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

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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:
CreatorsEmailORCIDORCID Put Code
Harrer, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Plettenberg, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Arasteh, KeikawusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Van Lunzen, JanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Faetkenheuer, GerdUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jaeger, HansUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Janssens, MichelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Burny, WivineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Collard, AlixUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Roman, FrancoisUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Loeliger, AlfredUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Koutsoukos, MargueriteUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bourguignon, PatriciaUNSPECIFIEDorcid.org/0000-0003-0398-6293UNSPECIFIED
Lavreys, LudoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Voss, GeraldUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
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:
KeywordsLanguage
CD4(+) T-CELLS; IMMUNODEFICIENCY-VIRUS TYPE-1; NK CELLS; RESPONSES; SYSTEMS; MEMORY; VOLUNTEERS; ADULTS; PROLIFERATION; INDIVIDUALSMultiple languages
Immunology; Medicine, Research & ExperimentalMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/43846

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