Summary

Young infants are more susceptible to infection than individuals at any other life stage. Their immune systems are inexperienced and they are too young to benefit from infant vaccination, most of which are given several weeks after birth. In the first weeks of life, babies rely on protective proteins called antibodies, which are transferred across the placenta from the mother to the baby whilst still in the womb. In some cases, the amount of antibody transferred to the baby is not sufficient to protect the baby from infections, such as whooping cough. Vaccines given in pregnancy aim to increase the amount of antibody in the mother’s blood, so that more antibody is transferred across the placenta to the baby so that the infant is protected until they are old enough to receive infant vaccines.

Antibody is transferred across the placenta by binding to specialised receptors on the surface of placental cells. In this project, we aim to study each part of the antibody-receptor interaction, namely:

• Functional changes in the antibody
• The amount and location of the antibody receptor
• The strength of the binding between the antibody and the receptor

We aim to understand how these factors change throughout pregnancy, by testing stored blood and placental samples. We will also look at how vaccination in pregnancy can affect these factors.

In developing countries, a significant proportion of pregnant women are affected by HIV infection. This can affect how well antibody is transferred across the placenta. We aim to understand how HIV affects the maternal antibody and how well it binds to the receptor in the placenta.

We hope that this project will help us understand more about the way babies are protected by vaccines in pregnancy and in the future, help us design vaccines that are more effective at protecting the mother and infant.

Project lead

Dr Chrissie Jones
Associate Professor and Honorary Consultant in Paediatric Infectious Diseases Clinical and Experimental Sciences
Room LF102, F Level
South Academic Block University Hospital Southampton NHS Foundation
Trust Tremona Road
Southampton SO16 6YD
United Kingdom

IMPRINT partner

Beth Holder, London School of Hygiene and Tropical Medicine, London, UK

Project duration

12 months

Summary

Pregnant women sometimes carry a bacterium called Group B Streptococcus (GBS) in their vagina or rectum. During pregnancy or upon delivery, GBS may be transmitted to the baby resulting in the death of the baby in the womb or go on to cause infections such as sepsis or meningitis soon after birth. GBS disease is more serious in some low- and middle-income countries (LMICs) where pregnant women do not have access to proper antenatal care and antibiotics. A solution would be to vaccinate mothers against GBS, so they can produce antibodies protective proteins (antibodies) that can be transferred to the baby through the placenta and protect them from developing an infection in the first place. Interestingly, LMICs situated in South-East Asia report a low GBS disease burden while high GBS disease rates are documented on the African continent, in countries such as Malawi or South Africa.

In this project we aim to collect the blood of GBS-colonised mothers from high vs. low GBS disease burden countries (U.K. vs. Malawi vs. Bangladesh) and compare how the immune system of the women reacts to GBS by measuring anti-GBS antibody concentrations, the ability of the antibody to kill the bacteria, as well its ability to bind to factors present on the surface of the GBS bacteria. We also aim to examine how effectively the antibodies are transferred across the placenta and give protection to babies.

By comparing the properties of antibodies collected from high- vs low- disease burden countries, we hope to understand the criteria that are essential for the optimal transfer of GBS protective antibodies from mother to baby. Altogether this knowledge will significantly help towards the design of more efficient and safe vaccines to protect new born babies from life-threatening GBS disease.

Project lead

Dr. Shadia Khandaker
Department of Clinical Infection, Microbiology and Immunology
Institute of Infection and Global Health
University of Liverpool
United Kingdom

IMPRINT partner

Prof. Aras Kadioglu, University of Liverpool, United Kingdom
Prof. Neil French, University of Liverpool, United Kingdom
Prof. Samir Kumar Saha, Child Health Research Foundation (CHRF) Bangladesh Institute of Child Health Research Foundation, Dhaka Shishu (Child) Hospital, Bangladesh

Project duration

24 months

Shadia Khandaker

Shadia is a Clinical Microbiologist who possess an intrinsic aspiration for research in paediatric infectious disease and its prophylactic management. She is currently finishing her PhD thesis as a Commonwealth Scholar in the Institute of Infection and Global Health at the University of Liverpool. She holds a M. Phil in Microbiology as well as a Bachelor in Medicine and Surgery.

From 2012 on she has been serving as an Assistant Professor at the Department of Microbiology, Ibrahim Medical College, Bangladesh and will return to her position after completing her postdoctoral research. Her career history entails a variety of positions including academic, laboratory consultant, teacher and researcher in the field of medical microbiology.

