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Schema {🗺️}

WebPage:
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         headline:iHIVARNA phase IIa, a randomized, placebo-controlled, double-blinded trial to evaluate the safety and immunogenicity of iHIVARNA-01 in chronically HIV-infected patients under stable combined antiretroviral therapy
         description:HIV therapeutic vaccination aims to improve the immune responses against HIV in order to control viral replication without the need for combined antiretroviral therapy (cART). iHIVARNA-01 is a novel vaccine combining mRNA delivery and T-cell immunogen (HTI) based on conserved targets of effective antiviral T-cell responses. In addition, it holds adequate stimuli required for activating antigen presenting cells (APC)s and co-activating specific T-cells (TriMix), including human CD40L, constitutively active TLR4 (caTLR4) and CD70. We propose that in-vivo targeting of dendritic cells (DCs) by direct administration of a HIV mRNA encoding these immune modulating proteins might be an attractive alternative to target DCs in vitro. This is a phase-IIa, randomized, double-blinded, placebo-controlled, multicenter study in chronically HIV-1 infected patients under stable cART. One of the three study arms is randomly allocated to subjects. Three vaccinations with either HIVACAT T-cell immunogen (HTI)-TriMix (iHIVARNA-01), TriMix or water for injection (WFI) (weeks 0, 2 and 4) are administered by intranodal injection in the inguinal region. Two weeks after the last immunization (week 6) cART is stopped for 12 weeks. The two primary endpoints are: (1) safety and tolerability of intranodal iHIVARNA-01 vaccination compared with TriMix or WFI and (2) induced immunogenicity, i.e., increase in the frequency of HIV-specific T-cell responses between baseline, week 6 and 12 weeks after treatment interruption in iHIVARNA-01-treated patients as compared to the control groups, immunized with TriMix-mRNA or WFI measured by an IFNγ ELISPOT assay. Secondary endpoints include the evaluation of time to viral rebound, plasma viral load (pVL) at w18, the proportion of patients with control of viral load, induction of T-cell responses to new HIV epitopes, polyfunctionality of HIV-specific T-cells, CD8+ T-cell in-vitro HIV suppressive capacity, the effect on viral reservoir (measured by proviral DNA and cell-associated RNA), assessment of viral immune escape by mutation and mRNA expression profiles of host immune genes. This trial aims to direct target DC in situ with mRNA encoding HTI and TriMix for co-stimulation. Intranodal injection circumvents laborious DC isolation and handling in the laboratory. The trial extends on the safety results of a phase-I dose-escalating trial. This candidate vaccine could complement or even replace cART for chronic HIV infection and could be applicable to improve the care and cost of HIV infection. EudraCT 2016-002724-83 (22 September 2016); ClinicalTrials.gov, ID: NCT02888756. Registered on 23 August 2016.
         datePublished:2019-06-17T00:00:00Z
         dateModified:2019-12-13T00:00:00Z
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            Therapeutic vaccine
            Functional cure
            Immunotherapy
            Reservoir
            Lymph node
            TriMix
            Antigen-presenting cell
            Medicine/Public Health
            general
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            Statistics for Life Sciences
            Medicine
            Health Sciences
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ScholarlyArticle:
      headline:iHIVARNA phase IIa, a randomized, placebo-controlled, double-blinded trial to evaluate the safety and immunogenicity of iHIVARNA-01 in chronically HIV-infected patients under stable combined antiretroviral therapy
      description:HIV therapeutic vaccination aims to improve the immune responses against HIV in order to control viral replication without the need for combined antiretroviral therapy (cART). iHIVARNA-01 is a novel vaccine combining mRNA delivery and T-cell immunogen (HTI) based on conserved targets of effective antiviral T-cell responses. In addition, it holds adequate stimuli required for activating antigen presenting cells (APC)s and co-activating specific T-cells (TriMix), including human CD40L, constitutively active TLR4 (caTLR4) and CD70. We propose that in-vivo targeting of dendritic cells (DCs) by direct administration of a HIV mRNA encoding these immune modulating proteins might be an attractive alternative to target DCs in vitro. This is a phase-IIa, randomized, double-blinded, placebo-controlled, multicenter study in chronically HIV-1 infected patients under stable cART. One of the three study arms is randomly allocated to subjects. Three vaccinations with either HIVACAT T-cell immunogen (HTI)-TriMix (iHIVARNA-01), TriMix or water for injection (WFI) (weeks 0, 2 and 4) are administered by intranodal injection in the inguinal region. Two weeks after the last immunization (week 6) cART is stopped for 12 weeks. The two primary endpoints are: (1) safety and tolerability of intranodal iHIVARNA-01 vaccination compared with TriMix or WFI and (2) induced immunogenicity, i.e., increase in the frequency of HIV-specific T-cell responses between baseline, week 6 and 12 weeks after treatment interruption in iHIVARNA-01-treated patients as compared to the control groups, immunized with TriMix-mRNA or WFI measured by an IFNγ ELISPOT assay. Secondary endpoints include the evaluation of time to viral rebound, plasma viral load (pVL) at w18, the proportion of patients with control of viral load, induction of T-cell responses to new HIV epitopes, polyfunctionality of HIV-specific T-cells, CD8+ T-cell in-vitro HIV suppressive capacity, the effect on viral reservoir (measured by proviral DNA and cell-associated RNA), assessment of viral immune escape by mutation and mRNA expression profiles of host immune genes. This trial aims to direct target DC in situ with mRNA encoding HTI and TriMix for co-stimulation. Intranodal injection circumvents laborious DC isolation and handling in the laboratory. The trial extends on the safety results of a phase-I dose-escalating trial. This candidate vaccine could complement or even replace cART for chronic HIV infection and could be applicable to improve the care and cost of HIV infection. EudraCT 2016-002724-83 (22 September 2016); ClinicalTrials.gov, ID: NCT02888756. Registered on 23 August 2016.
