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Brazilian Ministry of Health Oswaldo Cruz Foundation Oswaldo Cruz Institute Mariza G. Morgado Lab. AIDS & Molecular Immunology HIV Vaccine Research: Ethical.

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Presentation on theme: "Brazilian Ministry of Health Oswaldo Cruz Foundation Oswaldo Cruz Institute Mariza G. Morgado Lab. AIDS & Molecular Immunology HIV Vaccine Research: Ethical."— Presentation transcript:

1 Brazilian Ministry of Health Oswaldo Cruz Foundation Oswaldo Cruz Institute Mariza G. Morgado Lab. AIDS & Molecular Immunology HIV Vaccine Research: Ethical and Regulatory Issues PN-DST/AIDS – Brazilian Ministry of Health Brasília – Out 2006 Brazilian Experiences in Collaborative and Preventive Multicentric Studies – FIOCRUZ

2 Objective: To obtain information on genetic and antigenic variation of HIV and its possible implications for vaccine development Primary laboratories – Brazil, Rwanda, Thailand and Uganda Secondary International laboratories for: Standardized virus isolation – repository Genetic subtyping – PCR gag fingerprint, HMA, V3 loop and env DNA sequencing Biological and immunological characterization - peptide binding EIA, CD4/gp120 blocking antibodies, in vitro replication characteristics and cross-neutralization assays WHO-Global Programme on AIDS Network for HIV Isolation and characterization

3 Brazilian Network of HIV Isolation and Characterization Objective: To establish a Brazilian surveillance program to monitor the genetic and antigenic variation of HIV and its possible implications for vaccine development Identification of potential participants; Organization of local seminars for protocol definition and implementation; Submission to WHO and PN-DST/AIDS funding; Organization of local “International Workshop Trainings”; In-country and international personnel trainings; Elaboration and conduction of scientific projects Major strategies (1993)

4 For. Braz. No. of papers Source: PubMed – Key words: HIV and Brazil * Papers including HMA, DNA sequencing, RFLP, Neutralizing antibodies, peptide ELISA, ELISPOT, CMI (N=106) (N=120)(N=242)(N=189) (N=194) (N=285) (N=113) Medline available scientific publications

5 B, F, B/F B, F, B/F, C, D, A,CRF02_AG, CRF28_BF, CRF_29BF C, B, B/C, F, B/F, A B, F, B/F B, F, B/F, C Molecular epidemiology of HIV-1 in Brazil Updated 2006

6 Rio de Janeiro, RJ Belo Horizonte, MG São Paulo,SP Porto Alegre, RS NICHD/HPTN 040 PHASE III RAMDOMIZED TRIAL OF THE SAFETY AND EFFICACY OF THREE NEONATAL ANTIRETROVIRAL REGIMENS FOR PREVENTION OF INTRAPARTUM HIV-1 TRANSMISSION HPTN 052 A RANDOMIZED TRIAL TO EVALUATE THE EFFECTIVENESS OF HIV PRIMARY CARE VERSUS HIV PRIMARY CARE PLUS ANTIRETROVIRAL THERAPY TO PREVENT THE SEXUAL TRANSMISSION OF HIV-1 IN SERODISCORDANT COUPLES Clinical Research - Brazilian HPTN Protocols NICHD/HPTN 040 NICHD/HPTN 040/HPTN052

7 BB FF CC BC BF CBF Morgado et al.2004 CROI * * RJ (n=39) 3% 10% 87% PoA (n=64) 61% 25% 11% 3% HIV-1 subtype infection among pregnant women from Rio de Janeiro, RJ, and Porto Alegre, RS RJ N=3, % of seropositive women (49) PoA N=1,524 6,3% of eropositive women (99) (env & pol)

8 Good Laboratory Practices Biosafety rules Ethical Issues Regulatory Issues Major requirements for project participation

9 Central Laboratory ldo Cruz Foundation) HSE and HGNI Rio de Janeiro, RJ Plasma, blood cell pellets and cryopreseved mononuclear cells UFSP São Paulo, SP UFMG Belo Horizonte, MG HC, HF, HSC Porto Alegre, RS FIOCRUZ, RJ Study Coordination Data Manegement Central Laboratory NICHD-HPTN040 – Strategy shipping, storage and testing of biological samples Repository RNA and DNA assays Plasma, blood cell pellets and cryopreseved mononuclear cells Plasma, blood cell pellets and cryopreseved mononuclear cells Plasma, blood cell pellets and cryopreseved mononuclear cells Transport of clinical specimens Results Transport of clinical specimens

10 ldo Cruz Foundation) Hosp. Geral de Nova Iguacu Sample processing Sample storage LDMS CD4 counts Hospital dos Servidores * Reference of Genotyping also for the following centers: Hospital Conceição, RS IMPACTA, Lima, Peru FIOCRUZ, RJ Sample processing Sample storage/LDMS RNA assay CD4 counts Genotyping * Hematol./Biochem/Immunol/Microbiol Shipping & Training Sample processing Sample storage LDMS Clinical specimens Results Johns Hopkins Central Lab HPTN052 – Strategy shipping, storage and testing of biological samples

11 Laboratory procedures INMETRO NIT-DICLA 083 / ISO-IEC SOPs Internal and external controls Data register Data storage and control Results

12 Sample processing and storage in biosafety conditions Biological repository maintenance Cryopreserved mononuclear cells Plasma Sera Blood cell pellets * RESOLUÇÃO N o 347, DE 13 DE JANEIRO DE 2005

13 National and international laboratory certifications UKNEQAS (England)– Immunophenotyping Virology Quality Assessment Program (USA) – DNA PCR; RT-PCR; Genotyping Immunology Quality Assessment Program – PBMC cryopreservation College of American Pathologists (USA) – CBC, serology, etc Brazilian AIDS Program – immunophenotyping, VL and Genotyping

14 Major ethical and regulatory issues Timeline to get the protocols approved. Concerns about the storage of biological samples for further studies. Timeline to prepare the documents (IL) and have them accepted for drug and reagent reception Timeline to prepare the documents and have them accepted for importation and/or customs clearance of biological panels for laboratory proficiency tests. Constant modifications in documentation required for shipping and/or clearance of drugs, reagents, and biological materials, including proficiency panels.


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