TB026: MVA85A by the aerosol inhaled route

• 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 intradermal route in healthy BCG-vaccinated adult subjects

• IRAS ID

  64801

• Contact name

  Helen McShane

• Eudract number

  2010-022381-27

• ISRCTN Number

  n/a

• Research summary

  Tuberculosis (TB) is responsible for more deaths worldwide than any other infectious disease. The currently used TB vaccine, BCG (Bacille Calmette-GuǸrin), is not effective enough at preventing infection in many parts of the world. Therefore a more universally effective vaccine is urgently needed. The most advanced new candidate in this field is vaccine MVA85A, developed by the University of Oxford, and currently being tested in a BCG-prime MVA85A-boost regimen in a large phase IIb efficacy trial in infants in South Africa. This novel vaccine has so far been safely given by the standard intradermal route to over 1550 individuals. In this study we will investigate giving the same vaccine by a different route, the aerosol inhaled route. This means that an inhaler or nebuliser device is used to turn the vaccine liquid into a very fine mist (aerosol) which can be breathed in (inhaled). Some vaccines including the measles vaccine have already been widely evaluated by this route. We know that the lungs have a very well developed and specialised immune system. We also know that Mycobacterium tuberculosis, the bacterium that causes TB, commonly infects people by being breathed into the lungs, where much of the damage occurs. Additionally this route would remove the need for needles and injections, is easy to perform even by yourself, is well tolerated by adults and children, and is cost effective. In this trial we will evaluate the safety and immune responses induced by the new inhaled route as compared to the standard intradermal route in two groups of twelve previously BCG-vaccinated adults. Volunteers will undergo a bronchoscopy as part of the trial. This is a routine medical procedure performed under light sedation whereby a thin flexible telescope is passed into the lungs to examine them and obtain samples.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  11/SC/0021

• Date of REC Opinion

  30 Mar 2011

• REC opinion

  Further Information Favourable Opinion