Universität zu Köln

Harrer, Thomas, Plettenberg, Andreas, Arasteh, Keikawus, Van Lunzen, Jan, Faetkenheuer, Gerd, Jaeger, Hans, Janssens, Michel, Burny, Wivine, Collard, Alix, Roman, Francois, Loeliger, Alfred, Koutsoukos, Marguerite, Bourguignon, Patricia ORCID: 0000-0003-0398-6293, Lavreys, Ludo and Voss, Gerald (2014). Safety and immunogenicity of an adjuvanted protein therapeutic HIV-1 vaccine in subjects with HIV-1 infection: A randomised placebo-controlled study. Vaccine, 32 (22). S. 2657 - 2666. OXFORD: ELSEVIER SCI LTD. ISSN 1873-2518

Full text not available from this repository.

Abstract

The human immunodeficiency virus type-1 (HIV-1) vaccine candidate F4/AS01 has previously been shown to induce potent and persistent polyfunctional CD4(+) T-cell responses in HIV-1-seronegative volunteers. This placebo-controlled study evaluated two doses of F4/AS01 1-month apart in antiretroviral treatment (ART)-experienced and ART-naive HIV-1-infected subjects (1:1 randomisation in each cohort). Safety, HIV-1-specific CD4(+) and CD8(+) T-cell responses, absolute CD4(+) T-cell counts and HIV-1 viral load were monitored for 12 months post-vaccination. Reactogenicity was clinically acceptable and no vaccinerelated serious adverse events were reported. The frequency of HIV-1-specific CD4(+) T-cells 2 weeks post-dose 2 was significantly higher in the vaccine group than in the placebo group in both cohorts (p < 0.05). Vaccine-induced HIV-1-specific CD4(+) T-cells exhibited a polyfunctional phenotype, expressing at least CD40L and IL-2. No increase in HIV-1-specific CD8(+) T-cells or change in CD8(+) T-cell activation marker expression profile was detected. Absolute CD4(+) T-cell counts were variable over time in both cohorts. Viral load remained suppressed in ART-experienced subjects. In ART-naive subjects, a transient reduction in viral load from baseline was observed 2 weeks after the second F4/AS01 dose, which was concurrent with a higher frequency of HIV-1-specific CD4(+) T-cells expressing at least IL-2 in this cohort. In conclusion, F4/AS01 showed a clinically acceptable reactogenicity and safety profile, and induced polyfunctional HIV-1-specific CD4(+) T-cell responses in ART-experienced and ART-naive subjects. These findings support further clinical investigation of F4/AS01 as a potential HIV-1 vaccine for therapeutic use in individuals with HIV-1 infection. (C) 2013 The Authors. Published by Elsevier Ltd. All rights reserved.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Harrer, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Plettenberg, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Arasteh, Keikawus UNSPECIFIED UNSPECIFIED UNSPECIFIED Van Lunzen, Jan UNSPECIFIED UNSPECIFIED UNSPECIFIED Faetkenheuer, Gerd UNSPECIFIED UNSPECIFIED UNSPECIFIED Jaeger, Hans UNSPECIFIED UNSPECIFIED UNSPECIFIED Janssens, Michel UNSPECIFIED UNSPECIFIED UNSPECIFIED Burny, Wivine UNSPECIFIED UNSPECIFIED UNSPECIFIED Collard, Alix UNSPECIFIED UNSPECIFIED UNSPECIFIED Roman, Francois UNSPECIFIED UNSPECIFIED UNSPECIFIED Loeliger, Alfred UNSPECIFIED UNSPECIFIED UNSPECIFIED Koutsoukos, Marguerite UNSPECIFIED UNSPECIFIED UNSPECIFIED Bourguignon, Patricia UNSPECIFIED orcid.org/0000-0003-0398-6293 UNSPECIFIED Lavreys, Ludo UNSPECIFIED UNSPECIFIED UNSPECIFIED Voss, Gerald UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-438463
DOI:	10.1016/j.vaccine.2013.10.030
Journal or Publication Title:	Vaccine
Volume:	32
Number:	22
Page Range:	S. 2657 - 2666
Date:	2014
Publisher:	ELSEVIER SCI LTD
Place of Publication:	OXFORD
ISSN:	1873-2518
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language CD4(+) T-CELLS; IMMUNODEFICIENCY-VIRUS TYPE-1; NK CELLS; RESPONSES; SYSTEMS; MEMORY; VOLUNTEERS; ADULTS; PROLIFERATION; INDIVIDUALS Multiple languages Immunology; Medicine, Research & Experimental Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/43846