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Phase I dose escalation safety and immunogenicity trial of Plasmodium falciparum apical membrane protein (AMA-1) FMP2.1, adjuvanted with AS02A, in malaria-naïve adults at the Walter Reed Army Institute of Research

Polhemus, Mark E ; Magill, Alan J ; Cummings, James F ; Kester, Kent E ; Ockenhouse, Chris F ; Lanar, David E ; Dutta, Sheetij ; Barbosa, Arnoldo ; Soisson, Lorraine ; Diggs, Carter L ; Robinson, Sally A ; Haynes, John D ; Stewart, V. Ann ; Ware, Lisa A ; Brando, Clara ; Krzych, Urszula ; Bowden, Robert A ; Cohen, Joe D ; Dubois, Marie-Claude ; Ofori-Anyinam, Opokua ; De-Kock, Els ; Ballou, W. Ripley ; Heppner, D. Gray

Vaccine, 2007-05, Vol.25 (21), p.4203-4212 [Periódico revisado por pares]

Oxford: Elsevier Ltd

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Título:
Phase I dose escalation safety and immunogenicity trial of Plasmodium falciparum apical membrane protein (AMA-1) FMP2.1, adjuvanted with AS02A, in malaria-naïve adults at the Walter Reed Army Institute of Research
Autor: Polhemus, Mark E ; Magill, Alan J ; Cummings, James F ; Kester, Kent E ; Ockenhouse, Chris F ; Lanar, David E ; Dutta, Sheetij ; Barbosa, Arnoldo ; Soisson, Lorraine ; Diggs, Carter L ; Robinson, Sally A ; Haynes, John D ; Stewart, V. Ann ; Ware, Lisa A ; Brando, Clara ; Krzych, Urszula ; Bowden, Robert A ; Cohen, Joe D ; Dubois, Marie-Claude ; Ofori-Anyinam, Opokua ; De-Kock, Els ; Ballou, W. Ripley ; Heppner, D. Gray
Assuntos: Adjuvants, Immunologic ; Adolescent ; Adult ; Allergy and Immunology ; Animals ; Antibodies, Protozoan - blood ; Antigens, Protozoan - immunology ; Apical membrane antigen ; Applied microbiology ; AS02A ; Biological and medical sciences ; Cell Line ; Cell Proliferation ; Cells, Cultured ; Cricetinae ; Drug Combinations ; Enzyme-Linked Immunosorbent Assay ; Escherichia coli - genetics ; Falciparum ; Female ; Fluorescent Antibody Technique, Indirect ; FMP2.1 ; Fundamental and applied biological sciences. Psychology ; Growth inhibition assay ; Headache ; Human protozoal diseases ; Humans ; Immunization, Secondary ; Infectious diseases ; Interferon-gamma - biosynthesis ; Interleukin-5 - biosynthesis ; Leukocytes, Mononuclear - immunology ; Lipid A - analogs & derivatives ; Lipid A - immunology ; Malaria ; Malaria Vaccines - administration & dosage ; Malaria Vaccines - adverse effects ; Malaria Vaccines - immunology ; Male ; Medical sciences ; Membrane Proteins - immunology ; Merozoites - immunology ; Mesocricetus ; Microbiology ; Middle Aged ; Pain ; Parasitic diseases ; Plasmodium falciparum ; Plasmodium falciparum - growth & development ; Plasmodium falciparum - immunology ; Processing inhibition assay ; Protozoal diseases ; Protozoan Proteins - immunology ; Recombinant protein ; Saponins - immunology ; Sporozoites - immunology ; Vaccine ; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) ; Vaccines, Synthetic - immunology
É parte de: Vaccine, 2007-05, Vol.25 (21), p.4203-4212
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SourceType-Scholarly Journals-1
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Descrição: Abstract We report the first safety and immunogenicity trial of the Plasmodium falciparum vaccine candidate FMP2.1/AS02A, a recombinant E. coli -expressed protein based upon the apical membrane antigen-1 (AMA-1) of the 3D7 clone formulated with the AS02A adjuvant. We conducted an open-label, staggered-start, dose-escalating Phase I trial in 23 malaria-naïve volunteers who received 8, 20 or 40 μg of FMP2.1 in a fixed volume of 0.5 mL of AS02A on a 0, 1, and 2 month schedule. Nineteen of 23 volunteers received all three scheduled immunizations. The most frequent solicited local and systemic adverse events associated with immunization were injection site pain (68%) and headache (29%). There were no significant laboratory abnormalities or vaccine-related serious adverse events. All volunteers seroconverted after second immunization as determined by ELISA. Immune sera recognized sporozoites and merozoites by immunofluorescence assay (IFA), and exhibited both growth inhibition and processing inhibition activity against homologous (3D7) asexual stage parasites. Post-immunization, peripheral blood mononuculear cells exhibited FMP2.1-specific lymphoproliferation and IFN-γ and IL-5 ELISPOT assay responses. This is the first PfAMA-1-based vaccine shown to elicit both potent humoral and cellular immunity in humans. Encouraged by the potential of FMP1/AS02A to target host immunity against PfAMA-1 that is known to be expressed by sporozoite, hepatic and erythrocytic stages, we have initiated field trials of FMP2.1/AS02A in an endemic population in the Republic of Mali.
Editor: Oxford: Elsevier Ltd
Idioma: Inglês

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Phase I dose escalation safety and immunogenicity trial of Plasmodium falciparum apical membrane protein (AMA-1) FMP2.1, adjuvanted with AS02A, in malaria-naïve adults at the Walter Reed Army Institute of Research

Oxford: Elsevier Ltd

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