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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

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HIV Vaccine Research at CRT-DST/AIDS Artur Olhovetchi Kalichman

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Hiv vaccine research at crt dst aids artur olhovetchi kalichman

HIV Vaccine Research at

CRT-DST/AIDS

Artur Olhovetchi Kalichman


Crt dst aids

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

DAIDS Sponsored Networks (parcial / 12 of 23)

AIEDRP

Programa de Pesquisas sobre

Infecção Aguda e Doença

Precoce

AACTG

Grupo de Ensaios Clínicos

sobre AIDS em Adultos

CFAR

Centros para Pesquisa sobre AIDS

PACTG

Grupo de Ensaios Clínicos sobre

AIDS Pediátrico

CPCRA

Programa Comunitário de

Pesquisas Clínicas sobre AIDS

CIPRA

Programa Internacional Extenso

de Pesquisas sobre AIDS

HPTN

Rede de Ensaios Clínicos de

Prevenção contra o HIV

HVTN

HIV Vaccine Trial Network

MACS

Estudo Multicêntrico de

Coortes com AIDS

ESPRIT

Avaliação da Proleuquina Subcutânea

em um Ensaio Clínico

Aleatorizado Internacional

WITS

Estudo de Transmissão em

Mulheres e Lactentes

NCDDG

Grupos Nacionais de

Descoberta Cooperativa de Drogas


Hiv vaccine research at crt dst aids artur olhovetchi kalichman

HVTUs

Statistical and Data

Management Center

(SCHARP)

Fred Hutchinson Cancer

Research Center

Core Operations Center

Fred Hutchinson Cancer

Research Center

Laboratories

*Duke University

*California Department of Public

Health Sciences

*Fred Hutchinson Cancer Research Center

*Nat’l Institute for

Communicable Diseases


Hvtn clinical trial sites

HVTN Clinical Trial Sites

Rochester, NY

New York, NY

Providence, RI

*Chicago, IL

Sites for current HVTN trials

*Philadelphia, PA

St. Louis, MO

Sites for future HVTN trials

Seattle, WA

* Joined the HVTN since 1999

Boston, MA

San Francisco, CA

Baltimore, MD

Pune, India

Washington, DC

Nashville, TN

Birmingham, AL

Nanning, China

Port-au-Prince, Haiti

*San Juan, Puerto Rico

Chiang Mai, Thailand

*Kingston, Jamaica

Kunming, China

* Santo Domingo, Dominican Republic

*Blantyre, Malawi

*Orkney, South Africa

*Gaborone, Botswana

Port of Spain,

Trinidad & Tobago

Rio de Janeiro, Brazil

*Soweto, South Africa

*Sao Paulo, Brazil

*Iquitos, Peru

Lima, Peru

* Durban, South Africa

* Cape Town, South Africa

Updated on 12/14/04


Hiv vaccine research at crt dst aids artur olhovetchi kalichman

CORE

Community Education

Research Team

  • - Community Liason

  • - Recruitment

  • Retention

Community Advisory Board

Protocol and Consent form assessments

Community Education

Advise on Recruitment & Retention

Representative voice for participants


Hiv vaccine research at crt dst aids artur olhovetchi kalichman

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.


Hiv vaccine research at crt dst aids artur olhovetchi kalichman

Legal and Regulatory Aspects

  • 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


Hiv vaccine research at crt dst aids artur olhovetchi kalichman

Vaccine Trials CRT DST/AIDS

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


Hiv vaccine research at crt dst aids artur olhovetchi kalichman

Vaccine Trials CRT DST/AIDS

Protocol 055Follow 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 204Recruitment: 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


Hiv vaccine research at crt dst aids artur olhovetchi kalichman

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


Hiv vaccine research at crt dst aids artur olhovetchi kalichman

CHALLENGES

  • 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.


Hiv vaccine research at crt dst aids artur olhovetchi kalichman

E-mail

[email protected]

Home page

www.crt.saude.sp.gov.br/vacinas


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