Tuberculosis Vaccine – Product Candidate
Tuberculosis, or TB, is an infection with Mycobacterium tuberculosis, which manifests primarily as an
illness of the respiratory system and is spread by coughing, sneezing and associated respiratory actions.
According to the WHO, TB is the world’s second leading cause of death from infectious disease in adults, after
HIV/AIDS.
Approximately 2 billion people were infected with Mycobacterium tuberculosis worldwide in 2005, one third of the world’s
population. One of ten people infected will develop the active form of the disease during their lifetime. A majority of TB cases
occur in individuals between the ages of 25 to 54 years old. Between 1.6 and 2 million die annually worldwide with more than 8
million new cases developing each year. The economic impact of TB in high-disease burden countries is significant. BCG, introduced
in 1921, is currently the only available vaccine against tuberculosis.
Our tuberculosis vaccine candidate uses the attenuated Modified Vaccinia virus Ankara, or MVA, as a vaccine delivery
platform to present antigen 85A to the immune system. Antigen 85A is a major antigen from Mycobacterium tuberculosis,
which forms part of the antigen 85 complex. Antigen 85A is highly conserved among all mycobacterial species and is present
in all strains of BCG, suggesting that antigen 85A may elicit a strong immune response in individuals previously vaccinated
with BCG. The vector, or carrier, MVA is a weakened strain of the smallpox vaccine and a highly attenuated strain of Vaccinia
virus which does not replicate in mammalian cells. Another strain of MVA has been administered to more than 120,000 individuals
as part of the smallpox eradication program and was found in that program to be safe and well tolerated, despite the deliberate
vaccination of high risk groups. Our tuberculosis vaccine has been designed to increase the immune response and protective efficacy
in individuals previously vaccinated with BCG. The clinical development of MVA85A is aimed towards the production of an effective TB
vaccine for infants, adolescents and HIV-infected individuals to augment the immunity induced by a previous BCG vaccination. The
Oxford-Emergent Tuberculosis Consortium “OETC”, a joint venture between the University of Oxford and Emergent BioSolutions, holds an
exclusive license to the vaccine. Emergent has been granted the commercial rights to MVA85A from the OETC.
Emergent BioSolutions and the University of Oxford Form Joint Venture to Develop an Advanced Tuberculosis Vaccine with Funding from Wellcome Trust and Aeras Global TB Vaccine Foundation
New TB Vaccine Candidate Enters Phase IIb Proof-of-Concept Trial in South Africa
Oxford-Emergent Tuberculosis Consortium Signs Commercial License Agreement with Vivalis to Explore Production Of MVA85A TB Vaccine Candidate Using EB66(R) Cell Line
Oxford-Emergent Tuberculosis Consortium Signs Commercial License Agreement With ProBioGen To Explore Production Of MVA85A TB Vaccine Candidate Using AGE1.CR.pIX(R) Cell Line
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Target Indication
• Prevention of tuberculosis in humans
Potential Market
• Infant, adolescent, adult and HIV-infected populations immunized with Bacille
Calmette-Guerin (BCG) vaccine
Target Product
Characteristics
• Single-dose recombinant live attenuated MVA vectored vaccine administered
to individuals who have previously been immunized with Bacille Calmette-Guerin (BCG) vaccine
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