Presentation on theme: "HIV Vaccine Research at CRT-DST/AIDS Artur Olhovetchi Kalichman."— Presentation transcript:
HIV Vaccine Research at CRT-DST/AIDS Artur Olhovetchi Kalichman
CRT DST/AIDS The STD/Aids Reference and Training Center belongs to the São Paulo State Health Department and it is responsible for the Coordination of the STD/Aids Program in the State. The CRT-DST/AIDS is also responsible for inpatient and outpatient care for HIV infection and other STDs. The CRT-DST/AIDS also performs clinical research to develop new ARV drugs for the treatment of PLHA and HIV preventive vaccines. The HIV Vaccine Research Unit of the CRT-DST/AIDS starts its activities in 2001 as a member of the HIV Vaccine Trial Network (HVTN).
DAIDS Sponsored Networks (parcial / 12 of 23) AIEDRP Programa de Pesquisas sobre Infecção Aguda e Doença Precoce PACTG Grupo de Ensaios Clínicos sobre AIDS Pediátrico HPTN Rede de Ensaios Clínicos de Prevenção contra o HIV NCDDG Grupos Nacionais de Descoberta Cooperativa de Drogas AACTG Grupo de Ensaios Clínicos sobre AIDS em Adultos CFAR Centros para Pesquisa sobre AIDS CPCRA Programa Comunitário de Pesquisas Clínicas sobre AIDS CIPRA Programa Internacional Extenso de Pesquisas sobre AIDS HVTN HIV Vaccine Trial Network MACS Estudo Multicêntrico de Coortes com AIDS WITS Estudo de Transmissão em Mulheres e Lactentes ESPRIT Avaliação da Proleuquina Subcutânea em um Ensaio Clínico Aleatorizado Internacional
Laboratories *Duke University *California Department of Public Health Sciences *Fred Hutchinson Cancer Research Center *Nat’l Institute for Communicable Diseases Laboratories *Duke University *California Department of Public Health Sciences *Fred Hutchinson Cancer Research Center *Nat’l Institute for Communicable Diseases Core Operations Center Fred Hutchinson Cancer Research Center Core Operations Center Fred Hutchinson Cancer Research Center Statistical and Data Management Center (SCHARP) Fred Hutchinson Cancer Research Center Statistical and Data Management Center (SCHARP) Fred Hutchinson Cancer Research Center HVTUs
HVTN Clinical Trial Sites *Kingston, Jamaica *San Juan, Puerto Rico *Soweto, South Africa *Gaborone, Botswana * Santo Domingo, Dominican Republic *Blantyre, Malawi Pune, India Chiang Mai, Thailand Nanning, China Seattle, WA San Francisco, CA *Iquitos, PeruLima, Peru Port-au-Prince, Haiti *Sao Paulo, Brazil Rio de Janeiro, Brazil Port of Spain, Trinidad & Tobago * Durban, South Africa St. Louis, MO Rochester, NYNew York, NY Baltimore, MD Boston, MA Providence, RI Washington, DC Birmingham, AL Nashville, TN Updated on 12/14/04 Sites for current HVTN trials * Joined the HVTN since 1999 Sites for future HVTN trials Kunming, China * Cape Town, South Africa *Philadelphia, PA *Chicago, IL *Orkney, South Africa
Protocol and Consent form assessments Community Education Advise on Recruitment & Retention Representative voice for participants - Community Liason - Recruitment -Retention CORE Community Education Community Advisory Board Research Team
Unit Coordination : Clinic Coordination, Data Management and Quality Control, Legal and Regulatory issues from Brasil and USA, SOP development, Staff Training, Pharmacist (responsible for receiving, storage, control and preparation of the investigational products). Field Team: Physicians, nurses, counselors, receptionist and Phlebotomists. Research Team
CEP/CONEP: The CRT-DST/Aids has its own IRB since 1998. Our IRB is responsible for the assessment of our protocols and for send it to CONEP for their assessment CIBio/CTNBio: The local Biohazard Committee of the Instituto Adolfo Lutz is responsible for the assessment of our protocols and for send it to CTNBio for their assessment ANVISA: To prepare the paperwork to obtain the permit for importing the product and perform the trial in the country according with the vaccine developer HVTN/DAIDS/FDA: To comply with all legal and regulatory research legislation from the USA Legal and Regulatory Aspects
Feasibility Study January 2003 to March 2005 Heterosexual coorte Participants- 211 men and women Protocol 050 Follow up Period (Year 3) Vector: Adenovirus type 5 Phase 1: Safety and Immunological response Participants: 18 to 50 years HIV negative and healthy Enrolled: 19 participants Begin: 2004 Vaccine Trials CRT DST/AIDS
Protocol 055 Follow up Period (month 7) Phase I: Safety and Immunological response Vector: MVA and FPV Participants: 18 to 24 years HIV negative and healthy Enrolled: 21 participants Begin: 2006 Protocolo 204 Recruitment: begin in August 2006 Phase II A – Safety and Immunological response Product: multiclade HIV-1 DNA plasmid vaccine followed by a multiclade recombinant adenoviral vector HIV-1 vacccine boost Participants: 18 to 45 years, HIV negative and healthy Enrolled: 4 (untill 30 sep 2006) Target: 12 participants Vaccine Trials CRT DST/AIDS
Protocolo 502 Recruitment: begin in August 2006 Phase II B – Safety, Immunological response and efficacy Vector: Adenovirus type 5 Participants: 18 to 45 years Enrolled: 1 participant Target: 65 45 men 20 women Protocolo 063 Approved for CEP, CONEP ANVISA and CTNBio: under assessment Recruitment: November 2006 Phase I – Safety and Immunological response Product: HIV-1 gag DNA vaccine alone or with IL-15 DNA, boosted with HIV-1 gag DNA + IL ‑ 15 DNA, HIV CTL multiepitope peptide vaccine, or HIV-1 gag DNA + IL-12 DNA Participants: 18 to 50 years Participants: 12
Policy: To establish a governmental policy for the participation of Brazil in international vaccine research networks and multilateral initiative. This policy should provide the conditions to support technological development in the field and future access to the vaccine. Regulatory and legal: To reconcile different research legislations To guarantee that the Brazilian legislations on research are obeyed To guarantee that the time for approval process in the country do not compromise the beginning of the protocols at the same pace that the other participants countries. CHALLENGES CHALLENGES
E-mail email@example.com Home page www.crt.saude.sp.gov.br/vacinas
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