established in late 1999 scientific/clinical resources ethics committees regulatory body

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Established in late 1999 •Scientific/clinical resources •Ethics committees •Regulatory body TT - 2002

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Established in late 1999 Scientific/clinical resources Ethics committees Regulatory body. TT - 2002. SAAVI aims to develop an affordable , effective and locally relevant preventative HIV vaccine for southern Africa. G. G. J. J. AE. G. AE. H. AE. AG. AG. B. B. B. AG. B. B. - PowerPoint PPT Presentation

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Page 1: Established in late 1999 Scientific/clinical resources Ethics committees Regulatory body

Established in late 1999

• Scientific/clinical resources

• Ethics committees

• Regulatory bodyTT - 2002

Page 2: Established in late 1999 Scientific/clinical resources Ethics committees Regulatory body

SAAVI aims to develop an affordable, effective and locally relevant preventative HIV vaccine for southern

Africa

Page 3: Established in late 1999 Scientific/clinical resources Ethics committees Regulatory body

HIV genetic diversityHIV genetic diversity

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C. Williamson et al

Page 4: Established in late 1999 Scientific/clinical resources Ethics committees Regulatory body

Making the vaccine

Testing the vaccine

Ethicalissues

Advocacy& community

Others

TT - 2002

Immunologyassessment

Human Animal

Page 5: Established in late 1999 Scientific/clinical resources Ethics committees Regulatory body

What do we expect from What do we expect from an HIV vaccine?an HIV vaccine?

Page 6: Established in late 1999 Scientific/clinical resources Ethics committees Regulatory body

““Viral load” in HIVViral load” in HIV

Am

o un t

of H

I V

5%

90%

Progress toAIDS in 5 years

Page 7: Established in late 1999 Scientific/clinical resources Ethics committees Regulatory body

Potential end-points of HIV-Potential end-points of HIV-vaccine efficacy trialsvaccine efficacy trials

Page 8: Established in late 1999 Scientific/clinical resources Ethics committees Regulatory body

TT - 2002

SAAVI ChallengesSAAVI Challenges

Page 9: Established in late 1999 Scientific/clinical resources Ethics committees Regulatory body

Making the vaccine

Testing the vaccine

Ethicalissues

Advocacy& community

Others

TT - 2002

Immunologyassessment

Human Animal

Page 10: Established in late 1999 Scientific/clinical resources Ethics committees Regulatory body

TT - 2002

Supporters and Funds

Source TOTAL 2001 TOTAL 2002Department of Health R 5,000,000 R 10,000,000Department of Arts, Culture, Science and TechnologyR 10,000,000 R 10,000,000Eskom R 7,500,000 R 15,000,000HIV Vaccine Trial Network R 7,000,000 R 8,000,000NIH Vaccine Development Research Committee (VDRG) R 0 R 18,000,000European Union R 5,000,000 R 5,000,000Corporation A R 10,000,000

TOTAL R 34,500,000 R 76,000,000

Page 11: Established in late 1999 Scientific/clinical resources Ethics committees Regulatory body

TT - 2002

1. Good vaccine candidates

2. HIV subtypes

3. Community involvement

4. Ethical studies

5. Access to product

6. Pricing

7. Technology transfer

Appropriate Clinical Trials

$30

mill

ion

Page 12: Established in late 1999 Scientific/clinical resources Ethics committees Regulatory body

TT - 2002

Manufacturing 1. Product?

2. When?

3. What dose?

4. Manufacturing plant

5. Personnel

6. Dose price

7. Distribution capacity

$350

milli

on

•Clinical trials lot

•Bulk supply

Page 13: Established in late 1999 Scientific/clinical resources Ethics committees Regulatory body

TT - 2002

1. Government

2. Medicines Control Council

3. Ethics committees

4. Medical aids

5. Life Insurance

6. Blood transfusion services

7. State Vaccine Institute

Strategic nationalalliances

Page 14: Established in late 1999 Scientific/clinical resources Ethics committees Regulatory body

TT - 2002

Strategic international alliances

1. NIH

2. HVTN

3. IAVI

4. AAVP

5. EU

6. Public / private

Page 15: Established in late 1999 Scientific/clinical resources Ethics committees Regulatory body

CONCLUSIONSCONCLUSIONS

• SAAVI has dynamic team

• Different to all other initiatives

• Committed to excellence

• Massive / maturing challenges

• Consolidate and expand

TT - 2002