EDCTP Informational Newsletter – May 2021 Edition

EDCTP UpdateMay 2021 
Highlights·     Tenth EDCTP Forum – Call for abstracts·     EDCTP-e-Magazine May 2021 published·     Makerere awarded Honorary Doctorate to Prof. Akuffo
Contents·     New support tools for TB vaccine R&D published·     Tenth EDCTP Forum – Call for abstracts·     EDCTP e-Magazine May 2021 published·     Recent events·     Recently signed grants·     Project news·     EDCTP Fellows in times of COVID-19·     Resources·     Funding opportunities·     Upcoming events
New support tools for TB vaccine R&D published
The Tuberculosis Vaccine Initiative (TBVI) has coordinated the development of several new tools to support future TB vaccine clinical trials. These tools are to support preparations for a regulatory plan, a data management plan and clinical trial protocol synopses. Furthermore, a comprehensive registry of trial sites in sub-Saharan Africa with capacities to conduct TB vaccine studies has been made available online. EDCTP supported TBVI with an investment of €130,000.  Dr Michael Makanga, EDCTP Executive Director: “We are fully committed to highly collaborative research & development (R&D), open science and creating an enabling environment for research that is consistent with international standards and respecting good practices. These valuable TB vaccines R&D tools are of greater utility beyond TB. Our partnership with TBVI on TB vaccines R&D demonstrates our strong commitment to international collaborations that promote the exchange of knowledge and expertise between researchers, institutions, and partner organisations in Europe, Africa and globally.” Read the EDCTP news item – access the tools.
Tenth EDCTP Forum – Call for abstracts
The Tenth EDCTP Forum will take place from 17-21 October 2021 and is hosted from Maputo, Mozambique. Registration for the virtual Forum is open and free. For more information visit the forum websiteThe Call for abstracts is open! EDCTP invites you to submit abstracts highlighting an original contribution to EDCTP’s research topics and research capacity strengthening, linked to the Forum theme Equity in research for healthDeadline for submitting abstracts: 10 June 2021.
EDCTP e-Magazine May 2021 published
The EDCTP e-Magazine, 3rd Issue, May 2021 has been published on 04 May 2021. The e-Magazine is an online magazine offering background information and broader topics regarding the EDCTP programme. Topics in this issue are:·     Community engagement, a vital concern in clinical research·     A Global TB Vaccine R&D Roadmap·     EDCTP regional Networks of Excellence: achievements and new perspectives·     The EDCTP Knowledge Hub·     Collaborative clinical research studies on COVID-19 in sub-Saharan Africa
Recent events
AU-EU | R&I for Africa-Europe Cooperation | 04/05 2021 The Official Kick-Off Meeting of the Advisory Group on R&I for Africa-Europe Cooperation was held on 4 May 2021. The meeting was moderated by Maria Cristina Russo, EC RTD and focused on: ‘Africa-Europe stepped up cooperation in R&I for empowered public health systems’, ‘How to strengthen R&I capacities in Africa focusing on both regional and bilateral cooperation’, ‘Innovation & technology revolution’ and ‘Green Transition in Africa’. The meeting was attended by EDCTP Executive Director, Dr Michael Makanga.
Makerere awarded Honorary Doctorate to Prof. AkuffoAt its 71st Graduation Ceremony, Makerere University awarded Professor Hannah Akuffo (Karolinska Institute, Sweden) an Honorary Doctorate of Science for her many accomplishments and long service to the cause of promoting global health and especially health research in Africa. Prof. Akuffo also played an important role in EDCTP as Chair of the General Assembly under the first programme. Dr Michael Makanga, EDCTP Executive Director: “We congratulate Prof. Hannah Akuffo for this well-deserved recognition award for her contribution to transformative capacity development and gender equity in Africa. This recognition from a host country academic institution that has achieved significant scientific leadership bears witness to the highly impactful investments of Sida and champions of its programme like Professor Akuffo.” For more information, download the citation for Prof. Akuffo.
