Enreca Health > News > One day you'll do the ...
2009-05-26
One day you'll do the wrong experiment and then discover the AIDS vaccine...
AIDS Vaccine meeting, 19 May 2009, Alexandersalen.
When researchers, eventually, will discover the AIDS vaccine will it be due to sheer luck or to a rational and meticulous master plan for vaccine design? That was one of the provocative questions that Professor Jens Lundgren, asked at this meeting on AIDS vaccine development. Dr. Emmanuel Cormier, Human Immunology Manager, with The International AIDS Vaccine Initiative (IAVI) responded that you need to invest money and brain capacity in order to push luck in your favour. And we will need luck to find the prophylactic or therapeutic vaccine that can either prevent the infection, protect progression of the disease and reduce transmission. The motor behind the epidemic is still running and we need a vaccine to help stop the spread of HIV and end AIDS as Emmanuel Cormier stated.
There have been several waves of vaccine development assays and many AIDS vaccine candidates have been developed. Three have reached final stage testing and two of these have proven not to have an actual effect on the human immune system and has ended with the depressing headline ‘no efficacy'. But one of the most striking messages of this meeting -co-organised by AIDS Fondet, ENRECA Health and AIDSNET - was that despite of the lack of success so far all researchers involved in this areas seem to stay committed and optimistic. ‘It is not a question of ‘if' but ‘when' we will find the vaccine' Jens Lundgren noted although making sure not to say anything about a timeline, and Professor Lars Østergaard, Aarhus University hospital said that in his group they kept on saying to themselves ‘impossible is nothing', meaning we have to keep on trying. Anders Fomsgaard, Head, Virus Research and Development, Statens Serum Institute, added on to the controlled, rational optimism by sharing results from his research on DNA vaccines which could optimise the genes and the delivery system. His research is conducted as a part of an EU consortium and they have tested their product on 12 HIV positive individuals in Denmark. Although, they are not close to releasing a vaccine candidate, the results are soon to be published in the journal AIDS and the assay will soon be taken to Guinea Bissau and tested at the at the Simau Mendes Hospital within the Bandim Health Centre.
Are we asking the right question?
‘Mother nature is teaching us a lesson' said Frans van den Boom, Vice
President, IAVI, pointing to the fact that the AIDS virus is mutating so
quickly that we still have been unable to have a scientific break through in
vaccine research. Jens Lundgren,
Director, Copenhagen HIV Programme, asked whether all the failures and all the
‘no efficacy' warnings should be used as an inspiration for researchers to
re-evaluate our knowledge claims. Instead of pushing for phase 3 trials of
unpromising candidates or pursuing trials (as in Thailand) that lack scientific
evidence, we need to understand the initial questions better. Researchers must
also come to a better understanding of of protected immunity, of how to measure
immunity response in a clinical trial so that we can avoid these costly trials
that so far has brought little success to the field. Emmanuel Cormier agreed
that IAVI, which focuses specifically on the development of a prophylactic
vaccine, is currently in the process of revisiting the basic hypothesis in
order to find new routes for research. Frans van den Boom claimed that
researchers have gathered good evidence that suggest that an AIDS vaccine is
possible and even that the field of AIDS vaccine research has been revitalised
and reenergised by this need to shift focus from development towards discovery research, focussing on solving some of the
fundamental questions that remain.
Why do citizens volunteer into research trials
in poor countries?
Since the
1990'ies medical and pharmaceutical research, private as well as public, has
increasingly been globalized in the sense that more trials are conducted in
poor localities. The trend is that more trials are now being conducted in Sub
Saharan Africa, Asia and Eastern Europe and less in the United
State and Western Europe and very few
if any in the Middle East. Another trend is
that non-governmental (NGOs) organisations are now included as research
facilitators, some have even specialised in delivering full trials set ups to
the researchers. Why? ‘It's faster, cheaper
and easier!' said Birgitte Bruun, PhD student, London School of Hygiene and
Tropical Medicine and Institute of Anthropology, University of Copenhagen,
as well as former consultant with AIDSNET. For trials that deal with diseases
that are more widespread in developing countries it also has the obvious reason
that it is better to conduct trials in the settings where the eventual vaccine
or pharmaceutical product will be used.
The global picture is that it has not been difficult to recruit volunteers to participate in these trials. Even though medical research has a heavy history with unethical trials, and even though rumours around AIDS, its origins and ARVs are know to run fast, many people want to be parts of these trials. To understand why and to discuss what lab researchers should know about people at the other end of the trials, the organisers had invited Birgitte Bruun to share some preliminary results of her research on trial ethics from study participants' perspectives in Zambia.
She asked how researchers and NGOs as those with power and knowledge can address the risk of exploiting poorer and less educated research participants. Who benefits from globalized research? To what extent is local research capacity enhanced, including capacities of ethical review committees in low-income countries?
She found that it had been surprisingly difficult to access information on on-going medical trials in Zambia but estimated that most trials are on HIV (microbicides, VCT, etc.) and that most HIV trials target women (especially now that the large male circumcision trials are ended). She argued that people she had interviewed entered the trials; some passively guided but most actively and eagerly, for diffuse images of opportunities. Participation in a study was perceived as an opportunity for jobs, social position education, rather than for reasons of altruism. People are in it for the money and some manage to make a career out of being a study participant by starting to recruit new participants, by creating their own NGOs, women's groups that e.g. produce of bags to be sold in conjunction to the product. Some of these bags were sold at this meeting in Copenhagen adding a new nuance to the analysis of global and local connections.
According to Birgitte Bruun, ethical concerns and fear of exploitation was not a prominent concern among her informants. Even though they sometimes worried about the equipment being used (could it be infectious?) they ask few questions. She called for an on-going moral reflection by researchers, a reflection that included on the involvement of stakeholders so that it is not only about researchers getting their fame but rather about everybody gaining from globalized research. She also called for better trial site registration so that information is shared and so that it becomes easier for local researchers to be involved in a meaningful way.
Maria Vang Johansen, DBL-Life, University of Copenhagen, reminded the audience of the fact that the first ethical imperative for researchers working with trials is respect for the participants.
At the end of the meeting, Lars Østergaard, chair, AIDS Fondet, thanked the audience of approximately 65 AIDS activists, researchers and policy makers for their active participation. He noted that no one today said that it is impossible to develop an AIDS vaccine and encouraged IAVI as well as the various Danish groups with partners to carry on the work.
Lise Rosendal Østergaard