      datePublished:2019-06-17T00:00:00Z
      dateModified:2019-12-13T00:00:00Z
      pageStart:1
      pageEnd:10
      license:http://creativecommons.org/publicdomain/zero/1.0/
      sameAs:https://doi.org/10.1186/s13063-019-3409-1
      keywords:
         HIV-1
         Therapeutic vaccine
         Functional cure
         Immunotherapy
         Reservoir
         Lymph node
         TriMix
         Antigen-presenting cell
         Medicine/Public Health
         general
         Biomedicine
         Statistics for Life Sciences
         Medicine
         Health Sciences
      image:
         https://media.springernature.com/lw1200/springer-static/image/art%3A10.1186%2Fs13063-019-3409-1/MediaObjects/13063_2019_3409_Fig1_HTML.png
         https://media.springernature.com/lw1200/springer-static/image/art%3A10.1186%2Fs13063-019-3409-1/MediaObjects/13063_2019_3409_Fig2_HTML.png
      isPartOf:
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         name:BioMed Central
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            type:ImageObject
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      author:
            name:Wesley de Jong
            url:http://orcid.org/0000-0001-9674-2647
            affiliation:
                  name:Erasmus MC
                  address:
                     name:Department of Viroscience, Erasmus MC, Rotterdam, The Netherlands
                     type:PostalAddress
                  type:Organization
            type:Person
            name:Joeri Aerts
            affiliation:
                  name:Vrije Universiteit Brussel
                  address:
                     name:Laboratory of Molecular and Cellular Therapy, Vrije Universiteit Brussel, Brussels, Belgium
                     type:PostalAddress
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            type:Person
            name:Sabine Allard
            affiliation:
                  name:Universitair Ziekenhuis Brussel
                  address:
                     name:Department of Internal Medicine and Infectious Diseases, Universitair Ziekenhuis Brussel, Brussels, Belgium
                     type:PostalAddress
                  type:Organization
            type:Person
            name:Christian Brander
            affiliation:
                  name:IrsiCaixa AIDS Research Institute, Hospital Germans Trias i Pujol
                  address:
                     name:Infectious Diseases Unit, IrsiCaixa AIDS Research Institute, Hospital Germans Trias i Pujol, Badalona, Spain
                     type:PostalAddress
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                  name:Institució Catalana de Recerca i Estudis Avançats (ICREA)
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                     type:PostalAddress
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                  name:AELIX Therapeutics, Parc Científic de Barcelona
                  address:
                     name:AELIX Therapeutics, Parc Científic de Barcelona, Barcelona, Spain
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                  name:University of Vic – Central University of Catalonia (UVic-UCC)
                  address:
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            name:Jozefien Buyze
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                     name:Infectious Diseases Unit, IrsiCaixa AIDS Research Institute, Hospital Germans Trias i Pujol, Badalona, Spain
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                  name:Erasmus MC
                  address:
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         name:Virology Unit, Department of Biomedical Sciences, Institute of Tropical Medicine and, Antwerp, Belgium
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         name:University of Vic – Central University of Catalonia (UVic-UCC), Vic, Spain
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      name:Vrije Universiteit Brussel
      address:
         name:Laboratory of Molecular and Cellular Therapy, Vrije Universiteit Brussel, Brussels, Belgium
         type:PostalAddress
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ImageObject:
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            name:Erasmus MC
            address:
               name:Department of Viroscience, Erasmus MC, Rotterdam, The Netherlands
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      name:Joeri Aerts
      affiliation:
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            address:
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      name:Sabine Allard
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               type:PostalAddress
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      affiliation:
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               type:PostalAddress
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            name:Institució Catalana de Recerca i Estudis Avançats (ICREA)
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               name:Institució Catalana de Recerca i Estudis Avançats (ICREA), Barcelona, Spain
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            name:AELIX Therapeutics, Parc Científic de Barcelona
            address:
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               type:PostalAddress
            type:Organization
            name:University of Vic – Central University of Catalonia (UVic-UCC)
            address:
               name:University of Vic – Central University of Catalonia (UVic-UCC), Vic, Spain
               type:PostalAddress