Recently signed grants
Innovative approaches to enhance poverty-related diseases research – 2020·     fPCV – Niger | Coordinator: Dr Rebecca Grais | Determining whether mass campaigns with fractional dose PCV10 would accelerate herd protection against pneumococcal transmission in sub-Saharan Africa Career Development Fellowships – 2020·     ACROSS | Fellow: Dr Rubina Bunjun | Assessing cross-reactive and pre-existing immunity against SARS-CoV-2 in adolescents Ethics and regulatory capacities – 2020·     BoCTRe | Coordinator: Dr Parthasarathy Gurumurthy | Botswana clinical trials regulation·     S-ROC | Coordinator: Dr Salihou Sadou | Strengthening the regulatory oversight of clinical trials in Cameroon Senior Fellowships Plus – 2019·     SEVR-SMC | Fellow: Dr Issaka Zongo | Risk of Malaria in Children Who are no Longer Eligible for Seasonal Malaria Chemoprevention (SMC) or Seasonal Vaccination in Burkinao Faso and Mali – SEVR-SMC (‘action’) Career Development Fellowships – 2019·     CORD | Fellow: Dr Edith Majonga | Characterisation of cardiac disease in adolescents with perinatally-acquired HIV infection in the antiretroviral therapy era·     IMPUG | Fellow Dr Musoke | Integrated malaria prevention in rural communities in Uganda: an implementation research·     Neuro-Empirical | Fellow: Dr Nalwanga | Neurocognitive Function among HIV Infected Infants with Severe Pneumonia Receiving Empirical Treatment for Cytomegalovirus and Tuberculosis·     RADIANT | Fellow: Dr Okunola | Selected concise host transcriptional signatures for the blood-based diagnosis of active tuberculosis in an HIV-prevalent setting (RNA-based diagnosis of TB) Clinical Research and Product Development Fellowships – 2019·     ANIM | Fellow: Mr Japhet Adomako Anim | Host organisation: European Vaccine Initiative (EVI), Germany
Project news
CHAPAS 4 | End recruitment | April 2021The CHAPAS (Children with HIV in Africa – Pharmacokinetics and Acceptability of Simple antiretroviral regimens) team has worked together for over a decade. It includes partners in Zambia, Zimbabwe, Uganda, the Netherlands and the UK. Their research focuses on improving treatment for HIV infected children in sub-Saharan Africa. The CHAPAS Team network has successfully completed 3 landmark clinical trials (CHAPAS 1, CHAPAS 2 and CHAPAS 3); The fourth trial CHAPAS 4, is evaluating second line antiretroviral treatment options in children. The first participant was recruited in December 2018, and we are pleased to announce that the 919th child was recruited just before Easter 2021, completing our recruitment. Recruitment continued during 2020, despite the challenges of the COVID-19 pandemic. Retention within CHAPAS-4 has been exceptional (only 0.05% lost to follow up), enabling the team to slightly reduce the sample size in view of slowing recruitment because of dolutegravir becoming available. This was approved by all committees in March 2021. The questions in CHAPAS 4 about protease inhibitors and a new drug for children (TAF) remain very relevant for children needing second line treatment in the future. The final patient for CHAPAS 4 was randomised on 1st April 2021. Participants will continue to be followed up, until the last patient has reached their week 96 visit, around February 2023.Reg. Science-Fellows | Project results | 2021The Medicines Control Authority of Zimbabwe (MCAZ)’s Regional Centre of Regulatory Excellence (RCORE) offered short courses to regulators and regulatory affairs professionals in the SADC region with support from EDCTP. The project Reg. Science-Fellows (Competence-based fellowship for African medicines reviewers and regulatory science professionals) supported the development of four modules for the RCORE in year 2, enabling MCAZ to offer training in medicines evaluation and registration on a cost-recovery basis. Three of the four courses were offered virtually due to the COVID-19 travel restrictions. Participants were from national regulatory authorities, academia, local manufacturers, and representatives of foreign applicants in the SADC countries, i.e. Namibia, Zambia, Botswana, South Africa and Zimbabwe. The training courses held were:1) Bioavailability and Bioequivalence (11 Nov-06 Dec 2019, Harare, Zimbabwe) with 41 participants.2) Advanced Drug Delivery Systems (May-June 2020) with 42 participants.3) Clinical trial considerations for product registration (28 Aug –04/Sep 2020) with 57 participants.4) Bioequivalence Basic Course 101 (05/Oct – 12/Nov 2020) with 58 participants from the SADC countries as well as India. Link to the Learning Management System: https://reg-science.com/learning/ SPaRCS – UWC | Webinar on pharmacovigilance and oversight | 12/05 2021In collaboration with the University of the Western Cape, the EDCTP-funded SPaRCS project (Strengthening pharmacovigilance and regulatory capacities in four Southern African countries) held a webinar on 12 May 2021 on pharmacovigilance and clinical trials oversight in sub-Saharan Africa in the era of COVID-19. The keynote speaker was Dr Helen Ndagije, Director of the Product Safety, National Drug Authority in Uganda.
