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Safety and immunogenicity of investigational tuberculosis vaccine M72/AS01E-4 in people living with HIV in South Africa: an observer-blinded, randomised, controlled, phase 2 trial.

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Title: Safety and immunogenicity of investigational tuberculosis vaccine M72/AS01E-4 in people living with HIV in South Africa: an observer-blinded, randomised, controlled, phase 2 trial.
Authors: Dagnew AF; Gates Medical Research Institute, Clinical Development, Cambridge, MA, USA. Electronic address: alemnew.dagnew@gatesmri.org., Han LL; Gates Medical Research Institute, Clinical Development, Cambridge, MA, USA., Naidoo K; CAPRISA-South African Medical Research Council (SAMRC) TB-HIV Pathogenesis and Treatment Research Unit, University of KwaZulu-Natal Nelson R Mandela School of Medicine, Durban, South Africa., Fairlie L; Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa., Innes JC; The Aurum Institute, Clinical Research Division, Aurum Klerksdorp Clinical Research, Klerksdorp, South Africa., Middelkoop K; Desmond Tutu HIV Center, Institute of Infectious Disease and Molecular Medicine, Department of Medicine, University of Cape Town, Cape Town, South Africa., Tameris M; South African Tuberculosis Vaccine Initiative (SATVI), Department of Pathology and Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa., Wilkinson RJ; Wellcome Discovery Research Platforms in Infection, Center for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine and Department of Medicine, University of Cape Town, Cape Town, South Africa; Francis Crick Institute, London, UK; Department of Infectious Diseases, Imperial College London, London, UK., Ananworanich J; Gates Medical Research Institute, Clinical Development, Cambridge, MA, USA., Bower D; Gates Medical Research Institute, Clinical Development, Cambridge, MA, USA., Schlehuber L; Gates Medical Research Institute, Clinical Development, Cambridge, MA, USA., Frahm N; Gates Medical Research Institute, Clinical Development, Cambridge, MA, USA., Cinar A; Gates Medical Research Institute, Clinical Development, Cambridge, MA, USA., Dunne M; Gates Medical Research Institute, Clinical Development, Cambridge, MA, USA., Schmidt AC; Gates Medical Research Institute, Clinical Development, Cambridge, MA, USA.
Source: The lancet. HIV [Lancet HIV] 2025 Aug; Vol. 12 (8), pp. e546-e555. Date of Electronic Publication: 2025 Jul 01.
Publication Type: Journal Article; Clinical Trial, Phase II; Randomized Controlled Trial
Journal Info: Publisher: Elsevier B.V Country of Publication: Netherlands NLM ID: 101645355 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2352-3018 (Electronic) Linking ISSN: 23523018 NLM ISO Abbreviation: Lancet HIV Subsets: MEDLINE
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  Data: Safety and immunogenicity of investigational tuberculosis vaccine M72/AS01<subscript>E-4</subscript> in people living with HIV in South Africa: an observer-blinded, randomised, controlled, phase 2 trial.
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  Data: <searchLink fieldCode="AU" term="%22Dagnew+AF%22">Dagnew AF</searchLink>; Gates Medical Research Institute, Clinical Development, Cambridge, MA, USA. Electronic address: alemnew.dagnew@gatesmri.org.<br /><searchLink fieldCode="AU" term="%22Han+LL%22">Han LL</searchLink>; Gates Medical Research Institute, Clinical Development, Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22Naidoo+K%22">Naidoo K</searchLink>; CAPRISA-South African Medical Research Council (SAMRC) TB-HIV Pathogenesis and Treatment Research Unit, University of KwaZulu-Natal Nelson R Mandela School of Medicine, Durban, South Africa.<br /><searchLink fieldCode="AU" term="%22Fairlie+L%22">Fairlie L</searchLink>; Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.<br /><searchLink fieldCode="AU" term="%22Innes+JC%22">Innes JC</searchLink>; The Aurum Institute, Clinical Research Division, Aurum Klerksdorp Clinical Research, Klerksdorp, South Africa.<br /><searchLink fieldCode="AU" term="%22Middelkoop+K%22">Middelkoop K</searchLink>; Desmond Tutu HIV Center, Institute of Infectious Disease and Molecular Medicine, Department of Medicine, University of Cape Town, Cape Town, South Africa.<br /><searchLink fieldCode="AU" term="%22Tameris+M%22">Tameris M</searchLink>; South African Tuberculosis Vaccine Initiative (SATVI), Department of Pathology and Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.<br /><searchLink fieldCode="AU" term="%22Wilkinson+RJ%22">Wilkinson RJ</searchLink>; Wellcome Discovery Research Platforms in Infection, Center for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine and Department of Medicine, University of Cape Town, Cape Town, South Africa; Francis Crick Institute, London, UK; Department of Infectious Diseases, Imperial College London, London, UK.<br /><searchLink fieldCode="AU" term="%22Ananworanich+J%22">Ananworanich J</searchLink>; Gates Medical Research Institute, Clinical Development, Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22Bower+D%22">Bower D</searchLink>; Gates Medical Research Institute, Clinical Development, Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22Schlehuber+L%22">Schlehuber L</searchLink>; Gates Medical Research Institute, Clinical Development, Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22Frahm+N%22">Frahm N</searchLink>; Gates Medical Research Institute, Clinical Development, Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22Cinar+A%22">Cinar A</searchLink>; Gates Medical Research Institute, Clinical Development, Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22Dunne+M%22">Dunne M</searchLink>; Gates Medical Research Institute, Clinical Development, Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22Schmidt+AC%22">Schmidt AC</searchLink>; Gates Medical Research Institute, Clinical Development, Cambridge, MA, USA.
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  Data: <searchLink fieldCode="JN" term="%22101645355%22">The lancet. HIV</searchLink> [Lancet HIV] 2025 Aug; Vol. 12 (8), pp. e546-e555. <i>Date of Electronic Publication: </i>2025 Jul 01.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Elsevier+B%2EV%22">Elsevier B.V </searchLink><i>Country of Publication: </i>Netherlands <i>NLM ID: </i>101645355 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>2352-3018 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2223523018%22">23523018 </searchLink><i>NLM ISO Abbreviation: </i>Lancet HIV <i>Subsets: </i>MEDLINE
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              Text: 2025 Aug
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