MVVC sponsored students

Muhammed Afolabi (PhD student)

Funded by the EVI supported Malaria Vectored Vaccines Consortium (MVVC) sponsorship programme.

Based at: London School of Hygiene and Tropical Medicine, UK, and the Medical Research Council Unit, The Gambia
First Supervisor: Prof Daniel Chandramohan, London School of Hygiene and Tropical Medicine (LSHTM)
Second Supervisor: Dr Kalifa Bojang, Medical Research Council (MRC), The Gambia

Evaluation of alternative informed consent procedures in clinical trials conducted in The Gambia

Obtaining a valid informed consent is globally recommended before a biomedical research is conducted.  An important component of a valid informed consent requires a potential research participant to understand information disclosed before he or she voluntarily gives consent to participate in the study.  However, evidence exists that current informed consent procedures and practices cannot engender understanding of informed consent among research participants in many developing countries of Africa where there are low literacy levels and other poor socio-economic conditions.  Due to these challenges, a growing number of innovations aimed at improving informed consent understanding have been suggested but relatively few of these initiatives have been evaluated to determine their effectiveness in aiding understanding of informed consent among research participants in these developing countries.

This study therefore aims to evaluate an alternative informed consent procedure with a view to providing insights into how best to improve understanding of clinical trial participants on informed consent in The Gambia.  The study will specifically validate a standardised informed consent comprehension test for use in The Gambia and employ this validated instrument to compare understanding of participants in clinical trials taking place in two clinical trial sites in The Gambia.  The participants will be randomised at a ratio of 1:1 to either an intervention group in which informed consent is delivered in audio-visual format through a locally customised battery operated ‘Speaking Book’; or the written informed consent (control group).  Understanding about key themes of informed consent including voluntary participation, rights of refusal, placebo, randomisation, blinding, compensation will be assessed in both groups at baseline, 1 month, 2 months and 3months after consent is given.  At 3 months, participants in the intervention group will be re-randomised to either the audio-visual intervention or written informed consent and their sustained understanding will be evaluated 3 months later.  To explore factors that may influence the decision not to participate in the trials; structured interviews will be held for potential participants who do not give consent to enrol in the trials.  The cost of the two informed consent procedures will also be estimated to assess sustainability and reproducibility of the alternative informed consent procedure in future clinical trials.

This research will provide unique information about validation of a standardised informed consent comprehension test and evaluation of an alternative informed consent tool that may be adapted for use in clinical trial settings in developing countries.

Muhammed obtained a medical degree from the University of Ibadan, Nigeria and a master degree in Public Health from Obafemi Awolowo University, Ile-Ife, Nigeria.  He also holds the postgraduate fellowship of the West African College of Physicians and National Postgraduate Medical College in Family Medicine.  Muhammed joined the service of the Medical Research Council, The Gambia, in June 2009 as a Research Clinician and coordinated the clinical and field aspects of an EDCTP-funded infant HIV-1 vaccine trial, whereafter he joined MVVC as the clinician coordinating the clinical and field aspects of malaria vectored vaccines clinical trials in adults, children and infants.  Through the capacity building activities of MVVC, he also obtained a diploma in Clinical Research from the Vienna School of Clinical Research, Austria.

Ya Jankey Jagne (MSc student)

Funded by the EVI supported Malaria Vectored Vaccines Consortium (MVVC) sponsorship programme.

Based at: Medical Research Council, The Gambia

MSc Immunology of Infectious Diseases

At the end of the course work, Jankey will have knowledge and understanding of the basic principles of host immunity to infection against the diverse range of pathogens which confront human populations and will be able to apply this specialised knowledge to a range of practical skills and techniques.  In particular, she will learn about modern molecular and cellular techniques for assessing immune responses to pathogens and will be able to critically assess, select and apply appropriate research methods to investigate basic immunological mechanisms and applied issues in the immunology of infection.  She will also be able to critically evaluate primary scientific data and the published scientific literature, and integrate and present key immunological concepts at an advanced level, both verbally and in written form.

Ya Jankey Jagne studied Biological Sciences at the University of the Gambia and has worked at Medical Research Council (MRC), for four years as a Scientific Officer on several different studies, including the malaria vaccine clinical trial to assess safety and immunogenicity of the prime boost vaccination strategy using AdCh63 ME-TRAP and MVA METRAP in healthy Gambian adults and children.

David Tiga Kangoye (PhD student)

Funded by the EVI supported Malaria Vectored Vaccines Consortium (MVVC) sponsorship programme.

Based at: Centre National de Recherche et de Formation sur le Paludisme (CNRFP), Burkina Faso
First Supervisor: Dr Philip Bejon, Kenya Medical Research Institute (KEMRI)
Second Supervisor: Dr Issa Nebie Ouedraogo, CNRFP

Transplacentally acquired antimalaria antibodies and protection against Plasmodium falciparum malaria during the first two years of life.

