Pesquisa em Vacina Anti-HIV: Questões Éticas e Regulatórias

Apresentação em tema: "Pesquisa em Vacina Anti-HIV: Questões Éticas e Regulatórias"— Transcrição da apresentação:

1 Pesquisa em Vacina Anti-HIV: Questões Éticas e Regulatórias
Experiências Nacionais e Desafios no Desenvolvimento de Novas Tecnologias Preventivas e Terapêuticas Celio L Silva Brasília, Outubro 2006

2 Immune potentiators or immune regulators
Modern vaccines Antigens Immune potentiators or immune regulators (Adjuvants) Academy Regulation Delivery systems Quality Control Scalle up Company Pre-clinical and clinical studies Profilactic or therapeutic vaccine efficacy

3 Immune potentiators or immune regulators
NBR ISO IEC 17025 Modern vaccines Antigens Immune potentiators or immune regulators (Adjuvants) Academy Regulation Delivery systems Quality Control Scalle up Company Pre-clinical and clinical studies Profilactic or therapeutic vaccine efficacy

4 Institutional organization
Academy (REDE TB and CPT) Platforms for R&D&I Infrastructure Human resources Technological capabilities Regulation Company (Farmacore) NBR ISO IEC 17025 Technological platform for R&D&I

5 Immune potentiators or immune regulators
NBR ISO IEC 17025 Modern vaccines Antigens Immune potentiators or immune regulators (Adjuvants) Academy Regulation Delivery systems Quality Control Scalle up Company Pre-clinical and clinical studies Profilactic or therapeutic vaccine efficacy

6 Immuno modulators or imuno potentiators
NBR ISO IEC 17025 ADJUVANTS Th2 Humoral I.R. Th1 Cellular I.R. Heat Shock Proteins (HSPs) CpGs ODN TDM KLK Liposomes Water-in-oil emulsion Immuno modulators or imuno potentiators

7 Nature Reviews Immunology 2002
NBR ISO IEC 17025 HSPs-Peptide complex PEPTIDE Tumoral Viral Bacterial Fúngal HSP Protection against Cancer Infectious diseases Nature Reviews Immunology 2002

8 Viral peptides chaperoned by Heat Shock Proteins (HSPs)
NBR ISO IEC 17025 Viral peptides chaperoned by Heat Shock Proteins (HSPs) hsp65 DNAhsp65 Therapeutical vaccine Immunological mediators Phase I/II clinical trial of DNAhsp65 in patients coinfected with HIV/TB, especially those in advanced immunodeficiency status and non-responsive to antiretroviral regimens Evaluate the ability of DCs pulsated with inactivated virus and stimulated with DNAhsp65 to enhance specific and unspecific anti-HIV immune response.

9 Immune potentiators or immune regulators
NBR ISO IEC 17025 Modern vaccines Antigens Immune potentiators or immune regulators (Adjuvants) Academy Regulation Delivery systems Quality Control Scalle up Company Pre-clinical and clinical studies Profilactic or therapeutic vaccine efficacy

10 NBR ISO IEC 17025 Delivery systems

11 DNA vaccine: gD-p24(Gag) DNA vaccine: p24(Gag)-hsp65
NBR ISO IEC 17025 Liposomes SUV LUV MLV SUV 25 – 100 nm 20 nm – 3m DNA vaccine: gD-p24(Gag) DNA vaccine: p24(Gag)-hsp65 Mucosal administration

12 Single dose vaccines using “prime – boost” concept
NBR ISO IEC 17025 Single dose vaccines using “prime – boost” concept PRIME BOOSTER Fast release - days Slow release – weeks to months DNAgD-p24(Gag) recombinant Protein p24 100% 75% 50% 25% DNAgD-p24(Gag) DNA rp24(Gag) Protein days Prime Booster

13 Immune potentiators or immune regulators
NBR ISO IEC 17025 Modern vaccines Antigens Immune potentiators or immune regulators (Adjuvants) Academy Regulation Delivery systems Quality Control Scalle up Company Pre-clinical and clinical studies Profilactic or therapeutic vaccine efficacy

14 Production of pilot lots in GMP conditions Downstream Upstream
NBR ISO IEC 17025 Production of pilot lots in GMP conditions Downstream Upstream DNAhsp65 and rhsp65 produced in GMP

15 Production of Delivery Systems in GLP conditions
NBR ISO IEC 17025 Production of Delivery Systems in GLP conditions PLGA microspheres Liposomes

16 Immune potentiators or immune regulators
NBR ISO IEC 17025 Modern vaccines Antigens Immune potentiators or immune regulators (Adjuvants) Academy Regulation Delivery systems Quality Control Scalle up Company Pre-clinical and clinical studies Profilactic or therapeutic vaccine efficacy

17 NBR ISO IEC 17025 Quality Control

18 Immune potentiators or immune regulators
NBR ISO IEC 17025 Modern vaccines Antigens Immune potentiators or immune regulators (Adjuvants) Academy Regulation Delivery systems Quality Control Scalle up Company Pre-clinical and clinical studies Profilactic or therapeutic vaccine efficacy

19 Guidelines for Nonclinical Safety Assessment
NBR ISO IEC 17025 Guidelines for Nonclinical Safety Assessment

20 Nonclinical Toxicity Studies
NBR ISO IEC 17025 Nonclinical Toxicity Studies

21 Types of Nonclinical Toxicity Studies
NBR ISO IEC 17025 Types of Nonclinical Toxicity Studies

22 Immune potentiators or immune regulators
Modern vaccines Antigens Immune potentiators or immune regulators (Adjuvants) Academy Regulation Delivery systems Quality Control Scalle up Company Pre-clinical and clinical studies Profilactic or therapeutic vaccine efficacy

23 Certification Boas Práticas de Laboratório BPL
NBR ISO IEC 17025 Certification Boas Práticas de Laboratório Organização dos processos e das condições sob as quais os ensaios serão: Planejados; Executados; Monitorados; Registrados, Relatados BPL Exigências Regulatórias Nacionais e Internacionais: ANVISA INMETRO FDA (USA) CE (EUROPA) NRB ISO/IEC 17025:2005

24 Boas Práticas de Laboratório
NBR ISO IEC 17025 CERTIFICAÇÕES Certificações Eficácia e Segurança Facilidades para registro de Produtos Diferencial competitivo Adequação ao mercado internacional Boas Práticas de Laboratório

25 Agradecimentos