PanACEA| Recruitment started | 17/05/2021The PanACEA2 Consortium is continuing its innovative programme of work on shorter, simpler and better treatments for TB. The PanACEA II programme aims to develop at least two promising TB-treatment regimens with sound prediction data for a successful phase III evaluation, and advance one new agent into phase IIB. It will take full advantage of state of the art technologies, including innovative trial designs, new microbiological markers of treatment response, pharmacokinetic-pharmacodynamic analyses and modelling techniques. As a result, drug development processes could be accelerated by several years. PanACEA II trial activities are conducted at 11 research sites in six countries (Gabon, Malawi, Mozambique, South Africa, Tanzania, and Uganda) in sub-Saharan Africa with integrated research capacity development. The project started recruitment of SUDOCU trial on 17 May 2021 in South Africa.
PANDORA-ID-NET & ALERRT | Workshop | 19-20/05/2021As part of PANDORA-ID-NET and ALERRT joint activities on Epidemics preparedness, an International workshop on “Implementation of novel laboratory diagnostics for emerging infectious diseases” took place on 19 and 20 May. In addition to the ALERRT and PANDORA, the workshop was delivered through a collaboration between the EDCTP Networks of Excellence, FioCruz, REDe, The Global Health Network (TGHN) and other international partners. The workshop aimed to provide concepts of verification, evaluation and validation strategies of novel laboratory diagnostics methods for rapid diagnosis and surveillance in new and ongoing outbreaks.LiberHetica, Berc-Luso & AfriEthique | Ethics symposium | 25/05 2021The Embassy of Good Science and the European Network of Research Ethics Committees, two large European networks of researchers and bioethics, organised a research ethics symposium with the involvement of the EDCTP-funded research ethics consortia LiberHeticaBerc-Luso and AfriEthique. The symposium “Challenges in Research Ethics Assessment – experience from Africa and Europe” took place on 25 May 2021. Several members of these consortia were also involved as moderators and presenters.
SEN-ETHICS | Webinar | 27/05/2021The SEN-ETHICS project hosted a webinar on “Ethical Issues on the response against the COVID-19 pandemic: Experts ‘Viewpoint’.” The webinar was moderated by Prof. Anta Tal DIA, President of the National Ethics Committee, Senegal.
NHLS Project ECHO | Webinar | 28/05 2021The National Health Laboratory Service (NHLS) of South Africa, hosted an online session on “Literatures Reviews – an essential step to conducting good and relevant research”. The session aimed at providing the fundamental steps to follow when conducting a literature review as part of a research project, both to assess what is already known about the subject of interest, and also to identify the gaps. EDCTP Project Officer Shingai Machingaidze participated as presenter.
IMPALA project | Kick- off meeting | 1-4/06/2021The aim of the interdisciplinary project is to develop an algorithm enhanced monitor for low-resource environments that enables health workers to timely detect criticalconditions and perform life saving interventions. The design focuses on a durable and easy to use system that makes it easier to collect vital signs like oxygen saturation, heart rate and breathing rate. One of the innovations is the use of a very sensitive pressure sensor that is put underneath the mattress for measurement of the vital signs. The signals from this and other sensors are processed by algorithms to detect changes in vital signs that may indicate serious illness hours before even highly trained healthcare workers would be able to identify the issue. The project is coordinated by the Amsterdam Institute for Global Health and Development (AIGHD) and the kick-off meeting will be held on 1,3 and 4 June 2021.
PUBLICATIONS BioStat-LAB-Africa | PublicationsThe team published results in: ·     Open Access: Jamilah Meghji ‍‍,Maia Lesosky ‍‍,Elizabeth Joekes, Peter Banda, Jamie Rylance , Stephen Gordon, Joseph Jacob, Harmien Zonderland,Peter MacPherson ‍‍ Elizabeth L Corbett, Kevin Mortimer , Stephen Bertel Squire: ‍‍Patient outcomes associated with post-tuberculosis lung damage in Malawi: a prospective cohort study·     Chest Infections Original Research: Kevin Mortimer,Maia Lesosky, Sean Semple, Jullita Malava, Cynthia Katundu,Amelia Crampin, Duolao Wang, William Weston, Dan Pope, Deborah Havens, Stephen B. Gordon and John Balmes: Pneumonia and Exposure to Household Air Pollution in Children Under the Age of 5 Years in Rural Malawi Findings From the Cooking and Pneumonia Study  GloPID-R | Priorities for COVID-19 research response and preparedness in low-resource settings | 6/05 2021Representing EDCTP in GloPID-R and as a member of the COVID CIRCLE working group, EDCTP Senior Project Officer, Jean- Marie Habarugira co-authored a Lancet Commentary highlighting the conclusions from a conference held in March 2021 focusing on COVID-19 research priorities in LMICs. ‘Priorities for COVID-19 research response and preparedness in low-resource settings’PREPARE | Publications | 25/05 2021The PREPARE project published results in an article in Vaccines as part of the Special Issue Factors Associated with Vaccine Hesitancy “Maternal Vaccination in Uganda: Exploring Pregnant Women, Community Leaders and Healthcare Workers’ Perceptions” . NEW WEBSITE CREDU| Leveraging ICT for Improved Clinical Trials and Research Management | May 2021The Uganda National Council for Science and Technology and partners implemented the Consortium for Clinical Research Regulation and Ethics Capacity Development in Uganda (CREDU) project funded in 2017 by EDCTP. The project which was concluded in June 2019, developed the Clinical Trials Information Management System (CRIMS). CRIMS aimed at harmonising standards of the in-country approval across all regulatory agencies as well setting up an online and sustainable platform for review and approval of a clinical trial. The project published its website.
