hiv vaccine research at crt-dst/aids artur olhovetchi kalichman
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HIV Vaccine Research at HIV Vaccine Research at
CRT-DST/AIDSCRT-DST/AIDS
Artur Olhovetchi KalichmanArtur Olhovetchi Kalichman
CRT DST/AIDSCRT 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)DAIDS Sponsored Networks (parcial / 12 of 23)
AIEDRPPrograma de Pesquisas sobre
Infecção Aguda e Doença
Precoce
PACTGGrupo de Ensaios Clínicos sobre
AIDS Pediátrico
HPTNRede de Ensaios Clínicos de
Prevenção contra o HIV
NCDDGGrupos Nacionais de
Descoberta Cooperativa de Drogas
AACTGGrupo de Ensaios Clínicos
sobre AIDS em Adultos
CFARCentros para Pesquisa sobre AIDS
CPCRAPrograma Comunitário de
Pesquisas Clínicas sobre AIDS
CIPRAPrograma Internacional Extenso
de Pesquisas sobre AIDS
HVTNHIV Vaccine Trial Network
MACSEstudo Multicêntrico de
Coortes com AIDS
WITSEstudo de Transmissão em
Mulheres e Lactentes
ESPRITAvaliação 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 CenterFred Hutchinson Cancer
Research Center
Core Operations CenterFred 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, Peru Lima, Peru
Port-au-Prince, Haiti
*Sao Paulo, Brazil
Rio de Janeiro, Brazil
Port of Spain,Trinidad & Tobago
* Durban, South Africa
St. Louis, MO
Rochester, NY New 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 assessmentsCommunity EducationAdvise 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 TeamResearch 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 assessmentCIBio/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 assessmentANVISA: 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 AspectsLegal and Regulatory Aspects
Feasibility StudyJanuary 2003 to March 2005Heterosexual coorteParticipants- 211 men and women
Protocol 050 Follow up Period (Year 3)Vector: Adenovirus type 5Phase 1: Safety and Immunological responseParticipants: 18 to 50 yearsHIV negative and healthy Enrolled: 19 participantsBegin: 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/AIDSVaccine Trials CRT DST/AIDS
Vaccine Trials CRT DST/AIDSVaccine Trials CRT DST/AIDSProtocolo 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.
CHALLENGESCHALLENGES
Home page
www.crt.saude.sp.gov.br/vacinas