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 Head of the Africa Office’s note News about Calls and Grants
Focus on EDCTP grantees
Events
Meetings and visits
EDCTP staff visit to clinical trial sites in Tanzania and Malawi WHO-EDCTP collaboration on national regulatory framework for Africa
Announcements
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| Head of the Africa Office’s note | ||||||
The year 2006 has come and gone; some may say too quickly. Nevertheless, as the year was drawing to an end, EDCTP relentlessly continued rolling out various activities some of which are reported in the current issue of the newsletter. These include the stepping up of site visits whereby in the last quarter of the year among the places visited included Tanzania and Malawi. As usual during the visits, the Secretariat staff accompanied by the DCCC members met with various African leaders (political and scientific) to advocate for the acceleration of R&D to fight HIV/AIDS, malaria and tuberculosis. Also reported in the current issue are the capacity development activities and advocacy that EDCTP is pursuing including in collaboration with other partners such as the World Health Organisation (WHO), African AIDS Vaccine Programme (AAVP) and International AIDS Vaccine Initiative (IAVI). These include capacity development to support the regulatory framework through the Global Network Training conducted in collaboration with WHO and setting up of priorities and a common advocacy for R&D of HIV vaccines in Africa conducted in partnership with WHO, AAVP, IAVI and other partners. We are very happy to inform the readers of the achievements of two of our Senior Fellows. In the issue we feature the success of Dr Alexis Nzila, an EDCPT Senior Fellow, from Kenya Medical Research Institute (KEMRI) who was awarded the prestigious Royal Society Prize for advancing discoveries through his work on anti-folate drugs in the treatment of malaria. We are also very proud of Dr Abraham Alabi and his team who have successfully organised a one-week training course on an “in-house” HIV viral load assay for scientists from the West African sub-region. This followed the testing, optimisation and evaluation of the assay after Dr Alabi was awarded an EDCTP Senior Fellowship for that purpose. On 1 December, to mark the World AIDS Day, EDCTP in collaboration with the Bill & Melinda Gates Foundation launched a 20 million Euro grant for capacity development to conduct clinical trials of preventive HIV vaccines in Africa. This and the news on the Third EDCTP Forum that was held in Stockholm in October this year are all reported in the current newsletter. Indeed 2006 was a hectic and successful year for EDCTP. We sincerely thank all of you who have helped us make 2006 a very sucessful year and as we welcome 2007 we wish all our readers, stakeholders and partners a very successful and prosperous new year.. |
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| News about Calls and Grants | ||||||
EDCTP is pleased to announce fundings for the following proposals:  |
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EDCTP/BMGF 20 M Euro grant to develop HIV vaccines trial capacity in Africa To address the urgent need for developing and preparing sites to conduct HIV vaccine trials in countries seriously affected by the epidemic, the European and Developing Countries Clinical Trials Partnership (EDCTP) and the Bill & Melinda Gates Foundation announce a 20 million euros joint call for proposals to fund capacity building for HIV vaccine trials in sub-Saharan Africa. Each applicant may request up to €4 million over a three-year period. The call is part of the collaborative effort proposed by the Global HIV Vaccine Enterprise. The initial focus of the funding is for the preparation of sites to be able to conduct phase II clinical trials of HIV candidate vaccines, but where appropriate, it may also be used to conduct trials. The funded projects are expected to provide a clear research plan, identifying the specific research activities in preparation for future trials as well as a training plan to ensure success in conducting clinical trials and sustainable Participation of the private sector is strongly encouraged, however, all project coordinators must be individuals working in public institutions who are residents of either EDCTP-EEIG member states or sub-Saharan African countries. For further details and to view the call text, including the information on how to submit applications, please visit the EDCTP website at: www.edctp.org. The deadline for submission of applications is 31 March 2007.