EDCTP Fellows in times of COVID-19
Professor Mukhtar Prof Mukhtar is an EDCTP1 Senior Fellow and published an article on ‘The accelerating COVID-19 epidemic in Sudan‘. The article analyses the development of the COVID-19 epidemic in Sudan from the outbreak until now.
Collaborative clinical R&D onlineClinical research capacityPDFFellowshipsonline
EDCTP | Knowledge Hub: Tools and guidance for conducting clinical researchThe EDCTP Knowledge Hub is an online platform with resources for researchers conducting clinical research in low-resource settings. The platform’s tools are designed to help researchers develop research questions into a protocol, adopt gold-standard clinical data management practices, and support awareness and capacity development around data sharing. The platform is suited to all health research groups and aims to facilitate high-quality clinical research in poverty-related diseases.Visit the EDCTP Knowledge HubEDCTP | Global Roadmap for TB Vaccines R&DSee the published roadmap (PDF).For background, read the EDCTP news itemEDCTP | Guidelines for grantees – Progress reportEDCTP Guidelines for grantees on how to best use the online progress reporting facility in EDCTPgrants, EDCTP’s grant management system. Go to the publication Online Progress Report in EDCTPgrants – Guidelines for beneficiariesEDCTP | Template for Grant Agreement Annex 5Earlier this year, EDCTP published a Model for the certificate on the financial statements to support grantees in their reporting. DSW & PATH | EU-Africa and epidemic preparedness | 21/05 2021DSW, together with PATH, published a new policy paper ‘EU-Africa cooperation on epidemic preparedness and health security: success stories and lessons learned from COVID-19‘, reaching out to the European and African decision-makers participating in the Global Health Summit in Rome on 21 May 2021. EU Health Emergency Preparedness and Response Authority | How should the EU prepare and respond to future cross border health threats? | 21/05 2021In 2020, the European Commission announced the EU Health Emergency and Preparedness Response Authority (HERA) as part of a broader set of proposals for an EU Health Union. This report sets out the role that HERA could fill in the evolving European Health landscape. It is informed by interviews with over 40 experts from research organisations, civil society, think tanks and industry, based in Brussels, EU Member States and beyond.  Although consultation was a crucial element of the project, the report recommendations are independent and reflect the opinions of the Wellcome Trust and the Federation of European Academies of Medicine.  TDR | Global Health Matters Podcast | Episode 2: Women in Science | 26/05/2021TDR launched a podcast series on global health matters. Join Dr Garry Aslanyan and his expert panel of guests as they share their inspiring journeys as women leaders in global health. They also discuss the root causes of gender inequality in science and some strategies they have developed to address them. UKCDR & ESSENCE | New resource hub on equity in research partnershipsThe United Kingdom Collaborative on Development Research (UKCDR) and ESSENCE on Health Research (ESSENCE) launched a new resource hub to support equity in research partnerships. This hub brings together guidance, tools and principles on equitable partnerships from across the world, including the TRUST consortium and COHRED. To view the tools please visit: Equitable Partnerships Resource HubTAG | TAG 2020 Tuberculosis Treatment Pipeline ReportThe Treatment Action Group (TAG) 2020 Tuberculosis Treatment Pipeline report offers summaries of influential treatment studies and data sets, and updates on new drugs and regimens in clinical development for TB. Among other studies, the report features the EDCTP-funded Simplici-TB and PanACEA consortia. BCG World Atlas | New update – Third edition | Published March 2021The BCG World Atlas provides an interactive map with detailed information on current and past BCG vaccination policies and practices for over 200 countries. Global Coronavirus COVID-19 Clinical Trial TrackerThe trial tracker is an interactive map offering an overview of COVID-19 clinical trials globally. Check out the About and Partners sections: “The COVID-19 Clinical Trial Tracker is headed by Kristian Thorlund, Edward Mills, and Cyrus Mehta with the goal of consolidating COVID-19 trial information. They aim to make vital information easily and widely available to the public, as well as further scientific efforts by helping fellow researchers work efficiently and plan trials.” Final report | New study on research partnerships in global health | Published March 2021The final report from a study commissioned by the the UK’s Foreign, Commonwealth & Development Office (FCDO) entitled “Accelerating global health R&D: the role of product development partnerships” was published in March 2021. The study assessed development of new medicines and technologies for 35 poverty-related and neglected diseases, including HIV/AIDS, malaria and tuberculosis. The role of EDCTP in accelerating global health R&D, and in partnership with product development partnerships, is well highlighted.
