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Ethical Issues in HIV Vaccine Trials : An Ethical Case Study and Community Responses' Is this a conc

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Title: Ethical Issues in HIV Vaccine Trials : An Ethical Case Study and Community Responses' Is this a conc


1
Ethical Issues in HIV Vaccine Trials An Ethical
Case Study and Community Responses.Is this a
concern for China?
  • Ronald P. Strauss
  • University of North Carolina at Chapel Hill

2
  • Human Clinical Trials
  • Phase One - Safety
  • Phase Two Demonstrate that a vaccine produces
    measurable biological change, not protection from
    the disease
  • Phase Three
    Clinical
    population-level
    effectiveness

3
HVTN- HIV Vaccine Trials Network
established in May 2000 AIDSVAX Phase III
Clinical Trial US sites plus Puerto Rico,
Netherlands, Thailand Results expected Spring
2003. Sponsored by NIH and VaxGen Efficacy
Issues? Availability Issues?
4
The First
Phase II/III
HIV
Vaccine Trial HVTN trial of prime-boost
combination of a canary pox-HIV
construct which stimulates cellular immune
responses together with a gp120 candidate
  Enrollment 5400 persons at risk for exposure
5
  • LinCS Studied 4 Target Communities To anticipate
    vaccine trials.
  • Philadelphia Injecting Drug Users
  • San Francisco Young Gay Men
  • Durham
    African Americans
  • HIV Vaccine
    Scientists

6
  • 4 Types of LinCS Interviews
  • Community-Environment
  • Information-Influence
  • Vaccine Clinical Trials
  • Scientist substudy

7
  •  Community-Environment
  • Definitions of
    community
  • Segments of
    communities
  • Leadership
  • Attitudes about biomedical research
  • Community strengths and issues
  • Place of AIDS relative to other community issues

8
Information-Influence How individuals learn
about HIV/AIDS  How information
flows  Trustworthy
information sources  Elements of building
trust  Social contexts for decision-making about
research
9
Vaccine Clinical Trials  Benefits and risks of
trial participation  HIV/AIDS as a community
concern  Informational needs  Guidance in how
to conduct science
that is sensitive to
communities  Perceptions of vaccines
10
Scientist Substudy  Linkages with Scientific
Community  Linkages with Study
Communities  Sources of information about
communities  Ethical behaviors relative to study
participants  Perceived risks and benefits of
trial participation
11
  • In depth interviews
  • 269 Site participants
  • 45 Scientist participants
  • Over 12,000 qualitative themes identified
  • Over 10,000 pages of transcription

12
Project faced questions about dissemination of
policy and ethically important findings  How do
you present information so that scientists and
the public will listen?  What do scientists
read?  How do you best disseminate
information and findings to
participants?
13
Strategies for Dissemination Video WE ALL
HAVE OUR REASONS  Brochure TAKING PART IN
RESEARCH STUDIES WHAT QUESTIONS SHOULD YOU
ASK?  Scholarly Papers  Newspapers LESSONS
LEARNED
14
What are the ethical and social dilemmas we found
embedded in HIV preventive vaccine trials?
15
 1. Conflict of interest for investigators
between educating people not to expose themselves
to HIV, but knowing that if they succeed
they wont
be able to test the vaccine 2. Sexual and other
risk factor
education 3. Acting more risky in spite of
warnings because of being in a
study 4. Therapeutic misconception
16
5. Misunderstanding placebos in clinical
trials 6. Informed consent, literacy,
understanding, cultural sensitivity 7.
Marginalized and disenfranchised communities 8.
Distrust of federal government and public health
researchers 9. Control of the research/CABs
17
10. Fear of getting AIDS from the vaccine 11. HIV
seroconversion during trial 12. Accessing HIV
testing PCR tests Privacy
18
13. Donating blood, travel,
military, government jobs
program 14. Mandatory HIV tests for
insurance or employment 15.
Participation in future
trials 16. Prejudice, stigma associated
with HIV/AIDS risk
19
17. Less than optimal vaccine efficacy public
health vs. individual perspective 18. Time it
takes to get sick if later become HIV
infected 19. Discomfort or
side-effects 20. Subject
payment
and incentives
20
 21. Similarity and difference between
Doctor/Patient relationships and
Investigator/Subject 22. Treatment for people who
seroconvert during or after
Trials 23. Use of research
products access after
Trials what is left for community? 24. Promises
of full-disclosure to participants
21
25. Conflict of Interest/funding corporate vs.
government vs. universities 26. International
vaccine testing clades/strains/study
sites 27. International study sites
What standard of care? 28. RCT
early efficacy, DSM data safety manager, Trial
completion
22
Spring 2003
  • Awaiting results from AIDSVAX
  • Dealing with disappointment or success
  • Preparing for future trials
  • What makes a clinical trial successful? Is it
    enough to have completed the trial?

23
Video We All Have Our ReasonsDiscussion and
Questions
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