Summary

During pregnancy, the placenta is the interface between mother and baby. Its’ specialised structure allows nutrients and protective molecules such as antibodies to be transferred to the developing baby. These antibodies help project the infant in the first weeks of life, when the infant is exposed to viruses and bacteria for the first time. In several countries, we now vaccinate women against certain diseases, which increases the amounts of specific antibodies passed to the baby, therefore protecting them against disease.

Surprisingly, despite the importance of trans-placental antibody transfer, there is lots we still do not know about this process. This includes how the antibody crosses all the different cell layers between the mother’s and baby’s bloodstream, how changes in the mother’s immune system may affect antibody transport, and how differences in the structure of antibodies can increase or decrease their transport to the baby. Understanding these issues will help us to optimize maternal vaccination programmes to protect infants in early life.

One way to address some of these gaps in our knowledge is through use of placental perfusion. This technique uses a piece of the human placenta donated after birth, which is kept in a warm chamber and bathed in fluids to copy how it functions during pregnancy. We can therefore track the movement of different types of antibodies across the human placenta in the laboratory, without the need for animal models. This will help us understand what regulates how well certain antibodies are passed to the baby. Our project brings together a placental biologist and an expert in antibody function, in order to answer pressing questions around how infants are protected from early-life infections, and how we can develop new vaccines in order to improve this.

Project lead

Dr Beth Holder
Research Associate
Department of Pediatrics
London School of Hygiene and Tropical Medicine
United Kingdom

IMPRINT partner

Dr Margaret Ackerman, Thayer School of Engineering, Dartmouth College, USA
Dr Paul Brownbill, Division of Developmental Biology & Medicine, The University of Manchester, United Kingdom

Project duration

12 months

Summary

Babies have more protection against some diseases (e.g. whooping cough, tetanus) in the first few months of life if their mothers are vaccinated during pregnancy. Vaccines given to mothers produce antibodies that fight disease. These ‘maternal’ antibodies are passed on to babies before birth and protect them whilst they are too young to be vaccinated themselves.

Naturally, over time, maternal antibodies in babies decline. It is therefore important that, at some point, babies receive their own vaccinations to keep them protected. Timing is important. If maternal antibodies still exist in babies when they receive their first vaccinations, they may have a lower antibody response. This may mean that they are not protected as well as they could be.

In planning vaccine programmes, therefore, it is important to understand how quickly maternal antibodies decline in babies.

Currently, there is little information about the rate at which maternal antibodies decline in babies for some common vaccines. Antibody levels may decline at different rates for different vaccines. Until we know more, it is difficult to find out the best time to vaccinate babies.

We can find out more by using information from studies that have already finished. We will collect data from studies that have looked at antibody levels in two blood samples in babies. We will work out the rate at which maternal antibody levels decline in them. Combining data in this way means that we will have enough data for accurate calculations without taking any further blood samples.

Our project will provide information that will help improve the planning of vaccine programmes in order to provide the best protection for babies against disease.

Project lead

Dr Merryn Voysey
Senior Statistician
Nuffield Dept Primary Care Health Sciences, University of Oxford
United Kingdom

IMPRINT partner

Dr Elke Leuridan, University of Antwerp, The Netherlands
Dr Flor Munoz-Rivas, Baylor College of Medicine, USA
Dr Ha Thi Thu Hoang, National Institute of Hygiene and Epidemiology, Vietnam
Dr Nasamon Wanlapakorn, Department of Pediatrics, Chulalongkorn University, Thailand
Prof. Andrew Pollard, Department of Paediatrics, University of Oxford, United Kingdom

Project duration

12 months

Summary

Whooping cough can cause serious disease, particularly in young infants. In the UK, and other countries around the world, it is recommended that pregnant women receive the whooping cough vaccine in order to protect mothers and infants against whooping cough. Antibodies (protective proteins) are transferred across the placenta from the mother to the infant and protect the infant in the first months of life, before the infant is protected by infant whooping cough vaccination. There are concerns that high levels of maternal antibody in the infant at birth may prevent the infant from producing such a good response to their own vaccines.

There is a type of blood cell in the circulation called “T Follicular Helper” cells (or TFH cells for short.) These cells are thought to be important for how well the body produces the protective antibody proteins in response to vaccination. It is important to understand if vaccination in pregnancy can affect how well these specialised cells develop in the infant’s blood stream and therefore how well the infant responds to their own vaccines. Other specialised cells that are important to how well the infant responds to infections like whooping cough, such as “T” cells, may also potentially be affected by vaccination in pregnancy.

In this study, we will work with partners in Thailand who are already carrying out studies looking at whooping cough vaccination in pregnancy. We will work with samples that have already been collected, from infants born to vaccinated mothers and infants born to unvaccinated mothers. This will allow us to compare the infant’s cellular response to vaccination in these different groups of infants.

