AN HIV Vaccine Trial in the Caribbean: The Haiti Site Experience

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AN HIV Vaccine Trial in the Caribbean The Haiti
Site Experience

• S. Jean, J. Pape, M. Deschamps, A. Maxi, R.
  Verdier, T. Yamamoto, D. Fitzgerald, W. Johnson,
  P.Wright
• Centres GHESKIO, Port-au-Prince, Haiti
• Weill Medical College of Cornell University, New
  York, N.Y, USA
• Sponsored by NIH

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INTRODUCTION

• HIV Vaccine trials are a very sensitive topic
  worldwide, with a high level of Government
  scrutiny and press coverage. As a part of its
  contribution in the global effort to control the
  AIDS pandemic, GHESKIO Centers were the first
  Caribbean site to initiate HIV vaccine trial in
  March 2001. I am very happy to share with you
  this successful experience.

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Plan of the Presentation

• The Institution, GHESKIO Centers
• Mission
• Patient care providing
• Training of Health Professionals
• Implementation of Research
• Site Preparation for HIV Vaccine Trials
• Political commitment by the government
• Community support
• Capacity building

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Plan of the Presentation (cond t)

• The HVTN 026 Protocol
• Objectives
• Summary of the protocol
• Results
• The development of appropriate strategy to
  improve Informed Consent
• Conclusion

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The Institution GHESKIO Centers

• Non governmental organization (NGO) (1982)
• Mission  services, research, and training
• Collaboration
• Local Institutions 
• Haitian Ministry of Health and Population,
  Haitian Medical Association and 114 other
  institutions
• International Institutions
• American Universities  Cornell (1982),
  Vanderbilt (1989), Johns Hopkins, Harvard (1991),
  Hastings Center (1999)
• French Institutions Institut Alfred Fournier
  (1989), Institut Pasteur (1999), Université
  dAmiens (1999)

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Voluntary Counseling and testing Centers (VCT)
with integrated services

• As VCT GHESKIO Centers offer
• The opportunity to intervene in both prevention
  and care
• The possibility to recruit volunteers for HIV
  Vaccine trials

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GHESKIO Centers Profile

• GHESKIO Centers are the main VCT center in Haiti.
  In 2003, over 21,279 individuals were tested for
  HIV. 50 are aged 18-50 years, of which 70
  are HIV negative, and candidates for vaccine
  trials.
• A mean of 500 persons a day come for health care
• Training as of November 2003, 6799 health care
  providers were trained

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Implementation of Research

• Since its inception in 1982, GHESKIO has emerged
  as a national and international leader in the
  fight against AIDS. Through its mission to
  provide patient care and train health
  professionals, GHESKIO developed a mutual trust
  with the community, which permitted
  implementation of research. As a part of its
  contribution in the global effort to control the
  pandemic, GHESKIO Centers was the first Caribbean
  site to initiate HIV vaccine trial in March 2001.

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PREPARATORY PHASE FOR HIV VACCINE TRIAL
(1991-2001)

• Political Commitment by the government
• Community Support
• Ethics Support
• Competency of the staff
• Capacity building
• Evaluation of potential study population
• Supported by NIH PAVE, HIVNET, HVTN, AITRP

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HVTN 026

• Haiti participated with Trinidad, Brazil, Peru in
  a Multisite Phase II Clinical Vaccine Trial to
  evaluate two candidate vaccines the ALVAC 1452
  HIV -1 (Aventis Pasteur) and rgp120 (Vaxgen)

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OBJECTIVES

• To confirm the safety and to define the
  immunogenicity of both products in populations
  represented by different genetic pools and other
  host factors, such as nutritional status, that
  may impact on responses to the vaccines
• To establish the capability of testing HIV
  vaccines in international sites to prepare for
  larger scale trials

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Summary of the protocol

• 40 healthy volunteers (18 to 60 years old) in
  each site, were randomly assigned in 3 groups to
  receive
• 1- Both products (ALVAC, rgp120) n 15
• 2 -One product ( ALVAC alone) n 15
• 3 - Placebos n 10
• They were assigned to receive 4 doses in 6 months
  at 0, 1, 3, 6 months

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Summary of the protocol (contd)

• Duration of the follow - up 18 mo post
  enrollment
• End points were
• Safety measurements
• Immunogenicity measurements
• Detection of intercurrent infection

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Strategy to improve informed Consent

• Sensitization
• Willingness Questionnaire
• Educational sessions
• Evaluation of the comprehension before signing
  the Consent Form
• Evaluation of the level of motivation before
  enrollment

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Sensitization
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Willingness to Participate

• During post-test counseling, sensitization is
  done on an individual basis by a social worker.
  Interested healthy HIV negative adults 18 60
  years old are referred to the HIV vaccine Unit
  for a Willingness Questionnaire

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Willingness Questionnaire

• Knowledge about vaccines in general is tested
• Information about HIV vaccine trials worldwide is
  given
• Questions are asked, for example
• Would you be willing to participate knowing
  that your HIV test may become positive?
• In 2001, of 2,060 interviewed, 78 were
  interested in participating.

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Obtaining Informed Consent

• The procedure used in informed consent had been
  designed to educate the subject population in
  terms that they could understand all aspects of
  the protocol before signing the consent form.
• The consent form has been translated into Creole
• An illustrated booklet has been written, in which
  standardized questions dealing with key issues of
  the protocol have been debated.

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Educational Booklet
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Obtaining Informed Consent

• At least, three (3) educational sessions of one
  (1) hour each were provided to each volunteer
• The comprehension and the level of motivation
  was evaluated by a psychologist not involved in
  the educational sessions.
• From 680 volunteers that took part in the
  pre-screening process (026 protocol), 244 were
  eligible following clinical laboratory
  screening
• 81/244 signed the informed consent form

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Enrollment

• Before enrollment, a second evaluation was
  performed by the P.I., Co-P.I. and the ethics
  liaison person to assure that volunteers had
  really understood the study and were motivated to
  participate.
• From the 81 subjects who signed the consent form,
  50 passed all stages including the second
  evaluation
• 40 were enrolled in the 026 protocol with 100
  retention

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RESULTS

• The products were proven to be safe, well
  tolerated
• Follow up 100 of retention
• No HIV infection
• At the end of the study 85 (12/14) of those who
  received both products had antibodies induced by
  the vaccines (positive ELISA by Abbott)

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RESULTS (contd)

• 73 (11/15) of those who received the ALVAC alone
  had antibodies induced (positive ELISA by Abbott)
• Further immunogenicity data are not available yet
  

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Conclusion

• With sufficient time and care it is possible to
  obtain proper informed consent from a population
  with limited formal education. We were able to
  obtain 100 of retention after completion of the
  study. In the group inoculated with candidate
  vaccines, HIV antibodies were detected with
  conventional HIV screening tests in a majority of
  the participants.

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Conclusion (contd)

• This information is important to give to
  participants in an HIV vaccine trial to alert
  them to the potential for stigmatization and
  social harms.
• The clinical and laboratory capacity built for
  HIV Vaccine Trials has strengthened patient care
  and other research and training activities at
  GHESKIO.

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Conclusion (contd)
Based on this successful experience, Haiti is
selected to conduct other HIV vaccine trials. Our
site is now activated for the evaluation of the
new Merck vaccine and will be ready for a Phase
III trial.