bioethics: Case Discussion-HIV Vaccine Trials and Antiretroviral

[bioethics@hsphsun2.harvard.edu]

> >Case 2. HIV Vaccine Trials and Antiretroviral Therapy
> >
> >A country in East Africa has a high HIV/AIDS incidence (clade C) coupled
> >with a good infrastructure. Because of the increasing number of women with
> >AIDS, mother to child transmission has become an issue. For these reasons,
> >HIV/AIDS vaccine developers have considered this country to be a prime
> >location for vaccine trials.
> >
> >The country has a strong Drug Regulatory Authority (DRA), and received
> >submissions in 2002 for two separate Phase I vaccine trials. The first
> >trial was for a clade C VEE vaccine developed by a European biotech company
> >and already approved for safety studies in Europe. This was to have been
> >the first trial of a clade C vaccine in an area of high clade C prevalence.
> >The second trial was for a Modified Vaccinia Ankara clade A vaccine
> >designed by a Japanese-Thai collaboration and already tested in both
> >countries and shown to be safe and immunogenic. This trial would be
> >important in looking at cross-protective responses in a clade C setting.
> >
> >Since the demonstration of the efficacy of HAART (highly active
> >anti-retroviral therapy) for treatment of HIV/AIDS, it has become the
> >standard of care in industrialized countries. In resource-poor countries,
> >the expense of HAART generally puts it out of reach for most citizens. The
> >East African countries government was reluctant to adopt antiretroviral
> >therapy. International practice recommends a universal standard of care for
> >clinical trial subjects, suggesting that they should be offered HAART
> >should they develop HIV/AIDS during the course of a trial. UNAIDS
> >guidelines recommends agreement on a comprehensive care package prior to
> >the trial, with the minimum standards the best intervention available as
> >part of the national public health system. In the east African country,
> >this would have meant no preventive treatment for HIV/AIDS; however, AIDS
> >activists were pressuring the government to put AIDS treatment protocols
> >into general use.
> >
> >Before any decision could be made on the authorization of these two trials,
> >the Ethics Committee of the DRA put a hold on approval of all HIV/AIDS
> >vaccine trials, pending a consensus on what to do about long term treatment
> >of people who become infected during trials.
> >
> >The trials were finally authorized in the summer of 2003, after the East
> >African countries government was enjoined by court order to make
> >antiretroviral therapy available to all pregnant women.
> >
> >Question:
> >     * Can the decision to place all HIV/AIDS trials on hold by the DRA be
> >defended, given that the safety had been already demonstrated and
> >immunogenicity in the East African country setting was an issue of
> >international importance?
> >     * Was the hold related to risk-benefit decisions made in industrialized
> >countries? If so, were these decisions relevant for the situation in the
> >East African country.
> >
> >
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