The EDCTP is supported by the European Union. List of the EDCTP-EEIG member states List of the sub-Saharan African states |
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| Focus on EDCTP grantees | ||||||
An EDCTP Senior Fellow receives a prestigious award for malaria research Dr Alexis Nzila, an EDCTP Senior Fellow, from the Kenya Medical Research Institute (KEMRI) was awarded a prestigious Royal Society prize for advancing discoveries into antifolate drugs for the treatment of malaria. Dr Nzila obtained an EDCTP fellowship in 2004 to work on the understanding of the mechanism of the antimalarial piperaquine resistance. The current award, The Royal Society prize, is in recognition of his work on the mechanism of antifolate resistance and the discovery of antifolates drugs for malaria treatment. Dr Nzila has developed an innovative approach by drawing parallels between malaria and cancer cells. Cancer cells and the malaria parasites multiply readily and rely on the availability of folates to grow. By comparing the role of folates in cancer cells to their function in malaria, Dr Nzila was able to better understand their role in malaria. Fansidar (Suphadoxine-Pyrimethamine), an antifolate drug, is used to inhibit the production of folate molecules to prevent malaria from multiplying. The malaria parasite, however, can develop resistance quickly. Dr Nzila’s team found that resistance to Fansidar was a result of the parasite’s ability to change amino acids in the enzymes that this drug targets. By monitoring changes in the enzyme genes, the researchers found they could predict whether a parasite would be sensitive or resistant to Fansidar. Using information from cancer, Dr Nzila’s research team has demonstrated that the resistance to Fansidar can be reversed by using a cheap and non-toxic old drug known as probenecid. This drug has been successfully used in combination with Fansidar to treat malaria in children in Nigeria. Dr Nzila also has discovered that some antifolates anticancer drugs, such methotrexate and aminopterin could be used at low and non-toxic doses in combination with folate vitamin to treat malaria. Dr Nzila intends to use the £60,000 award grant to explore the potential of these 2 anticancer antifolate drugs as antimalarials. Dr Nzila said: “I am thankful to the EDCTP for supporting me at a critical time when my research work had no funding. Had it not been for EDCTP, I would possibly not be where I am today.” Dr Nzila also thanks Pfizer, the Royal Society and EDCTP for creating special schemes aimed at supporting African scientists to work in Africa. He added” There will not be a solution to African problems without the involvement of the African themselves, and malaria is an African problem.” |
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Workshop on HIV viral load assay As part of a two-year EDCTP Senior Fellowship awarded in 2004 to Dr Abraham Alabi, his team organised a one-week training course on an “in-house” HIV viral load assay for scientists from the West Africa sub-region. In all, more than 50 scientists applied for the course out of which 10 were selected based on merit and willingness to participate in a proposed multi-centre evaluation of the assay. This is vital to achieving a possible long-term objective of a wider use of this simple assay in resource-poor settings for monitoring HIV-infected patients on therapy and in the evaluation of therapeutic vaccines when available. The training workshop was hosted by the Medical Research Council (MRC) laboratories in Banjul, Gambia. Those who participated in the workshop and successfully attended the training course include Mrs Marie-Yolande Alloue-Borget of Project RETRO-CI, Abidjan, Cote d’Ivoire; Ms Coumba Toure Kane from Laboratoire de Bactériologie-Virologie, Dakar, Senegal; Mr George Ikomey from the Centre for the Study & Control for Communicable Diseases, University of Yaoundé, Yaoundé Cameroon; Mr Simeon Aidoo from Noguchi Memorial Institute for Medical Research, Accra, Ghana; Ms Sarah Gabadi from Innovative Biotech Ltd, Keffi, Nasarawa State, Nigeria; Mr Olumuyiwa Babalola Salu, Human Virology Laboratory, Nigerian Institute of Medical Research, Lagos, Nigeria; Mr Zacarias José Da Silva, Bandim Health Project, Bissau, Guiné-Bissau; Mr Momodou M. Jallow, National Health Laboratory Services, Royal Victoria Teaching Hospital (RVTH), Banjul, Gambia; Mr. Eliman Jobe, National Health Laboratory Services, Royal Victoria Teaching Hospital (RVTH), Banjul, Gambia; and Mrs Hannah Dada-Adegbola from the College of Medicine, University of Ibadan, Nigeria. The training involved “hands-on” practical work during which participants were put through the entire process of the HIV-1 arm of our viral load assay. These included extraction of HIV RNA from the plasma of HIV patients; reverse transcription of the extracted HIV RNA to copy DNA (cDNA); using the cDNA to set up PCR (i.e. RT-PCR step); and detection of target DNA product in a process called enzyme oligonucleotide assay (ELONA). By the end of the training the participants were happy with the assay and Dr Alabi is keen to have the assay validated on a wider scale for HIV testing in Africa. Professor Tumani Corrah, the Director of MRC Gambia and Mrs Alison Offong, The Executive Assistant to the Unit Director also attended the workshop. |