Children under five are more susceptible to malaria and its complications than older children and adults as evidenced by the 2010 WHO estimates of 85% of deaths attributable to malaria in this age group.  In 2000, Rowe et al. estimated the number of child deaths caused by malaria in Africa to be 804,000.  It was previously thought that newborn infants living in endemic areas are temporarily markedly resistant to P. falciparum malaria (Lars Hviid, 2004).  This was evidenced by low parasitemia and predominance of asymptomatic malaria in infants during their first few months of life (Wagner et al., 1998).  Maternally-derived antibodies are commonly believed to explain this natural protection in infants (Le Hesran et al., 1999). But a number of studies did not find significant protective effect of these maternally-derived antibodies.  The question is then, does transplacentally acquired anti-malaria antibodies really protect against malaria?

To answer this question, 140 infants have been enrolled, between 4 and 6 week of age, in a prospective cohort study and we are continuing follow up during the first two years of life by both active and passive case detection, to assess malaria incidence.  To assess the levels of anti-malaria antibodies, capillary blood samples have been collected on a monthly basis during the first 6 months of follow up, and thereafter samples will be collected every three months until the end of the study period.  The study area is located at Banfora, 441 km South-West of Ouagadougou, capital city of Burkina Faso.  The climate is of Soudano-Guinean type with an annual rainfall above 900mm.  The malaria transmission at Banfora is perennial and markedly seasonal with a peak during the rainy season from June to October.

In 2007 David obtained a medical degree from the Université Cheikh Anta Diop, Dakar (UCAD) and wrote his doctoral dissertation on the topic “Medical Informatics and its applications in Senegal: State of the Art” under the supervision of Prof. Anta Tall Dia and Dr. Issa Wone.  Furthermore, he worked as a General Practitioner at the Matam District Hospital in North-East Senegal from 2006-2007, and since 2008 is a sub-investigator in clinical trials and epidemiological studies at CNRFP, Burkina Faso.

Mahamadou Mansour Ndiath (PhD student)

Funded by the EVI supported Malaria Vectored Vaccines Consortium (MVVC) sponsorship programme.

Based at: University Cheikh Anta Diop de Dakar (UCAD), Senegal
First Supervisor: Dr Badara Cisse, UCAD
Additional Supervisors: Dr Philip Bejon, Kenya Medical Research Institute (KEMRI), Pr Oumar Gaye, UCAD, Dr Cheikh Mbacke, UCAD

Evolution of malaria morbidity from 2008 to 2011: Identification and characterisation of malaria hot spots in Keur Soce health and demographic surveillance site system

Malaria is a major public health problem and it is estimated that 40% of the world population lives in areas at risk of infection.  The disease causes approximately 500 million clinical cases and 1 million deaths each year.  About 90% of these deaths occur in sub-Saharan Africa.  In the Sudano-Sahelian zone, malaria affects mainly the life of children under five and pregnant women.  However, recent data indicates that as the incidence of malaria decrease, it is becoming more common in older children.

In Senegal, malaria is endemic with a seasonal increase in transmission during the rainy season.  Over the recent years in Senegal, much has been achieved in regard to malaria control strategies.  Malaria morbidity and mortality have significantly been reduced, certainly due to the implementation of effective interventions.  However, these measures have led to a change in the epidemiological profile of the disease with a reduction of transmission.  Identifying and characterising the foci of transmission as well as detecting potential new risk factors should form the cornerstone of both successful malaria control and malaria elimination in stable and unstable malaria transmission area.  However, a better understanding of the epidemiology of malaria is necessary to maximise the impact of the interventions.

Thus the identification and characterisation of foci of transmission will redirect malaria control efforts to specific geographic areas, reduce cost and increase the effectiveness of interventions.  Mastering transmission areas such as hotspot could probably lead to an eventual elimination of malaria in areas of low transmission or stable transmission.

Retrospective data from the National Malaria Control Program are being used to evaluate foci of residual transmission at the national level.  To support these analyses, we are using SaTscan software to identify hot spots using Rapid Diagnostic Test (RDT) confirmed malaria cases in all the country over the period from 2008 to 2010 and to detect the foci of residual malaria. Stata 11 will be used to plot the hotspots and investigate their level of significance.  Geographic Information System maps will also be made to localize the area of persistent malaria.  Finally, this study will help to have a better understanding of the epidemiology of malaria in the Sahel region.

In 2006, Mansour obtained a Master of Arts (MA) in Geography of Health from University Cheikh Anta Diop (UCAD) in Dakar, Senegal.  In 2008, he was awarded a scholarship by the Indepth Network under the Special Program for Scientific Development and Leadership to study for a Master's degree in Epidemiology and Biostatistics at the University of Witwatersrand in Johannesburg, South Africa.  After being awarded an MSc Med in Public Health, Mansour joined the Department of Parasitology at UCAD in December 2010 as Demographer–Statistician.

In 2011, Mansour was awarded a PhD scholarship by MVVC.  In parallel to his PhD studies, he is the coordinator of a study that will be implemented by Glaxo Smith Kline starting in December 2012 on cohort event monitoring in order to define incidence rates of disease specified as adverse event of specific interest (AESI).

Francis Maina Ndung'u (Postdoc.)