Funding opportunities
Africa Oxford initiative | AfOx Travel Grants, 2019+ | Ongoing callAfOx Travel Grants support the establishment of new collaborations between researchers in African countries and their collaborators at the University of Oxford. Travel Grants are open to all disciplines and open all year round. So far 100 travel grants have been rewarded to researchers from the African continent and the University of Oxford.More information SARETI | Research ethics training | Deadline 30/07 2021The South African Research Ethics Training Initiative (SARETI) at the University of KwaZulu-Natal has been awarded competitive funding from the Fogarty International Center (FIC) of the US National Institutes of Health (NIH), to offer doctoral training in research ethics through the SARETI Leadership Programme, beginning 2021. The main goal is to train high-level African research ethicists who will produce local and internationally relevant scholarship and leadership in research ethics in Africa.More information PRIZE Hideyo Noguchi Africa Prize | Infectious diseases – Africa | Deadline 20/08 2021“The prize carries the ideals and aspirations of a Japanese microbiologist Dr Hideyo NOGUCHI (1876-1928) who fell victim to yellow fever in Africa during his research of the disease. It aims to honour individuals with outstanding achievements in the fields of medical research and medical services to combat infectious and other diseases in Africa, thus contributing to the health and welfare of the Africans and of all humankind. As the challenges caused by Covid-19 is testing for humanity and it reaffirms the special importance of the Noguchi Hideyo Africa Prize. We look forward to receiving your nominations.” More information
Upcoming events
UKCDR | Webinar: Equitable Partnerships for global research 10/06/2021UKCDR will be co-hosting a webinar on 10 June 2021 on Equitable Partnerships, in partnership with the Association of Commonwealth Universities (ACU) and the Research Fairness Initiative: Equitable partnerships for global research webinar. The event includes speakers from a range of locations, and UKCDR’s Executive Director, Marta Tufet, will be presenting on the importance of equitable research partnerships, as well as highlighting the recently launched resource hub and equitable partnerships project.
IAS | 11th Conference on HIV Science | 18-21/07 2021The International AIDS Society organises its biennial scientific conference on 18-21 July 2021. The conference presents the basic, clinical and operational research that moves science into policy and practice. From the website: “Through its open and inclusive programme development, the meeting sets the gold standard of HIV research featuring highly diverse and cutting-edge studies. IAS 2021 participants can expect a full conference experience via an easy-to-use digital platform that connects researchers, health care providers, advocates and policymakers. Additionally, a local partner hub will convene locally-based experts in the original host city of Berlin, in accordance with local health advice and regulations.” ·     Sign up for updates·     Registration now openEDCTP | Tenth Forum | 17-21/10/2021The Tenth EDCTP Forum will be held as a virtual meeting hosted from the Joaquin Chissano International Conference Centre in Maputo from 17 – 20 October 2021. The Forum theme – Equity in research for health – is at the core of the EDCTP mission. EDCTP welcomes your engagement and your input in discussions at the Forum about successes and challenges in achieving equity in research, and how best to ensure that research processes and outputs address health inequities. The call for abstracts (oral and poster presentations) is open. Deadline: 10 June 2021. Our host partners, the Ministry of Health of Mozambique, through the National Institute of Health, and the Manhiça Health Research Centre promise an exciting and interactive meeting experience. We look forward to your participation. More information on the 10th EDCTP Forum website, including sponsorship packages.2nd LEAP Scientific Conference | Call for Abstracts | 2-4/11 2021
Drugs for Neglected Diseases initative(DNDi) and the Leishmaniasis East African Platform (LEAP) invites individuals and institutions from the African continent and other parts of the world to submit abstracts to the 2nd LEAP Scientific Conference. Abstracts submission deadline is: 30/06/2021 11:30 EAT via leap@dndi.org