Note from the Africa Office

Dear readers,

It is a pleasure to present to you the current issue of the EDCTP newsletter featuring the progress and activities of EDCTP over the second quarter of 2010. The Partnership has continued to soar with activities matched with measurable progress, and a snap shot of these are highlighted in the recent release of the EDCTP 2009 Annual Report. An update on the new projects adding to the rapidly growing project profile is also covered in this issue. Moreover, a glace of one of the recently concluded projects on custom made treatments for HIV-infected children, lead by Professor Chifumbe Chintu from Zambia is cited. EDCTP also proudly recognises the outstanding achievement of one of its grantees, Professor Marleen Temmerman who was awarded the British Medical Journal’s group award for lifetime achievement. Additionally, you are encouraged to check out the two new calls, one on the evaluation of the impact of clinical trials in Africa and the second one, a repeat Member States Initiated call. Both calls will be launched mid-August 2010.

The recently concluded EDCTP Connecting the Chain II, meeting held in Brussels on 9 June 2010, whose theme was ‘Linking Research and Development’ features in this issue. EDCTP extends special thanks to all its stakeholders who participated in making this meeting a great success.

EDCTP has continued with site visits to EDCTP-funded projects and pursuing dialogue with policy makers in the countries where the research work is actually done. In the last quarter, an EDCTP team visited institutions in Rwanda and met with various officials as covered in this issue. Furthermore, an EDCTP delegation had a meeting with the African Union Commission Chairperson, an activity aimed at mutual sharing of information and strengthening strategic collaboration between the African Union and EDCTP.

As EDCTP continues to chart its course forward, the current period represents an important landmark for the organisation. This is a period of reflection, consolidation and continued harnessing of feedback and views of all our valued stakeholders. With this note I wish to draw your attention to the European Commission independent review panel evaluation report on the end-of-term review on the EDCTP programme which is available both on the EDCTP and European Commission websites. I also would like to take this opportunity to recognise and appreciate the enthusiastic support of all our stakeholders for participating in the ongoing public European Commission consultation.

I hope you enjoy reading this newsletter.

Michael Makanga
Director of South-South Cooperation and Head of Africa Office

Events

Connecting the Chain II: Linking Research and Development

On 9 June 2010, more than 60 representatives of European and African research organisations and Universities, policy makers, development agencies, Product Development Partnerships (PDPs), Philanthropic organisations and other stakeholders in the fight against poverty-related diseases, met at the University Foundation in Brussels, Belgium to discuss the impact of the current EDCTP programme as well as discuss its future outlook. The deliberations of this meeting focused on the health development agenda in Africa, and how to explore and bridge gaps between development cooperation and research. Read more >>

News about EDCTP Governance

EDCTP Annual Report 2009

EDCTP is pleased to announce the release of its 2009 annual report. 2009 was a very prolific year for EDCTP. This annual report features the rapidly increasing trajectory of EDCTP funded projects including the new grant scheme of European Member State Initiated (MSI) projects and the regional networks of Excellence. This report provides a snap shot of EDCTP funding in sub-Saharan Africa as of end of 2009, highlights of ongoing projects, progress on integration of projects, EDCTP constituency updates, as well as the Fifth EDCTP Forum in Arusha, Tanzania, on 12 to 14 October 2009, among other topics. Read more >>

Evaluation report of the end-of-term review on EDCTP programme released

The final evaluation report on the European and Developing Countries Clinical Trials Partnership (EDCTP) programme by an Independent External Evaluation Committee has been released. This review process, which started in July 2009, was commissioned by the European Commission aiming to deliver recommendations on the continuation of the programme after September 2010, when the EDCTP current constitution officially ends. Read more >>

News about Calls and Grants

Announcement of calls

The following calls for proposals will be launched in August 2010:

Call: Evaluating the impact of clinical trials in Africa

The purpose of this grant is to gain comprehensive insight into the impact of clinical trials on health services in sub-Saharan Africa, especially with regard to the quality of those services delivered to women and/or children.

In this call, emphasis is placed on evaluating the impact from the perspective of patients; health professionals; the community; and, public health services at the sites in sub-Saharan Africa, where the clinical trials are being conducted.

Call: Member States Initiated projects

European Member States often independently fund projects that fall within the remit of EDCTP. The purpose of this grant is for EDCTP to provide funding and added value to these initiatives by acting as the locus of integration for various projects and programmes that have been independently
initiated and or funded by Member States.

These calls will be published in August on www.edctp.org.