Funded by the EVI supported Malaria Vectored Vaccines Consortium (MVVC) sponsorship programme.

Based at: Kenya Medical Research Institute, Kenya (KEMRI)
Supervisors: Dr Philip Bejon, KEMRI and Professor Kevin Marsh, KEMRI

Research project: B and T cell memory and immunity to malaria

Francis’ research concentrates on understanding the cellular and molecular basis of naturally acquired immunity to malaria, in particular in the generation and maintenance of antigen-specific memory B and T cells.  He is also investigating the cellular and molecular mechanisms that regulate the immune response to Plasmodium falciparum, thus achieving a balance between immune-mediated parasite clearance and immunopathology.  Of late, he has begun investigating the cellular and molecular basis for the recently reported interaction between malaria and non-typhoid salmonella.  Unraveling these mechanisms would help to boost the development of malaria vaccines.

In summary, his current projects include the investigation of (i) the induction and maintenance of B cell memory and antibody production, (ii) the induction and maintenance of T cell memory to malaria, (iii) antibody function in malaria, (iv) mechanisms of immune regulation during malaria infection, especially the balance between pro-inflammatory and anti-inflammatory mechanisms, and (v) the effect of malaria infection on immunity to non-typhoid salmonella.

Dr Francis Ndung’u started his scientific career as a research assistant at KEMRI in 1998 and obtained a Bachelor of Education (Science) and Master of Science (Medical Parasitology) from Kenyatta University, Nairobi, Kenya, followed by a PhD in 2004 in Cellular Immunology at the National Institute for Medical Research, London, UK.  Until 2008, he held an initial postdoctoral training position in the same laboratory.   Dr Ndung’u has completed his postdoctoral research at KEMRI, Kenya.  He recently won an independent research grant from the MRC to continue his research at KEMRI.

Massamba Syll (MSc student)

Funded by the EVI supported Malaria Vectored Vaccines Consortium (MVVC) sponsorship programme.

Based at: University Cheikh Anta Diop de Dakar (UCAD), Senegal
First supervisor: Pr Yerim Mbagnick Diop, UCAD
Second supervisor: Dr Badara Cisse, UCAD

Optimisation of operational research processes in Keur Soce health and demographic surveillance site.

Research, which costs are increasing rapidly due to the continuing development of innovative and highly specialised technologies, faces a funding problem and must prove its usefulness to the funding organisations.

Research institutes therefore increasingly need to compete.  The need to generate data in the best possible conditions of cost, time and customer satisfaction, and finally the need to be assured of the quality of the products and services of their suppliers led research institutions to adapt and implement the concepts of Quality and Quality Assurance, first at the stage of the design of Clinical Trial Protocols, conduct of clinical trials and in different stages of the process to the publication of results.

By entering this global requirement for Quality Assurance the research and training center of Keur Soce wants to initiate the quality process in its research activities.

In January 2014 Massamba successfully completed two MSc degrees in “Biologie et Contrôle des Parasites” and “Analyses Physicochimiques et Management de la Qualité en Santé”   His thesis title is “Quality assessment of Keur Socé’s Research and Training Centre laboratory in compliance with ISO 15 189”, which will allow the implementation of an initial quality assessment of the site., followed by recommendations for the effective implementation of additional quality measures.

Dr Massamba Syll is a Research Assistant Pharmacist and has been a member of the research team in the Parasitology and Mycology Department at UCAD since November 2010.  He received his doctoral degree in pharmacy with a focus in biology from the Faculty of Medicine of UCAD in 2010.  Massamba is also the pharmacist responsible for drugs and investigative products at the research and training center of Keur Soce, Senegal.  Additionally, he is involved in the process of validating the results of laboratory tests.  As a Master’s student in Quality Management, Massamba is responsible for the implementation process of the quality measures in the centre.

Jean Baptiste Bibié Yaro (MSc student)

Funded by the EVI supported Malaria Vectored Vaccines Consortium (MVVC) sponsorship programme.

Based at: Centre National de Recherche et de Formation sur le Paludisme (CNRFP), Burkina Faso
Supervisor: Dr. Sodiomon B. Sirima, CNRFP

Seasonal variation of malaria infection in a stable malaria transmission area in Burkina Faso.

The Banfora Health District in Burkina Faso is preparing for implementation of malaria vaccine trials by CNRFP.  Because malaria infections in this area were not investigated sufficiently and the malaria infection rate is used as the outcome to assess the efficacy of malaria vaccines, the main objective of this project is to measure the seasonal prevalence of malaria infections in children under five years of age (potential volunteers of malaria vaccine trials), who are living in a stable and seasonal malaria transmission area in Banfora Health District.

Jean Baptiste Yaro holds a medical degree, a Monitor and CRA diploma, and a Health Outcomes Research diploma.  He has worked as a scientist in clinical research and as Project Manager.  Currently, he works at CNRFP where he is a clinical investigator and coordinates clinical trials.  His main interests lie in malaria drug and vaccine research.  Jean-Baptiste also studied clinical research at the Vienna School of Clinical Research in Austria and graduated with a Master’s degree in Clinical Research in 2012.