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Some describe malaria as Africa’s ‘silent tsunami’. Yet the distressing statistics of 1 million malaria deaths and over 500 million malaria cases per annum are audible enough to many — as are the economic costs, estimated at US$12 billion per annum.
Efforts to treat and prevent malaria are failing mainly because the malaria parasite and mosquitoes are increasingly resistant to drugs and insecticides. A malaria vaccine could help; vaccines are the backbone of public health interventions, especially in poor countries, where they help contain or even eradicate leading killers such as polio, measles and tetanus.
But malaria researchers in Africa must not sit back and simply wait for a malaria vaccine to appear. They must become fully familiar with the scientific advances, and establish early collaborative links with malaria vaccine developers.
At the same time, African malaria research institutions, in collaboration with stakeholders, should prepare trial sites, train essential personnel and build appropriate infrastructure.
Without such local commitment to strengthening malaria vaccine research capacity, an effective malaria vaccine may never be produced and tested, or, if it is, may not be the one that benefits those Africans who need it most.
For example, pharmaceutical companies might become more interested in potentially lucrative malaria vaccines for tourists than in those for the inhabitants of developing countries.
It is already clear that vaccines targeting the parasite entering human red blood cells, which may prevent an infection developing into the disease, as well as vaccines that block parasite transmission, which could protect vulnerable communities, have not attracted much interest from drug companies.
Because African institutions lack the necessary facilities and expertise, malaria vaccine researchers in developed countries have a near-monopoly on early research, pre-clinical research and early phases of clinical trials. This headstart helps such researchers to publish in respected scientific journals, to gain academic accolades and to patent products quickly.
As a result, African researchers and study participants are often out in the cold. Researchers in Africa, for instance, may be forced to take on the later stages of research, which are highly demanding but less rewarding academically. Along with study participants, they may be excluded from patent negotiations. And the end product may never become available to people on whom it was tested.
Although there are many malaria research institutions in Africa, few have the capacity to undertake vaccine trials. In 1997, Tanzania’s National Institute for Medical Research (NIMR) assessed 29 potential vaccine-testing centres in 20 countries across sub-Saharan Africa. Most fared poorly, emerging as unprepared for malaria vaccine trials.
Besides the need to recruit those on whom the trials are to be carried out, setting up malaria vaccine trials requires many specialists, such as molecular biologists, immunologists, biochemists, parasitologists, entomologists, epidemiologists, biostatisticians, data managers, sociologists, behavioural scientists and public health experts.
Local malaria researchers are more familiar with subtle biological issues, such as malarial seasonality, as well as cultural ones, which they will have encountered throughout field trials. So African scientists should be at the centre of the continent’s vaccine research.
Yet the NIMR survey revealed large gaps in human resources, despite investments in long-term professional training from agencies such as the United Nations Children’s Fund (UNICEF), the United Nations Development Programme, the World Bank, and the World Health Organization’s Special Programme for Research and Training in Tropical Diseases.
‘African researchers should play key
roles in vaccine research’
Photo Credit (Catherine Brahic)
The gaps are there because demand is huge and growing, and trained researchers often move on to new posts.
African personnel should also play key roles both in the research and later trial phases. Unfortunately, however, few are experienced at preparing research proposals and protocols, mobilising money, acting as consultants, networking with the scientific, health and donor communities, or liaising with policy and decision makers.
In this context, a major challenge is familiarising African malaria researchers with the ‘good clinical practice’ guidelines used by the pharmaceutical industry. Unless these are strictly followed, clinical data will not be recognised internationally — resulting in considerable intellectual and financial waste.Minding the ethics
African researchers must, above all, ensure that the planned trial is appropriate for the participants.
This is a tall order. But it is essential with malaria vaccines, since vaccine candidates are intended for various eventual applications. For example, it would be unethical to test vaccines intended for short-stay tourists on vulnerable African communities.
To add to the challenge, existing international ethical review guidelines may give conflicting views.
Each study should be approved by an ethics review committee. Unfortunately, in many African research institutions this process is still weak. African researchers must ensure ethics review committees are effective and that they address conflicts of interest.
In my experience, concerns expressed by the senior African scientist involved in a trial are not always adequately addressed by those leading the trial. And quite often, the same is true for the concerns of the rest of the research team, as well as those of the communities that are the subject of the research.
Researchers from developed-country institutions are often the principal investigators in malaria vaccine trials, while their national counterparts play less intellectually rewarding roles. But these principal investigators may lack the qualifications, competence and experience needed to meet host country regulations.
Because of this, national staff usually take charge of obtaining informed consent, and medical care is frequently delegated to junior nationals, who may not be fully aware of the current literature or the relevant background data.
Such an imbalance between the contributions of developing and developed-country scientists means that national research priorities and agenda will be set by visiting experts, and may not meet a country’s needs. Such a situation can also perpetuate a dependence on external expertise, and is unlikely to prepare nationals to take the process to the point of deploying the licensed end product.
Furthermore at the end of a trial, researchers from the developed world usually move on to greener pastures. There is a rush to publish, as though the main beneficiaries of the research are other researchers, rather than those suffering from the disease.
The rewards for participating in a research project should clearly be commensurate with the inputs of the individual concerned. Yet often, senior researchers from the sponsor country are cited as co-authors of rezsearch papers, even if they have only made minimal contributions, while contributors from a host country are excluded.
Another responsibility on researchers is to inform the participants, the local community, the district health management team, the ministry of health, the donor community, the relevant NGOs, the local and national press and media about their findings. Too often, however, the results are presented in confusing scientific jargon.
To avoid this, a communications specialist may need to be engaged to help with presenting the information intelligibly to the groups that need to hear it.Fostering skills
A mother waits with her child’s
vaccination book (Tanzania)
Photo Credit (TDR/Crump)
Over a hundred antigens are vying to become malaria vaccine candidates. And there are many immunological methods for evaluating trials. Yet, so far, there is no standardised protocol for evaluation. Researchers need to establish a pertinent gold standard, standard operating procedures and good laboratory practice. Molecular biology, immunology and vaccinology advance quickly, and African scientists will need to keep updating their training.
In Africa, many scientists work in isolation, few have research mentors, and promising researchers are often asked to manage research institutions early in their career before they have gained appropriate experience.
These scientists need better resource management and leadership skills. They also need skills in research ethics, networking, and disseminating and using research results. In an African setting, these skills are essential to proper institutional management.
Since the pharmaceutical industry lacks interest in developing malaria vaccines for Africa, the public sector has established grants to new non-governmental institutions.
But these institutions then become alternative sponsors who must take on the pharmaceutical industry’s normal roles, including preparing standard operating procedures and trial protocols, and arranging legal expertise, insurance and indemnity coverAlternative sponsors must also appoint clinical monitors — the principal communication link between sponsor and investigator — whose job is to ensure trials are well run. Africa needs to recruit and train more African clinical monitors. Building all this expertise in Africa is a major challenge, needing good collaboration between developed and developing countries.