TB034:ChAdOx1 85A and MVA85A in BCG vaccinated adults

• Research type

  Research Study

• Full title

  A Phase I Trial to Evaluate the Safety and Immunogenicity of a ChAdOx1 85A vaccination with and without MVA85A boost in healthy BCG vaccinated adults

• IRAS ID

  122626

• Contact name

  Helen McShane

• Eudract number

  2012-005118-21

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Tuberculosis (TB) is responsible for more deaths worldwide than any other infectious disease. The Bacille Calmette-Guérin (BCG) vaccine remains the only licenced TB vaccine and while it is effective in preventing disseminated TB disease in childhood it does not protect against pulmonary TB in many parts of the world. Therefore a more effective vaccine remains an urgent global public health priority.MVA85A, developed by the University of Oxford, is one of the most advanced new candidate TB vaccines and has been shown to be highly immunogenic as a booster vaccine in BCG-primed subjects. The results of a large phase 11b efficacy trial in BCG-vaccinated infants in South Africa are expected in early 2013.ChAdOx1 85A is a new candidate TB vaccine, also developed by the University of Oxford, based on a simian adenoviral vector expressing the M. tb antigen 85A.This is a first-in-man trial for candidate ChAdOx1 85A vaccine, and based on pre-clinical experience with this vaccine in animal studies, the hypothesis is that this vaccine may increase T-cell mediated immunity and thus protection from tuberculosis. Pre-clinical and clinical studies in HIV and malaria have shown that adenovirus prime followed by MVA boost is effective at inducing high levels of immunity and protection. Safety and immunogenicity will be evaluated in two groups of BCG vaccinated adults receiving either ChAdOx1 85A alone and ChAdOx1 85A followed by a MVA85A boost. As this is a first-in-man trial for ChAdOx1 85A the first 6 volunteers will receive a low dose of this vaccine, and the remaining volunteers will receive a higher dose of vaccine post evaluation of the initial safety data.Volunteers will be followed up between and following vaccinations to assess safety and immune responses by blood sampling.This trial will take place at two sites, the CCVTM, Oxford and the WTCRF, Birmingham and financed by the Wellcome Trust.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  13/SC/0098

• Date of REC Opinion

  13 Mar 2013

• REC opinion

  Favourable Opinion