TB040: MVA85A aerosol vs IM in adults with latent M.tb infection

• Research type

  Research Study

• Full title

  A phase I trial to compare the safety and immunogenicity of candidate TB vaccine MVA85A administered by the aerosol inhaled route and the intramuscular route in healthy adult volunteers who are latently infected with Mycobacterium tuberculosis

• IRAS ID

  181214

• Contact name

  Helen McShane

• Contact email

  helen.mcshane@ndm.ox.ac.uk

• Sponsor organisation

  University of Oxford

• Eudract number

  2015-001826-41

• Duration of Study in the UK

  2 years, 0 months, 0 days

• Research summary

  TB remains a significant global health problem with a third of the world’s population being latently infected with M.tb and carrying a 10% lifetime risk of developing active life-threatening disease. There is an urgent need for a better vaccine as the only licensed vaccine, BCG, protects against severe TB in infancy but less well against lung disease, which is how TB spreads.

  As TB is spread by inhalation of infectious droplets into the lungs, it is thought that immunising directly into the lung mucosa will produce better immunity to the disease, than if the vaccine is given into the skin. Over 2500 subjects have now received MVA85A, 48 by the intramuscular route, 12 by the aerosol route and the remainder intradermally.

  The first clinical trial of MVA85A delivered by aerosol to humans was our trial
  TB026, in which 12 volunteers received aerosolised MVA85A (10 received the low dose 1 x 10^7 pfu, and 2 received the higher dose 1 x 10^8 pfu). In this trial the aerosol immunisation was well tolerated. A second Phase I safety trial assessing anti-vector immunity with aerosolised MVA85A is currently ongoing, testing an intermediate dose of 5 x 10^7 pfu (TB035). Aerosol delivery of MVA85A vaccine therefore shows promise; however, before this route of administration can be used in TB high burden countries, it is important that its safety in subjects with latent M.tb infection is determined. This is because of the theoretical risk of a vaccine related inflammatory response in the lungs of individuals with latent M.tb infection.

  This trial aims to assess safety and immunogenicity of aerosol MVA85A vaccination in healthy UK adult volunteers with latent M.tb infection.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  15/SC/0370

• Date of REC Opinion

  14 Jul 2015

• REC opinion

  Favourable Opinion