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| Events | ||||||
The third EDCTP annual forum, 9-11 October 2006 The Third EDCTP Annual Forum was held from 9 to 11 October 2006 at the headquarters of the Swedish Society of Medicine in Stockholm, Sweden. Around 140 participants gathered at this beautiful venue to discuss various topics around the theme of ‘Partnership and African Leadership: Challenges and Opportunities´. The forum covered items such as building capacity in scientific leadership in Africa, networking, making clinical trials cost effective and partnership and African leadership in conducting clinical trials. Experiences from the field and reports from EDCTP grantees were also presented. Lessons from the forum include the knowledge that there is great commitment for the EDCTP programme in Africa; however, more projects need to be implemented. It was also observed that the African involvement could be used to foster integration of research programmes in the north and that the need for sustainable capacity building is still great. The national programmes of the European countries that participate in EDCTP are being mobilised to achieve the objectives of Article 169. It was also noted that it is apparent that more needs to be done and that many development partners are aware and supportive of EDCTP as a tool for delivering new products to Africa, but this requires a genuine partnership with Africa. Presentations at the forum clearly reflected the progress EDCTP is making in achieving its objectives. Commitment from partners from both continents was demonstrated. The overall challenge is for EDCTP to upscale their activities and proceed on their chosen path. A full report on the forum will soon be available at the EDCTP website. Preparations are currently underway to organise the Fourth EDCTP Forum. This will take place in Burkina Faso from 22-24 October 2007. More information on this event will be presented in the next EDCTP Newsletter. |
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| Meetings and visits | ||||||
UA/AAVP regional consultation meeting on HIV vaccines R&D in Africa In the third quarter of 2006 EDCTP continued its collaborative activities with the African AIDS Vaccine Programme (AAVP). It co-sponsored an Africa Union (AU)/AAVP regional consultation on HIV vaccine research and development for Africa that took place in Addis Ababa (Ethiopia) from 25 to 26 September 2006. This followed a similar EDCTP co-sponsored sub-regional consultation on HIV vaccine research and development in Africa for the member countries of Common Market for Eastern and Southern African (COMESA) in June 2006 that was hosted by the government of Kenya. Apart from support from EDCTP, the AU Commission convened the Addis Ababa consultation in collaboration with the World Health Organisation (WHO), United Nations Joint Programme on HIV/AIDS (UNAIDS), International AIDS Vaccine Initiative (IAVI) and the United States Military HIV Research Programme (USMHRP). The objectives of this consultation were:
The consultation recommended that AU and other African economic communities should:
The EDCTP will continue to support AAVP and its partners in 2007. |
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| EDCTP staff visit to clinical trial sites in Tanzania and Malawi | ||||||
Tanzania visit Professor Charles Mgone, Head of Africa Office (HAO); Mr. Simon Belcher, Financial Manager (FM); and Dr Michael Makanga, Capacity Building Manager (CBM), made a site visit to Tanzania from the 16-20 October 2006. The team visited Kilimanjaro Christian Medical Centre (KCMC) in Moshi and the National Institute for Medical Research (NIMR) in Dar es Salaam. KCMC research site is preparing to undertake an EDCTP supported multicentre study on the rapid evaluation of moxifloxacin in the treatment of sputum smear positive tuberculosis, REMoxTB study. This study will be conducted in collaboration with Professor Stephen H. Gillespie of the Royal Free and University College Medical School Centre for Medical Microbiology in London as principle investigator Tanzanian