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Vaccines
Volume 9
Issue 4
10.3390/vaccines9040396
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Article

Phase I Trial Evaluating the Safety and Immunogenicity of Candidate TB Vaccine MVA85A, Delivered by Aerosol to Healthy M.tb-Infected Adults

by
Michael Riste
1,2,†,
Julia L. Marshall
1,†,
Iman Satti
1,
Stephanie A. Harris
1,
Morven Wilkie
1,
Raquel Lopez Ramon
1,
Danny Wright
1,
Rachel E. Wittenberg
1,
Samantha Vermaak
1,
Rebecca Powell Doherty
1,
Alison Lawrie
1,
Christopher P. Conlon
3,
Catherine Cosgrove
4,
Fergus Gleeson
5,
Marc Lipman
6,7,
Paul Moss
8,
Felicity Perrin
9,
Martin Dedicoat
2,
Henry Bettinson
10 and
Helen McShane
1,*
1
The Jenner Institute, University of Oxford, Oxford OX3 7DQ, UK
2
Department of Infection and Tropical Medicine, Heartlands Hospital, Birmingham B9 5SS, UK
3
Nuffield Department of Medicine, University of Oxford, Oxford OX3 7DQ, UK
4
TB Chest Clinic, St George’s University Hospitals NHS Foundation Trust, London SW15 5PN, UK
5
Department of Oncology, University of Oxford, Oxford OX3 7DQ, UK
6
Royal Free London NHS Foundation Trust, London NW3 2QG, UK
7
UCL Respiratory, University College London, London NW3 2PF, UK
8
Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham B15 2TT, UK
9
Respiratory Medicine, King’s College Hospital NHS Foundation Trust, London SE5 9PJ, UK
10
Oxford Centre for Respiratory Medicine, Oxford University Hospitals NHS Trust, Oxford OX3 7LE, UK
*
Author to whom correspondence should be addressed.
†
Joint first author.
Academic Editor: Bernat Pérez de Val
Vaccines 2021, 9(4), 396; https://doi.org/10.3390/vaccines9040396
Received: 10 March 2021 / Revised: 12 April 2021 / Accepted: 12 April 2021 / Published: 16 April 2021
(This article belongs to the Special Issue Development of Vaccines against Tuberculosis: One Health Approach)
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Abstract

The immunogenicity of the candidate tuberculosis (TB) vaccine MVA85A may be enhanced by aerosol delivery. Intradermal administration was shown to be safe in adults with latent TB infection (LTBI), but data are lacking for aerosol-delivered candidate TB vaccines in this population. We carried out a Phase I trial to evaluate the safety and immunogenicity of MVA85A delivered by aerosol in UK adults with LTBI (NCT02532036). Two volunteers were recruited, and the vaccine was well-tolerated with no safety concerns. Aerosolised vaccination with MVA85A induced mycobacterium- and vector-specific IFN-γ in blood and mycobacterium-specific Th1 cytokines in bronchoalveolar lavage. We identified several important barriers that could hamper recruitment into clinical trials in this patient population. The trial did not show any safety concerns in the aerosol delivery of a candidate viral-vectored TB vaccine to two UK adults with Mycobacterium tuberculosis (M.tb) infection. It also systemically and mucosally demonstrated inducible immune responses following aerosol vaccination. A further trial in a country with higher incidence of LTBI would confirm these findings. View Full-Text
Keywords: aerosol vaccine; MVA85A; mycobacteria; latent TB infection aerosol vaccine; MVA85A; mycobacteria; latent TB infection
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MDPI and ACS Style

Riste, M.; Marshall, J.L.; Satti, I.; Harris, S.A.; Wilkie, M.; Lopez Ramon, R.; Wright, D.; Wittenberg, R.E.; Vermaak, S.; Powell Doherty, R.; Lawrie, A.; Conlon, C.P.; Cosgrove, C.; Gleeson, F.; Lipman, M.; Moss, P.; Perrin, F.; Dedicoat, M.; Bettinson, H.; McShane, H. Phase I Trial Evaluating the Safety and Immunogenicity of Candidate TB Vaccine MVA85A, Delivered by Aerosol to Healthy M.tb-Infected Adults. Vaccines 2021, 9, 396. https://doi.org/10.3390/vaccines9040396

AMA Style

Riste M, Marshall JL, Satti I, Harris SA, Wilkie M, Lopez Ramon R, Wright D, Wittenberg RE, Vermaak S, Powell Doherty R, Lawrie A, Conlon CP, Cosgrove C, Gleeson F, Lipman M, Moss P, Perrin F, Dedicoat M, Bettinson H, McShane H. Phase I Trial Evaluating the Safety and Immunogenicity of Candidate TB Vaccine MVA85A, Delivered by Aerosol to Healthy M.tb-Infected Adults. Vaccines. 2021; 9(4):396. https://doi.org/10.3390/vaccines9040396

Chicago/Turabian Style

Riste, Michael, Julia L. Marshall, Iman Satti, Stephanie A. Harris, Morven Wilkie, Raquel Lopez Ramon, Danny Wright, Rachel E. Wittenberg, Samantha Vermaak, Rebecca Powell Doherty, Alison Lawrie, Christopher P. Conlon, Catherine Cosgrove, Fergus Gleeson, Marc Lipman, Paul Moss, Felicity Perrin, Martin Dedicoat, Henry Bettinson, and Helen McShane. 2021. "Phase I Trial Evaluating the Safety and Immunogenicity of Candidate TB Vaccine MVA85A, Delivered by Aerosol to Healthy M.tb-Infected Adults" Vaccines 9, no. 4: 396. https://doi.org/10.3390/vaccines9040396

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