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A phase I trial evaluating the safety and immunogenicity of a candidate tuberculosis vaccination regimen, ChAdOx1 85A prime - MVA85A boost in healthy UK adults.
Wilkie, Morven; Satti, Iman; Minhinnick, Alice; Harris, Stephanie; Riste, Michael; Ramon, Raquel Lopez; Sheehan, Sharon; Thomas, Zita-Rose Manjaly; Wright, Daniel; Stockdale, Lisa; Hamidi, Ali; O'Shea, Matthew K; Dwivedi, Kritica; Behrens, Hannah Michaela; Davenne, Tamara; Morton, Joshua; Vermaak, Samantha; Lawrie, Alison; Moss, Paul; McShane, Helen.
Afiliação
  • Wilkie M; The Jenner Institute, University of Oxford, Oxford OX3 7DQ, UK.
  • Satti I; The Jenner Institute, University of Oxford, Oxford OX3 7DQ, UK.
  • Minhinnick A; The Jenner Institute, University of Oxford, Oxford OX3 7DQ, UK.
  • Harris S; The Jenner Institute, University of Oxford, Oxford OX3 7DQ, UK.
  • Riste M; The Jenner Institute, University of Oxford, Oxford OX3 7DQ, UK.
  • Ramon RL; The Jenner Institute, University of Oxford, Oxford OX3 7DQ, UK.
  • Sheehan S; The Jenner Institute, University of Oxford, Oxford OX3 7DQ, UK.
  • Thomas ZM; The Jenner Institute, University of Oxford, Oxford OX3 7DQ, UK.
  • Wright D; The Jenner Institute, University of Oxford, Oxford OX3 7DQ, UK.
  • Stockdale L; The Jenner Institute, University of Oxford, Oxford OX3 7DQ, UK.
  • Hamidi A; The Jenner Institute, University of Oxford, Oxford OX3 7DQ, UK.
  • O'Shea MK; The Jenner Institute, University of Oxford, Oxford OX3 7DQ, UK.
  • Dwivedi K; The Jenner Institute, University of Oxford, Oxford OX3 7DQ, UK.
  • Behrens HM; The Jenner Institute, University of Oxford, Oxford OX3 7DQ, UK.
  • Davenne T; The Jenner Institute, University of Oxford, Oxford OX3 7DQ, UK.
  • Morton J; The Jenner Institute, University of Oxford, Oxford OX3 7DQ, UK.
  • Vermaak S; The Jenner Institute, University of Oxford, Oxford OX3 7DQ, UK.
  • Lawrie A; The Jenner Institute, University of Oxford, Oxford OX3 7DQ, UK.
  • Moss P; Institute of Immunology and Immunotherapy, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK.
  • McShane H; The Jenner Institute, University of Oxford, Oxford OX3 7DQ, UK. Electronic address: helen.mcshane@ndm.ox.ac.uk.
Vaccine ; 38(4): 779-789, 2020 01 22.
Article em En | MEDLINE | ID: mdl-31735500
ABSTRACT

BACKGROUND:

This phase I trial evaluated the safety and immunogenicity of a candidate tuberculosis vaccination regimen, ChAdOx1 85A prime-MVA85A boost, previously demonstrated to be protective in animal studies, in healthy UK adults.

METHODS:

We enrolled 42 healthy, BCG-vaccinated adults into 4 groups low dose Starter Group (n = 6; ChAdOx1 85A alone), high dose groups; Group A (n = 12; ChAdOx1 85A), Group B (n = 12; ChAdOx1 85A prime - MVA85A boost) or Group C (n = 12; ChAdOx1 85A - ChAdOx1 85A prime - MVA85A boost). Safety was determined by collection of solicited and unsolicited vaccine-related adverse events (AEs). Immunogenicity was measured by antigen-specific ex-vivo IFN-γ ELISpot, IgG serum ELISA, and antigen-specific intracellular IFN-γ, TNF-α, IL-2 and IL-17.

RESULTS:

AEs were mostly mild/moderate, with no Serious Adverse Events. ChAdOx1 85A induced Ag85A-specific ELISpot and intracellular cytokine CD4+ and CD8+ T cell responses, which were not boosted by a second dose, but were boosted with MVA85A. Polyfunctional CD4+ T cells (IFN-γ, TNF-α and IL-2) and IFN-γ+, TNF-α+ CD8+ T cells were induced by ChAdOx1 85A and boosted by MVA85A. ChAdOx1 85A induced serum Ag85A IgG responses which were boosted by MVA85A.

CONCLUSION:

A ChAdOx1 85A prime - MVA85A boost is well tolerated and immunogenic in healthy UK adults.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Tuberculose / Vacina BCG / Vacinação / Vacinas contra a Tuberculose Tipo de estudo: Clinical_trials / Observational_studies / Prognostic_studies Limite: Adult / Humans País/Região como assunto: Europa Idioma: En Revista: Vaccine Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Reino Unido
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Tuberculose / Vacina BCG / Vacinação / Vacinas contra a Tuberculose Tipo de estudo: Clinical_trials / Observational_studies / Prognostic_studies Limite: Adult / Humans País/Região como assunto: Europa Idioma: En Revista: Vaccine Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Reino Unido