sites are also involved with other studies including optimisation of tuberculosis and HIV co-treatment in Africa: Pharmacokinetic and pharmacogenetic aspects on drug-drug interactions between rifampicin and efavirenz; and site preparation and capacity strengthening for trials of vaginal microbicides in Tanzania and Uganda. The former has Professor Leif Bertilsson of the Karolinska Institutet as PI, and Professors Jane Sayi and Ferdinand Mugusi of Muhimbili University College of Health Sciences, Dar es Salaam as the Tanzanian investigators. The later has Professor Richard John Hayes of the London School of Hygiene as the PI and Mr John Changalucha of the National Institute for Medical Research (NIMR), Mwanza as the Tanzanian investigator. The African Malaria Network Trust (AMANET) secretariat hosted in Dar es Salaam is also running a free web-based health research ethics training project with funding from EDCTP. The EDCTP team together with the DCCC member from Tanzania, Dr. Andrew Kitua had separate meetings with several officials including Ms Henrietta Kolb, the Attaché Governance of the delegation of the European Union in Dar es Salaam; officials of the Tanzanian ministry of health including Dr Gilbert Mliga, the Director of Human Resources for Health; Dr. Zachery Berege, the Director of Health Services; Dr Bumi Mwamasage, the Assistant Director of Allied Health Training; Dr Raphael Kalinga, the Acting Director Preventive Services and Assistant Director Epidemiology and Disease Control; Dr Amos Mwakilasa, the Assistant Director for Continuing Education; Mr Chris Berry of the Department for International Development (DFID) Office; Professor Yohana Mashalla, Chairperson of the NIMR Ethics Committee; and the World Health Organisation (WHO) representative resident in Tanzania Dr Maganu.
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Malawi visit The FM and CBM made a site visit to Malawi on the 3 to the 6 December, 2006. The team visited the Blantyre malaria project and the college of medicine in Blantyre. The former is one of the five African sites preparing to undertake EDCTP funded multicentre studies involving phase II and III clinical trials investigating the use intravenous artesunate formulation that complies with international good manufacturing practice (GMP) guidelines, for treatment of severe malaria in African children. The later site has two EDCTP funded projects namely: Building and strengthening national capacities in ethical review and clinical trial monitoring in Malawi; and strengthening of the National Health Sciences Committee (NHSRC) and College of Medicine Ethics Committee (COMREC) with Dr Paul Ndebere and Professor Joseph Mfutso Bengo as principle grantees respectively. The EDCTP team had separate meetings with Dr Matshidiso Moeti, the WHO representative to Malawi, Professor Malcom Molyneux, Director Wellcome Trust Centre in Blantrye and senior collaborator/advisor of the anthropological and bio-ethics study of clinical research in Blantyre; Ms Joann Schmidt, interim director of research support centre university of Malawi, College of Medicine; Dr Wynn Chalira and Dr Aaron Glyn Sosola, registrar and deputy registrar & head of technical services respectively of the Pharmacy and Poisons Board in Malawi; Dr Charles Mwansambo, chairperson of NHSRC; and Dr Damson Kathyola, deputy director of research in Ministry of Health, among others. |
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| WHO-EDCTP collaboration on national regulatory framework for Africa: | ||||||
Global Training Network on regulatory authorisation and evaluation of clinical trials In July 2006, EDCTP and WHO signed an agreement to develop the first phase of a regulatory framework to ensure appropriate oversight of clinical trials in Africa. These activities are already underway and are aimed at addressing the lack of expertise in authorising and evaluating clinical trials; conduct of the ethical review process; and ensuring that the legal basis on health research is developed and is consistent with international standards of good clinical practice (GCP), good clinical laboratory practise (GCLP) and good manufacturing practices (GMP). Special efforts in the initial phase are targeting training on clinical evaluation, join review of clinical trials applications, joint inspection of clinical trial sites and developing an African regulators forum to exchange and share scientific, regulatory and ethical information relevant to clinical trials ongoing or planned in Africa. As part of these activities a Global Training Network (GTN) course on authorisation and evaluation of clinical trials has been developed by the WHO. About 100 participants are targeted for this training