to officially open the South African AIDS Vaccine Initiative (SAAVI) Scientific
Advisory Committee meeting, Wanderers Club, Illovo, Johannesburg
19 July 2006
Members of the Scientific Advisory Committee,
MRC board members,
Representatives of the funders,
Professor Anthony Mbewu, MRC President,
SAAVI Principal Investigators,
Ladies and gentlemen:
It is my honour to be with you today and to address you on the outstanding
progress made by the South African AIDS Vaccine Initiative.
The South African AIDS Vaccine Initiative (SAAVI), a lead programme of the
Medical Research Council of (MRC) was created in 1999 by the government and
Eskom.
SAAVI receives its core funding from Eskom and from the Departments of
Health and of Science and Technology, Transnet, Impala Platinum and the
European Union (EU) as additional funders.
Its role is to develop an affordable, effective and locally relevant
HIV/AIDS vaccine in as short a time as possible.
The initiative therefore co-ordinates the activities of investigators at the
South African academic institutions.
Activities range from laboratory development of vaccines and immunology to
clinical trials, ethics and behavioural research, community education and
mobilisation, actuarial science and bioinformatics.
An emphasis to date has been on creating novel biotechnology platforms to
develop test HIV vaccines and on the development of a clinical and social
environment conducive to running HIV vaccine trials.
It is, therefore, on the social environment and the values underlying
SAAVI's research portfolio that I would like to spend a little time today.
As you know, HIV infection and the impact of AIDS are having a devastating
effect on South and southern Africa.
Up to now prevention efforts have still been too limited and treatments for
HIV/AIDS although effective in prolonging life are not curative.
A vaccine may be the only way to bring the epidemic to a stop.
However, the historical background of AIDS vaccine development is rooted in
a legacy of exploitation in science, colonialism and apartheid as well as
suspicion of research in communities particularly in poor and disadvantaged
communities.
Hence some of the South African communities that will be involved in AIDS
vaccine trials may be experiencing a legacy of poor health and underdevelopment
as well as high degrees of disparity and inequities in respect of gender,
health and socio-economic status.
Notwithstanding these challenges, AIDS vaccine development play s a key role
in South African research and clinical trial infrastructure and capacity
development and has spurred the development of wide ranging ethical, socio
behavioural research and community involvement initiatives.
It is my understanding that a range of both abstract and concrete inhibitors
to trial participation in South Africa have already been identified in research
commissioned by SAAVI.
AIDS vaccine development is a global pursuit, requiring intense and
sustained international collaboration.
Community involvement is an integral part of such collaboration and
co-ordination.
Any public health intervention must be participatory and have a community
involvement component.
It was therefore necessary to develop and test AIDS vaccines in South Africa
with a dedicated community involvement component from the outset.
SAAVI has therefore since 2000 supported community involvement which has
developed under the South African HIV vaccine action campaign, through the
SAAVI Community Preparedness Programme and now with the SAAVI Community
Involvement Programme, Masikhulisane.
I am also told that Masikhulisane is a public sector community involvement
programme of the MRC supporting not only the development of South African
products or products developed by SAAVI but also the testing in South Africa of
products developed elsewhere or through international collaboration.
It is also my understanding that all SAAVI research is guided by the values
of dignity, equality, transparency, inclusiveness and empowerment and the human
rights elaborated in the Trial Participant Charter of Rights as well as ethics
elaborated in the medical research council guidelines for ethics in medical
research and other South African ethical and good clinical practice
guidelines.
Masikhulisane has developed the AIDS Vaccine Trial Participant Charter of
Rights as a representation of these values in a framework of constitutional
human rights.
It is important to note that the Charter focuses largely on one aspect of
participation namely participation as a clinical trial participant, although
its values and human rights aim to have an impact far beyond trial participants
themselves and encapsulates the approach of the Masikhulisane community
involvement model.
