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Development of a Tuberculosis Vaccine in Africa
Framework programme:
Project number:
EC contribution:
€ 2 000 000
36 months
Starting date:
1 December 2002

Keywords: Tuberculosis; vaccine; infection; safety; immunogenicity. cohort


The objective of the project is to define the safety and immunogenicity of two new, virally-vectored vaccines to prevent tuberculosis (TB) in adult Africans, and to study cohorts of individuals at high risk of tuberculosis to evaluate the incidence of tuberculosis infection and disease, with the view to selecting appropriate populations and sites for future testing of TB vaccines in Africa.  

The specific objectives of the project are:

  1. to manufacture batches of the two subunit vaccines, MVA-Ag85A and FP9-Ag85A in a GMP facility to a standard required by European regulatory authorities
  2. to evaluate the safety and immunogenicity of these subunit vaccines in African volunteers without evidence of mycobacterial infection
  3. to conduct phase 1 studies of these vaccines in individuals already exposed to mycobacterial infection
  4. to test these two subunit vaccines in a heterologous prime-boost immunisation regime
  5. to measure incidence rates of TB infection and disease in cohorts of household contacts of TB cases and HIV infected individuals.

Brief description:

This three-year project will be conducted jointly in The Gambia and Senegal, using a standardised methodology. It is divided into two main parts, whose objectives are complementary and whose activities will be intertwined at the level of immunology: a phase 1 clinical trial of recombinant vaccines against TB (Work Packages 1 to 4) and the establishment of pre-vaccine cohorts (Work Packages 5 and 6). In Work Packages 1 to 3, safety and immunogenicity of the MVA and FP9 TB vaccines will be assessed in small groups of non-TB infected and in TB-infected volunteers in The Gambia. In Work Package 4, the safety and immunogenicity of these vaccines will be evaluated in prime-boost combination regimes in non-infected and infected African volunteers. In Work Packages 5 and 6, high-risk cohorts, including household contacts of TB cases and HIV-infected individuals, will be established in The Gambia and in Senegal in order to measure the incidence of TB infection and TB disease in these high-risk populations with the view to identifying suitable populations for future vaccine trials.

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