of which 63 African participants will be supported with funding from EDCTP and the Netherlands African Partnership for Capacity Development and Clinical Interventions Against Poverty-Related Diseases (NACCAP). The first training workshop took place in Ouiddah, Benin from the 11-15 of December 2006 and was conducted in French. This course focused on the evaluation of clinical trails protocols on vaccines Two other similar training courses will be conducted in English in February 2007 in Addis Ababa, Ethiopia and in June of 2007 (venue to be determined). This course has been developed for African managers of National Regulatory Authorities (NRAs), ethics committee members and national immunisation programme managers. Participation of African clinical investigators is also encouraged. For the first training in French, 23 participants from 10 countries including Algeria, Benin, Cameroon, Burkina Faso, Cote d’ Ivoire, Guinea, Mali, Rwanda, Senegal and Togo attended the meeting. Most of the participants were representatives of national or institutional ethics committees, NRAs and clinical investigators involved in EDCTP supported clinical trial projects. The training was facilitated by experts from France (Dr Pierre-Henri Bertoye and Dr Annie Leblond), Tunisia (Prof. Chalbi Belkahia and Prof. Mohamed Lakhal), WHO/AFRO (Dr Modibo Dicko and Dr Richard Mihigo) and WHO/Geneva (Mr Lahouari Belgharbi). The training was based on plenary sessions in the morning followed by working group sessions in the afternoon around the evaluation of samples of real vaccine clinical trials protocols. This training provided an opportunity for participants to be more aware of their respective tasks and duties, the importance of collaboration between IRB/NRB and NRA and also the need to share experiences and competencies across the continent.. During the training, constraints in the implementation of the institutional development plans (IDPs) that impede authorisation and evaluation of clinical trials for the respective countries were also reviewed. |
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| Announcements | ||||||
New networking tool: Project Partners EDCTP has just launched a new networking tool called Project Partners on the EDCTP website. Project Partners works through a profile search program where participants are required to create a profile for themselves. Profile details include areas of personal expertise, work history and the kind of collaboration needed. This profile is searchable by any logged in Project Partners user. When people are interested in working with each other they can send each other emails through the site to enquire about possible collaboration. This process eliminates spam and unwanted mail, as contact details are never shown without permission. The purpose of this tool is to provide both European scientists and African counterparts with an easy link to connect them with each other. The Project Partners site can be used to find the partners that EDCTP requests for different grant applications. Networking tools such as Project Partners are needed especially to help younger scientists form new scientific partnerships, and to bring European and African scientists closer together, so that long lasting collaborations can be made. Experienced scientists can help the next generation by logging into the site and offering partnerships to their younger counterparts. Project Partners can be found at www.edctp.org, please register now. |
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The EDCTP Blog EDCTP is pleased to announce the launch of the EDCTP Blog, an important tool in sharing knowledge and information for improving the understanding of poverty reduction in developing countries through health improvement of the populations. The Blog is open to anyone interested in the work of EDCTP and would like to contribute and participate in discussions related to the 3 PRD’s (Poverty Related Diseases). The blog will bring together information, news, ideas and discussions of all types of themes connected to our work and most importantly, visitors will be able to raise questions, gain knowledge and give opinions on the subjects discussed. The authors – the regular bloggers – are members of the EDCTP staff and constituencies, such as ENNP and DCCC members. From time to time we will have guest authors related (or not) to EDCTP to bring an outside view and discuss specific topics of their area. Blog visitors can contribute to increase the discussions by posting comments after registration. Please visit our blog at www.edctp.org/blog to find out more and register online to participate in the discussions. |
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