Indigenous PCV 15 - An affordable, Asia specific Pneumococcal Conjugate Vaccine –

Current status of development

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M. Kuppusamy, Ph.D

Managing Director,Tergene Biotech Pvt. Ltd.,

Hyderabad

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Pneumococcal Conjugate Vaccine Design

Serotypes included: 15 types of pneumococcal polysaccharides

1, 2, 3, 4, 5, 6A, 6B, 7F, 9V, 12F, 14, 18C, 19A, 19F, 23F

Source of Strains:CDC, Atlanta

Carrier protein: CRM 197 Diphtheria Toxin (Non-recombinant)

Conjugation Chemistry:Cyanalation, Adipic acid linker, Carbo-di-imide cross linking

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PCV 7 PCV 10 PCV 13 PCV 15

4 4 4 4

6B 6B 6B 6B

9V 9V 9V 9V

14 14 14 14

18C 18C 18C 18C

19F 19F 19F 19F

23F 23F 23F 23F

1 1 1

5 5 5

7F 7F 7F

3 3

6A 6A

19A 19A

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12F

Vaccine Formulations

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Region PCV 7 PCV 10 PCV 13 PCV 15

North America 78 % 81 % 88 % 89 %

Europe 67 % 76 % 88 % 89 %

Latin America 53 % 72 % 82 % 83 %

Oceania 65 % 72 % 80 % 83 %

Africa 40 % 63 % 77 % 81 %

Asia 48 % 66 % 74 % 78 %

Region wise Serotype Coverage

* Pneumococcal Regional Serotype Distribution for Pneumococcal AMC TPP, 2008

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Current Status of PCV - 15

In House technology development & Proof of concept established in 2010

Production of GMP lots for pre-clinical and clinical studies under progress

Commercial launch expected in 4th quarter of 2014

Project supported by DBT, Govt. of India

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THANK YOU!