP fusion protein malaria vaccine candidate

Meral Esen; Peter G Kremsner; Regina Schleucher; Michael Gässler; Egeruan Babatunde Imoukhuede; Nathalie Imbault; Odile Leroy; Søren Jepsen; Birgitte Walther Knudsen; Michael Schumm; Jürgen Knobloch; Michael Theisen; Benjamin Mordmüller

doi:10.1016/j.vaccine.2009.09.011

Safety and immunogenicity of GMZ2 - a MSP3-GLURP fusion protein malaria vaccine candidate

Meral Esen, Peter G Kremsner, Regina Schleucher, Michael Gässler, Egeruan Babatunde Imoukhuede, Nathalie Imbault, Odile Leroy, Søren Jepsen, Birgitte Walther Knudsen, Michael Schumm, Jürgen Knobloch, Michael Theisen, Benjamin Mordmüller

76 Citations (Scopus)

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.

Original language	English
Journal	Vaccine
Volume	27
Issue number	49
Pages (from-to)	6862-8
Number of pages	6
ISSN	0264-410X
DOIs	https://doi.org/10.1016/j.vaccine.2009.09.011
Publication status	Published - 2009

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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-na{\"i}ve 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.",

author = "Meral Esen and Kremsner, {Peter G} and Regina Schleucher and Michael G{\"a}ssler and Imoukhuede, {Egeruan Babatunde} and Nathalie Imbault and Odile Leroy and S{\o}ren Jepsen and Knudsen, {Birgitte Walther} and Michael Schumm and J{\"u}rgen Knobloch and Michael Theisen and Benjamin Mordm{\"u}ller",

note = "Keywords: Adult; Antibodies, Protozoan; Antigens, Protozoan; B-Lymphocytes; Female; Follow-Up Studies; Humans; Immunization, Secondary; Immunologic Memory; Malaria Vaccines; Malaria, Falciparum; Male; Middle Aged; Protozoan Proteins; Recombinant Fusion Proteins; Young Adult",

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doi = "10.1016/j.vaccine.2009.09.011",

language = "English",

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pages = "6862--8",

journal = "Vaccine",

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T1 - Safety and immunogenicity of GMZ2 - a MSP3-GLURP fusion protein malaria vaccine candidate

AU - Esen, Meral

AU - Kremsner, Peter G

AU - Schleucher, Regina

AU - Gässler, Michael

AU - Imoukhuede, Egeruan Babatunde

AU - Imbault, Nathalie

AU - Leroy, Odile

AU - Jepsen, Søren

AU - Knudsen, Birgitte Walther

AU - Schumm, Michael

AU - Knobloch, Jürgen

AU - Theisen, Michael

AU - Mordmüller, Benjamin

N1 - Keywords: Adult; Antibodies, Protozoan; Antigens, Protozoan; B-Lymphocytes; Female; Follow-Up Studies; Humans; Immunization, Secondary; Immunologic Memory; Malaria Vaccines; Malaria, Falciparum; Male; Middle Aged; Protozoan Proteins; Recombinant Fusion Proteins; Young Adult

PY - 2009

Y1 - 2009

N2 - 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.

AB - 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.

U2 - 10.1016/j.vaccine.2009.09.011

DO - 10.1016/j.vaccine.2009.09.011

M3 - Journal article

C2 - 19755144

SN - 0264-410X

VL - 27

SP - 6862

EP - 6868

JO - Vaccine

JF - Vaccine

IS - 49

ER -

Safety and immunogenicity of GMZ2 - a MSP3-GLURP fusion protein malaria vaccine candidate

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