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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
immunology and microbiology
Safety and enhanced immunogenicity of a hepatitis B core particle Plasmodium falciparum malaria vaccine formulated in adjuvant Montanide ISA 720 in a phase I trial
Infection and Immunity, Volume 73, No. 6, Year 2005
Notification
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Description
Highly purified subunit vaccines require potent adjuvants in order to elicit optimal immune responses. In a previous phase I trial, an alum formulation of ICC-1132, a malaria vaccine candidate comprising hepatitis B core (HBc) virus-like particle containing Plasmodium falciparum circumsporozoite (CS) protein epitopes, was shown to elicit Plasmodium falciparum-specific antibody and cellular responses. The present study was designed as a single-blind, escalating-dose phase I trial to evaluate the safety and immunogenicity of single intramuscular doses of ICC-1132 formulated in the more potent water-in-oil adjuvant Montanide ISA 720 (ICC-1132/ ISA 720). The vaccine was safe and well tolerated, with transient injection site pain as the most frequent complaint. All vaccinees that received either 20 μg or 50 μg of ICC-1132/ISA 720 developed antiimmunogen and anti-HBc antibodies. The majority of volunteers in these two groups developed sporozoite-specific antibodies, predominantly of opsonizing immunoglobulin G subtypes. Peak titers and persistence of parasite-specific antibody following a single injection of the ISA 720 formulated vaccine were comparable to those obtained following two to three immunizations with alum-adsorbed ICC-1132. Peripheral blood mononuclear cells of ICC-1132/ISA 720 vaccinees proliferated and released cytokines (interleukin 2 and gamma interferon) when stimulated with recombinant P. falciparum CS protein, and CS-specific CD4+ T-cell lines were established from volunteers with high levels of antibodies to the repeat region. The promising results obtained with a single dose of ICC-1132 formulated in Montanide ISA 720 encourage further clinical development of this malaria vaccine candidate. Copyright © 2005, American Society for Microbiology. All Rights Reserved.
Authors & Co-Authors
Nussenzweig, Ruth Sonntag
United States, New York
Nyu Grossman School of Medicine
Birkett, Ashley J.
Unknown Affiliation
Dubovsky, Filip
Unknown Affiliation
Tierney, Eveline Lee
Unknown Affiliation
Gleiter, Christoph H.
Germany, Tubingen
Universitätsklinikum Und Medizinische Fakultät Tübingen
Luty, A. J.F.
Germany, Tubingen
Eberhard Karls Universität Tübingen
Ramharter, Michael
Germany, Tubingen
Eberhard Karls Universität Tübingen
Kremsner, Peter G.
Germany, Tubingen
Eberhard Karls Universität Tübingen
Nardin, Elizabeth Higgins
United States, New York
Nyu Grossman School of Medicine
Statistics
Citations: 101
Authors: 9
Affiliations: 4
Identifiers
Doi:
10.1128/IAI.73.6.3587-3597.2005
ISSN:
00199567
Research Areas
Disability
Environmental
Infectious Diseases