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            address:
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            address:
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               type:PostalAddress
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            name:University of Antwerp
            address:
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               type:PostalAddress
            type:Organization
      name:Eric van Gorp
      affiliation:
            name:Erasmus MC
            address:
               name:Department of Viroscience, Erasmus MC, Rotterdam, The Netherlands
               type:PostalAddress
            type:Organization
      name:Guido Vanham
      affiliation:
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            address:
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               type:PostalAddress
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            name:University of Antwerp
            address:
               name:Department of Biomedical Sciences, University of Antwerp, Antwerp, Belgium
               type:PostalAddress
            type:Organization
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      affiliation:
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            address:
               name:Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
               type:PostalAddress
            type:Organization
            name:Hospital Clínic
            address:
               name:Infectious Diseases Unit, Hospital Clínic, Barcelona, Spain
               type:PostalAddress
            type:Organization
      name:Beatriz Mothe
      affiliation:
            name:IrsiCaixa AIDS Research Institute, Hospital Germans Trias i Pujol
            address:
               name:Infectious Diseases Unit, IrsiCaixa AIDS Research Institute, Hospital Germans Trias i Pujol, Badalona, Spain
               type:PostalAddress
            type:Organization
            name:University of Vic – Central University of Catalonia (UVic-UCC)
            address:
               name:University of Vic – Central University of Catalonia (UVic-UCC), Vic, Spain
               type:PostalAddress
            type:Organization
      name:Kris Thielemans
      affiliation:
            name:Vrije Universiteit Brussel
            address:
               name:Laboratory of Molecular and Cellular Therapy, Vrije Universiteit Brussel, Brussels, Belgium
               type:PostalAddress
            type:Organization
      name:Montse Plana
      affiliation:
            name:Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)
            address:
               name:Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
               type:PostalAddress
            type:Organization
      name:Félipe Garcia
      affiliation:
            name:Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)
            address:
               name:Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
               type:PostalAddress
            type:Organization
            name:Hospital Clínic
            address:
               name:Infectious Diseases Unit, Hospital Clínic, Barcelona, Spain
               type:PostalAddress
            type:Organization
      email:[email protected]
      name:Rob Gruters
      affiliation:
            name:Erasmus MC
            address:
               name:Department of Viroscience, Erasmus MC, Rotterdam, The Netherlands
               type:PostalAddress
            type:Organization
      email:[email protected]
PostalAddress:
      name:Department of Viroscience, Erasmus MC, Rotterdam, The Netherlands
      name:Laboratory of Molecular and Cellular Therapy, Vrije Universiteit Brussel, Brussels, Belgium
      name:Department of Internal Medicine and Infectious Diseases, Universitair Ziekenhuis Brussel, Brussels, Belgium
      name:Infectious Diseases Unit, IrsiCaixa AIDS Research Institute, Hospital Germans Trias i Pujol, Badalona, Spain
      name:Institució Catalana de Recerca i Estudis Avançats (ICREA), Barcelona, Spain
      name:AELIX Therapeutics, Parc Científic de Barcelona, Barcelona, Spain
      name:University of Vic – Central University of Catalonia (UVic-UCC), Vic, Spain
      name:Virology Unit, Department of Biomedical Sciences, Institute of Tropical Medicine and, Antwerp, Belgium
      name:Department of Biomedical Sciences, University of Antwerp, Antwerp, Belgium
      name:Virology Unit, Department of Biomedical Sciences, Institute of Tropical Medicine and, Antwerp, Belgium
      name:Department of Biomedical Sciences, University of Antwerp, Antwerp, Belgium
      name:Department of Viroscience, Erasmus MC, Rotterdam, The Netherlands
      name:Virology Unit, Department of Biomedical Sciences, Institute of Tropical Medicine and, Antwerp, Belgium
      name:Department of Biomedical Sciences, University of Antwerp, Antwerp, Belgium
      name:Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
      name:Infectious Diseases Unit, Hospital Clínic, Barcelona, Spain
      name:Infectious Diseases Unit, IrsiCaixa AIDS Research Institute, Hospital Germans Trias i Pujol, Badalona, Spain
      name:University of Vic – Central University of Catalonia (UVic-UCC), Vic, Spain
      name:Laboratory of Molecular and Cellular Therapy, Vrije Universiteit Brussel, Brussels, Belgium
      name:Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
      name:Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
      name:Infectious Diseases Unit, Hospital Clínic, Barcelona, Spain
      name:Department of Viroscience, Erasmus MC, Rotterdam, The Netherlands

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