The human rights that are elaborated in the Trial Participant Charter
are:
* the right not to be subjected to medical or scientific experimentation
without their informed consent
* the rights of equality and non-discrimination
* the right to human dignity
* the right of access to health care services
* the right to privacy
* the Trial Participant Charter also elaborates on responsibilities of trial
participants
* the ethical integrity and scientific validity of AIDS vaccine development
must be maintained as required by ethical and good clinical practice
guidelines
* the MRC guidelines for ethics in medical research Book V on HIV preventive
vaccine research, as well as the Department of Health guidelines on ethics and
good clinical practice must also be implemented
* AIDS vaccine development also remains a key element of South Africaâs
comprehensive AIDS strategy.
It is important, however, that vaccine development is not viewed as a stand
alone strategy but integrates a comprehensive response to the AIDS
epidemic.
AIDS vaccine development should be understood and approached within the
context of a broader South African programme of prevention and a national
community prevention alliance.
Therapeutic vaccines are also being pursued and supported and these may fit
in more easily with the treatment agenda.
There is now a greater acknowledgement of both the therapeutic and
preventive potential of vaccines and SAAVI is now actively pursuing an
encompassing strategy.
I believe also that SAAVI should take cognisance of the scientific and
clinical development of other novel methods and products as well as clinical
testing of traditional medicines.
AIDS vaccines need to be contextualised within prevention, treatment, care
and support.
Progress in clinical trials, on the scientific and clinical side I believe
that SAAVI has been a model of outstanding progress.
The first two phase-one clinical trials commenced at two sites in November
2003.
Since then an additional two phase-one trials have started as well as the
first phase-two trial which began in late 2005.
All of these involve products developed in internationally collaborative
ventures and are being tested at trial sites co-funded by SAAVI.
This made South Africa the first developing country to be running multiple,
multi-centre trials and also the first to test a clade C vaccine.
Currently there are four phase one trials under way as well as two phase two
trials including one for a therapeutic vaccine.
I believe a third phase tow trial will commence this month and that a phase
two-B trial is planned for the near future, subject to regulatory approval.
In terms of locally developed products, SAAVI has two developed by
researchers at the University of Cape Town (UCT) that are currently being
manufactured and could go into trials in 2007.
The initiative has also recently announced its latest three-year funding
cycle.
This as advertised via a competitive request for proposals process and the
proposals received were subjected to an extensive local and international peer
review process.
Final funding decisions were made and the new funding cycle commenced as of
April 2006 with projects and programmes receiving funding for the period 2006
to 2009.
This represents an important refocusing and planning process to ensure the
initiative keeps on track in terms of its goals.
Funding has been granted for new promising areas in the basic science of
vaccine development for expanded clinical trial site development as well as for
community involvement research.
I understand that areas like intellectual property, the animal work, data
management and manufacturing issues have been identified as core support
services which must receive ongoing funding.
I believe that this exercise has afforded the opportunity of tightly
consolidating progress to date and strategically planning for future
developments in the field to build on SAAVI's strategic strengths.
I am informed that the number of principal investigators receiving funding
grants has increased to 22, with a dramatic increase in the proportion of black
and of female investigators.
Furthermore funding has been allocated to developing clinical infrastructure
in historically disadvantaged institutions and in rural areas, with the number
of clinical trial sites doubling from three to six encompassing six of the nine
provinces of South Africa.
This will allow many more South Africans to participate in the search for an
effective vaccine.
Finally, the community and behavioural science components of the research
programme have been strengthened as SAAVI moves quickly to phase two and three
clinical trials of HIV vaccines with large numbers of participants over the
next few years.
This is all almost unprecedented progress and makes SAAVI a leading
biotechnology initiative in the developing world, if not in the developed
world.
The Directorate, investigators, local and international advisors and funders
are all to be congratulated on this tremendous work achieved thus far.
However, it is not only time to sit back and congratulate each other. We
need to keep our sites firmly on the prize of an effective vaccine to stop this
epidemic in its tracks.
I thank you and wish you well in your ongoing work.
Issued by: Department of Health
19 July 2006
