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BCG and Other Candidate Vaccines for Tuberculosis. RajKumar Kayal Guwahati. Tuberculosis: Global Burden. One third of world’s population infected with M. tuberculosis Every year, 8 million cases of infective disease 2 million die of tuberculosis every year Ranks among 10 top causes of death

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tuberculosis global burden
Tuberculosis: Global Burden
  • One third of world’s population infected with M. tuberculosis
  • Every year, 8 million cases of infective disease
  • 2 million die of tuberculosis every year
  • Ranks among 10 top causes of death
  • MDR tuberculosis
  • XDR tuberculosis
  • Declared as global emergency by WHO
bcg vaccine attenuated m bovis
BCG Vaccine: Attenuated M. bovis
  • Albert Calmette & Camille Guerin
  • 1921: 13 years & 231 generations of subcultures: launched in 1924
  • Pasteur, Tokyo, Danish, Russian, GSK, Tice etc. strains
  • Freeze dried, reconstituted in N/S, 0.1 mg in 0.1ml, I/D over L shoulder
bcg vaccine
BCG Vaccine
  • Over 100 m children vaccinated / year
  • In India, Danish strain 1331 at Guindy
  • Store with diluent in ‘Fridge, avoid exposure to sunlight
  • Reconstituted vaccine to be used within 3 hours
bcg side effects
BCG: Side Effects
  • Local Abscess
  • Regional Adenopathy +- Suppuration
  • Osteitis
  • Disseminated BCG Disease
  • Hypersensitivity reactions
  • Others: Otitis, cutaneous lesions, metastatic abscesses, renal lesions etc.
bcg side effects management
BCG Side Effects: Management
  • Local Abscess: No treatment
  • Lymphadenitis: ?Drugs, ?Surgery
  • Disseminated : ATT- pyrazinamide
  • Osteitis: Drugs + surgery
  • Anaphylaxis: Standard treatment
bcg efficacy
BCG: Efficacy
  • 80% protection against TBM & mTB
  • Overall 0-80% protection
  • Effect wanes over 10-20 years
  • Protection only in naïve subjects
  • No booster effect
  • Risk of Disease in Immunocompromised Subjects
development of new vaccines
Development of New Vaccines
  • Preclinical: Lab studies, animal models
  • Phase I: Small field study: Safety
  • Phase II: Slightly larger study: Does it induce the “right” immune response
  • Phase III: Does it protect against TB
  • License, Launch & Distribute
  • Phase IV: Post-marketing surveillance
possible types of new vaccines
Possible types of new vaccines
  • Pre-exposure
  • Post-exposure
  • Boost : early or late
  • Therapeutic
possible candidate vaccines
Possible Candidate Vaccines
  • Improved BCG
  • Attenuated M. tuberculosis
  • Adjuvanated Protein, Peptide. Or DNA subunit Vaccine
  • Virus vectored Vaccine
  • Other Approaches
improved bcg
Improved BCG
  • Expression of cytokine genes
  • Over expression of protective antigens e.g., AG85B
  • Reconstitution of deleted gene segments

To be used as pre-exposure vaccine

rBCG30, BCG:RD1, rBCG:D ure C-llo+

attenuated m tuberculosis
Attenuated M. tuberculosis
  • Targeted inactivation of metabolic genes/ virulence genes

To be used as post-exposure vaccine

adjuvanated protein peptide or dna subunit vaccine
Adjuvanated Protein, Peptide, or DNA subunit Vaccine
  • Hypothesis driven selection: secreted AG, O2 starving
  • Empirical selection: T cell recognition, MHC binding, Combination of Antigens

Early or late boost

virus vectored vaccine
Virus Vectored Vaccine
  • Modified Vaccinia Ankara Adenovirus

Early or late boost

other approaches
Other Approaches
  • Nucleocapsids
  • Killed mycobacteria e.g., M. vaccae or RUTI: as therapeutic vaccine
  • Bacteria vectored AG : Salmonella
  • Non-protein AG
  • Conjugate vaccine