Accelerating research and development of new vaccines against tuberculosis: a global roadmap.

Autor:	Cobelens F; Department of Global Health and Amsterdam Institute for Global Health and Development, Amsterdam University Medical Centers, Amsterdam, Netherlands. Electronic address: f.g.cobelens@amsterdamumc.nl., Suri RK; Department of Governance and Strategy, Developing Countries Vaccine Manufacturers' Network International, Nyon, Switzerland., Helinski M; European & Developing Countries Clinical Trials Partnership, The Hague, Netherlands., Makanga M; European & Developing Countries Clinical Trials Partnership, The Hague, Netherlands., Weinberg AL; European & Developing Countries Clinical Trials Partnership, The Hague, Netherlands., Schaffmeister B; Nextco, Oegstgeest, Netherlands., Deege F; Nextco, Oegstgeest, Netherlands., Hatherill M; South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine, and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.
Jazyk:	angličtina
Zdroj:	The Lancet. Infectious diseases [Lancet Infect Dis] 2022 Apr; Vol. 22 (4), pp. e108-e120. Date of Electronic Publication: 2022 Feb 28.
DOI:	10.1016/S1473-3099(21)00810-0
Abstrakt:	To eliminate tuberculosis globally, a new, effective, and affordable vaccine is urgently needed, particularly for use in adults and adolescents in low-income and middle-income countries. We have created a roadmap that lists the actions needed to accelerate tuberculosis vaccine research and development using a participatory process. The vaccine pipeline needs more diverse immunological approaches, antigens, and platforms. Clinical development can be accelerated by validated preclinical models, agreed laboratory correlates of protection, efficient trial designs, and validated endpoints. Determining the public health impact of new tuberculosis vaccines requires understanding of a country's demand for a new tuberculosis vaccine, how to integrate vaccine implementation with ongoing tuberculosis prevention efforts, cost, and national and global demand to stimulate vaccine production. Investments in tuberculosis vaccine research and development need to be increased, with more diversity of funding sources and coordination between these funders. Open science is important to enhance the efficiency of tuberculosis vaccine research and development including early and freely available publication of study findings and effective mechanisms for sharing datasets and specimens. There is a need for increased engagement of industry vaccine developers, for increased political commitment for new tuberculosis vaccines, and to address stigma and vaccine hesitancy. The unprecedented speed by which COVID-19 vaccines have been developed and introduced provides important insight for tuberculosis vaccine research and development. Competing Interests: Declaration of interests FC received funding from the European & Developing Countries Clinical Trials Partnership (EDCTP) for the present work, holds research grants from EDCTP and the Bill & Melinda Gates Foundation, reports travel support from the Tuberculosis Vaccine Initiative (TBVI) and the Coalition for TB Vaccine Discovery, and is an advisory board member of TBVI. MHe, MM, and ALW are employees of EDCTP. BS and FD received funding from EDCTP for the present work. MHa holds institutional clinical trial grants to University of Cape Town, Cape Town, South Africa, and is an advisory board member of TBVI. Tuberculosis Vaccine Roadmap Stakeholder Group: AMG reports travel support from the International AIDS Vaccine Initiative (IAVI). GBG is employed by Sanofi Pasteur and reports stocks or stock options in Sanofi Pasteur. SHEK is coinventor of the tuberculosis vaccine VPM1002, which is licensed to Vakzine Projekt Management, Hannover, Germany, and sublicensed to Serum Institute of India, Pune, India, and is co-holder of a patent licensed to Serum Institute of India. RVL received funding from EDCTP for the present work. DML received travel support from the Stop TB Partnership. CM holds clinical trial grants from EDCTP, received travel support from EDCTP, and is co-inventor on a patent on a tuberculosis vaccine held by the University of Zaragoza. RM received support for the present work from the Statens Serum Institut, holds research grants from the US National Institutes of Health (NIH) and the Independent Research Fund Denmark, and is co-inventor on a patent application on a new tuberculosis vaccine candidate. EN holds research grants from the NIH and the the Bill & Melinda Gates Foundation. THMO holds research grants from the NIH, the European Commission, and the Netherlands Organization for Research. TRS and AS are employed by the Gates Medical Research Institute. DRT is employed by IAVI. GV reports stocks or stock options in GSK. RW holds research grants from the the Bill & Melinda Gates Foundation, the Wellcome Trust, WHO, and UK Research and Innovation. The other authors declare no competing interests. The development of the Roadmap was financially supported by EDCTP. (Copyright © 2022 Elsevier Ltd. All rights reserved.)
Databáze:	MEDLINE
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