TB032: AERAS-402 and MVA85A in BCG vaccinated adults
Research type
Research Study
Full title
A Phase I, Open Label Trial to Evaluate the Safety and Immunogenicity of AERAS-402 followed by MVA85A in BCG vaccinated adults
IRAS ID
106819
Contact name
Helen McShane
Sponsor organisation
Clinical Trials and Research Governance
Eudract number
2012-002007-18
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
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 candidates in this field are: vaccine MVA85A, developed by the University of Oxford, and currently being tested in a BCG prime MVA85A boost regimen in two large phase IIb efficacy trials, the first in infants in South Africa, and the second in HIV-infected adults in South Africa and Senegal, and; vaccine AERAS-402 developed by Crucell and currently being tested in a large phase IIb multi-site efficacy trial in Africa. Both vaccines induce cellular immune responses thought to be important in protection from TB. In this trial both vaccines will be evaluated together for the first time. Safety and immunogenicity will be evaluated in three groups of BCG vaccinated adults receiving either one or two doses of AERAS-402 followed by MVA85A, or three consecutive doses of AERAS-402. The hypothesis is that both vaccines will have an acceptable safety profile and that the additive immunogenicity of both vaccines will exceed their individual immunogenicities. Volunteers will be followed up between and following vaccinations to assess safety and also immune responses by blood sampling.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
12/SC/0283
Date of REC Opinion
20 Jun 2012
REC opinion
Favourable Opinion