Calls open for application

Call for experts

Funded projects

EDCTP is pleased to announce funding of the following projects:

Call: Support of clinical trials, capacity building and networking in new and improved diagnostics for tuberculosis

The evaluation of Mycobacterium tuberculosis specific host cytokine signatures in whole blood culture supernatants as diagnostic biomarkers for active TB infection
Project Coordinator: Gerhard Walzl
Budget: € 4,387,203 (€ 3,349,570 EDCTP)
Duration of project: June 2010-June 2013
African countries involved: Ethiopia, The Gambia and South Africa
Cofunding partners: BMBF (Germany), EU Research (Germany), Leiden University (Netherlands), LSHTM (United Kingdom), Makarere University (Uganda), Max Planck Institute (Germany), Medical Research
Council (United Kingdom), NACCAP (Netherlands) and Stellenbosch University (South Africa)

Evaluation of new and emerging diagnostics for childhood tuberculosis in high burden countries (TB CHILD)
Project Coordinator: Fred Lwilla
Budget: € 3,309,885 (€ 1,532,586 EDCTP)
Duration of project: May 2010-May 2013
African countries involved: South Africa, Tanzania and Uganda
Cofunding partners: AISPO-Nsambya Hospital (Uganda), Federal Ministry of Education and Research (BMBF) (Germany), Foundation for Innovative New Diagnostics (FIND) (Swtizerland), Klinikum der
Universitat Munchen, Institute for Medical Bioinformatics (Germany), Ministry of Foreign Affairs (Italy), San Raffaelle del Monte Tabor foundation (Italy), Swiss Agency for Development and Cooperation (SDC) (Switzerland) and Swiss National Science Foundation (Switzerland)

Evaluation of multiple novel and emerging technologies for TB diagnosis, in smear-negative and HIV-infected persons, in high burden countries (the TB-NEAT study)
Project Coordinator: Keertan Dheda
Budget: € 7,265,164 (€ 2,615,164 EDCTP)
Duration of project: May 2010-May 2013
African countries involved: South Africa, Tanzania, Zambia and Zimbabwe
Cofunding partners: Delft Imaging Systems BV (Netherlands), Federal Ministry of Education and Research (BMBF) (Germany), Foundation for Innovative New Diagnostics (FIND) (Switzerland), Klinikum der Universitat Munchen, Institute for Medical Bioinformatics (Germany), Medical Research Council (United Kingdom), Netherlands Organisation for Scientific Research (NWO) (Netherlands) and Swedish International Development Cooperation Agency (SIDA) (Sweden)

Call: Identification and Strengthening of Joint Programme Activities

Integrated training activities and IT infrastructures to improve capacities in eastern Africa area
Project Coordinator: Anders Sönnerborg
Budget: € 282,908
Duration of project: May 2010-May 2013
African countries involved: Ethiopia, Kenya and Tanzania

Improved diagnostic and prognostic tools to combat tuberculosis in high endemic areas - from bench to clinical trials
Project Coordinator: Thomas Schoen
Budget: € 213,087
Duration of project: April 2010-April 2013
African countries involved: Ethiopia and Guinea-Bissau

Call: Establishment and strengthening of African National Ethics Committees or Institutional Review Boards

Strengthening ethical review capacity of the Joint Clinical Research Centre-IRB and collaborating IRBs in North and Western Uganda
Project Coordinator: Peter Mugyenyi
Budget: € 49,759
Duration of project: May 2010-May 2012
African countries involved: Uganda

Strengthening of the National Ethics Committee in Gabon and creation of a Central African Ethics Committee Network (CAEN)
Project Coordinator: Pierre-Blaise Matsiegui
Budget: € 49,995
Duration of project: May 2010-May 2013
African countries involved: Gabon

Establishment and training of an Institutional Review Board (IRB) at the Kigali University Teaching Hospital (KUTH) to strengthen the ethical review capacities in Rwanda
Project Coordinator: Stephen Rulisa
Budget: € 47,850
Duration of project: May 2010-May 2011
African countries involved: Rwanda

Strengthening the capacity of UL-PIRE IRB
Project Coordinator: James Kollie
Budget: € 47,740
Duration of project: April 2010-April 2012
African countries involved: Liberia

Training and resources in research ethics evaluation for Africa
Project Coordinator: Dominique Sprumont
Budget: € 49,350
Duration of project: March 2010-March 2011
African countries involved: Mozambique, Nigeria and Senegal

Call: Senior Fellowships

Building research infrastructure and capacity to implement an HIV/STD prevention trial in post conflict Liberia
Project Coordinator: Stephen Kennedy
Budget: € 198,776
Duration of project: May 2010-May 2012
African countries involved: Liberia

Evolution of neutralizing antibodies among acute to early HIV subtype C infected individuals in Botswana: one year longitudinal study
Project Coordinator: Takafira Mduluza
Budget: € 199,870
Duration of project: May 2010-May 2012
African countries involved: Botswana and Zimbabwe

A cluster-randomised controlled trial to assess the impact of combined strategies (impregnated bed nets plus home management of malaria oriented by Rapid Diagnosis Test) on severe malaria morbidity in children aged 6 to 59 months in Burkina Faso
Project Coordinator: Alfred Tiono
Budget: € 199,956
Duration of project: April 2010-April 2012
African countries involved: Burkina Faso

Evolution of HIV-1 ARV drug resistance mutations in the ART naïve during therapy; threshold frequency levels and linkage context associated with treatment failure in Uganda
Project Coordinator: Jonathan Kayondo
Budget: € 198,054
Duration of project: March 2010-March 2012
African countries involved: Uganda

Career development and strengthening institutional capacity for clinical research in TB at the Faculty of Health Sciences in Brazzaville
Project Coordinator: Sunny Okhaide
Oyakhirome
Budget: € 200,000
Duration of project: April 2010-April 2012
African countries involved: Cameroon and Gabon

The risk of pulmonary tuberculosis associated with intestinal helminth infection among children at two tuberculosis vaccine trial sites in sub-Saharan Africa
Project Coordinator: Mark Hatherill
Budget: € 198,055
Duration of project: April 2010-April 2012
African countries involved: Kenya and South Africa

Erratum
In the April 2010 newsletter, there was a mistake in the duration of project in the project ‘Integrating capacity building and networking in the design and conduct of Phase I and II clinical trials of viral vectored candidate malaria vaccines in East and West African children and infants (Vectored Malaria Vaccines)’ (Egeruan Babatunde Imoukhuede). The correct duration of project is February 2010-February 2013.

Focus on EDCTP grantees

Prof. Marleen Temmerman receives the BMJ’s Group Award for Lifetime Achievement

Professor Marleen Temmerman, a Professor of Obstetrics and Gynaecology at the University Hospital in Belgium, has been honoured with the Lifetime Achievement Award of the British Medical Journal (BMJ) at the ceremony that took place on 10 March 2010. This award is conferred upon an individual who has, over his or her working lifetime, made a unique and substantial contribution to improving health care, whether in clinical practice, health services, public health, health policy, medical education, or medical research. The jury selected 10 nominations from the 117 proposals that were put forward, where Prof. Temmerman exceeded all candidates and was selected the winner for her commitment to improving women’s reproductive and sexual health and rights, especially in Africa.

EDCTP is proud to have Prof. Temmerman as a beneficiary of its funding both as principle investigator and as collaborator in various EDCTP-funded researches, and warmly congratulates her for this important achievement.

More information on the BMJ’s Group Award: http://groupawards.bmj.com

Project at a glance: Custom made treatments for HIV-infected children (Prof. Chifumbe Chintu, Zambia)

Lack of appropriate antiretroviral formulations for HIV-infected children has been one of the major constraints to scaling up of treatment in HIV-1 infected children in resource limited countries. Triomune Baby/ Junior is a fixed dose combination of stavudine (d4T), lamivudine (3TC) and nevirapine (NVP) in a new formulation specifically developed for children.

Professor Chifumbe Chintu and his team in collaboration with the Medical Research Council (United Kingdom), Radboud University Nijmegen (Netherlands), University of Padova (Italy), University of Zambia and University Teaching Hospital Zambia, with an EDCTP grant studied the appropriate dosing of, and adherence to Triomune Baby/Junior in the project entitled ‘Children with HIV in Africa-Pharmacokinetics and adherence of Simple Antretroviral Regimens (CHAPAS-1 Trial)’. This project, which started in November 2005, had a major breakthrough with preliminary Pharmacokinetics (PK) data being shared with the Food and Drug Authority (FDA) of the United States of America. Read more >>

Meetings and visits

Meeting with the African Union Commission Chairperson

On 26 April 2010, the EDCTP Executive Director, Professor Charles Mgone; the High Representative, Dr Pascoal Mocumbi; and the Director of South-South Cooperation and Head of Africa Office, Dr Michael Makanga visited the African Union Commission in Addis Ababa, Ethiopia. During this visit the EDCTP delegation had a meeting with the African Union Commission Chairperson, His Excellency Mr Jean Ping. Also in attendance were: the African Union Commission Director for Social Affairs, Dr Olawale Maiyegun; Chief of Staff of the Bureau of the Chairperson, Mr John Shinkaiye; Deputy Chief of Staff of the Bureau of the Chairperson, Mr Pierre Moussavou and the of Ambassador of Mozambique in Ethiopia, Mr Manuel Lubisse. Read more >>

EDCTP site visit to Kigali, Rwanda

Rwanda is one of the African countries with increasing number of EDCTP-funded projects from 2005 to 2010. Currently, the following projects are either ongoing or recently completed:

Strengthening of the Rwanda National Ethics Committee (led by Dr Justin Wane)
Establishment and Training of an Institutional Review Board (IRB) at the Kigali University Teaching Hospital (KUTH) to Strengthen the Ethical Review Capacities in Rwanda (led by Dr Stephen Rulisa)
Project Ubuzima: Preparing for Phase III vaginal microbicide trials in Rwanda and Kenya : Preparedness studies, capacity building, and strengthening of medical referral systems (led by Dr Van der Wijgert and Dr Kishor Mandaliya)
The Monod Project multi-centre trial on simplifying paediatric ART (led by Dr Valeriene Leroy and Dr Corine Karema)
Safe and efficacious artemisinin-based combination treatments for African pregnant women with malaria (led by Prof. Umberto D’Alessandro)
Evaluation of 4 artemisinin-based combinations for treating uncomplicated malaria in African children (led by Prof. Umberto D’Alessandro)
Characterisation of novel microbicide safety biomarkers in East and South Africa (Dr Justin Ntirushwa). Read more >>