We hope that this study will improve our understanding of infant immunity and inform future vaccination strategies.

Project lead

Dr Qibo Zhang
Senior Lecturer in Immunology
Institute of Infection and Global Health
University of Liverpool
Southampton, United Kingdom

IMPRINT partners

Dr Elke Leuridan, University of Antwerp, Belgium
Prof. Yong Poovorawan, Chulalongkorn University, Thailand

Project duration

12 months

Summary

The ultimate aim of our work is to develop vaccines that will be taken by pregnant women and which will then protect babies from catching infections caused by, for example, HIV, hepatitis B and Zika, during birth. The vaccines will be taken by mouth, but will have their effects in the mother’s vagina. The oral route of vaccine taking has been chosen as this route is expected to have higher acceptability and be cheaper than injections, which have to be sterile, need to be given by medically-trained personnel and can be painful. The cost factor is especially relevant in LMIC, for poorer people and where healthcare costs are largely borne by individuals, rather than the state.

For oral vaccines to have an influence in the vagina, they have to be prepared using specific chemicals, such that once a vaccine is swallowed, it is only processed in the large bowel (and nowhere else in the gut). In this project, we will: i) identify those chemicals, ii) prepare the vaccines, and iii) test whether the prepared vaccines will be processed in the large bowel following swallowing.

The results of this study will be used to apply for follow-on funding to determine whether such vaccines will have an influence in the mother’s vagina and protect newborns during birth.

Project lead

Dr Sudaxshina Murdan
Reader in Pharmaceutics
UCL School of Pharmacy
University College London
London, United Kingdom

IMPRINT partners

Prof. Abdul Basit, University College London, United Kingdom
Dr Fatme Mawas, National Institute for Biological Standards and Control, MHRA, United Kingdom

Project duration

8 months

Summary

Whether vaccines given to women in pregnancy (maternal immunization) have an effect on the developing immune system of the newborn baby are still not well understood. However, this knowledge is important to make sure that current and future vaccines used in pregnancy can be used in the most efficient and protective way. Whilst we have better insights into the effect of the maternal vaccines on the antigen-specific, acquired immune responses in the newborn, but there remains a gap in knowledge about effects of maternal vaccination on infant natural defense cells (innate immunity) and any potential modification of these cells.

This project will use cord blood samples collected within an ongoing large-scale observational study of neonatal vaccine responses to develop a prototype of assays in the lab that will allow us to investigate the effects of maternal antibody on the natural defense cells in the newborn. Initially we will use the model of tetanus vaccination, given that this vaccine is already routinely given to pregnant women in The Gambia. This model can then serve to assess the potential impact of other maternal vaccines on neonatal innate responses, such as pertussis or future vaccines. In addition, we will examine in another lab assay whether "training" of specific cells generated from cord blood (monocytes) by BCG -another vaccine used in the newborn- can induce changes in gene expression. We will also have the opportunity to measure if the early natural cellular responses have an influence on the antibody levels measured in response to vaccines the baby receives in the first few months of life.

This knowledge will help us to estimate if there is potential for clinical impact on longer term antigen-specific immunity in the infants or not.

The fellowship is embedded in an existing strong research partnership between the three research sponsors in Gambia, Vancouver and Brussels and will provide the fellow with the opportunity to develop an independent complimentary aspect of the research around one of the key challenges identified by the IMPRINT network.

Project lead

Dr Alansana Darboe
Vaccine & Immunity Theme
Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine

IMPRINT partners

Prof. Beate Kampmann, London School of Hygiene and Tropical Medicine, United Kingdom
Prof. Tobias Kollmann, University of British Columbia, Canada
Prof. Arnaud Marchant, Université Libre de Bruxelles, Belgium

Project duration

24 months

Dr Alansana Darboe

Alansana received his BSc. (Hons) Biomedical Science in 2010 from the University of Manchester and his Doctorate of Philosophy in 2017 from the University of London, at the London School of Hygiene & Tropical Medicine. His career at the MRC Unit the Gambia at the London School of Hygiene & Tropical Medicine started in 2003 where he, among other positions held, served as High Scientific Officer from 2012-2016. Since 2017 he holds a postdoc position at MRC with a strong focus on Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity and breakthrough infections of hepatitis B virus after vaccination. His IMPRINT funded 2 years fellowship project will tie up with his existing projects and scientific knowledge.

Summary

Infections and nutritional deficiencies, including iron deficiency, affect millions of young children in Low- and Middle-Income Countries (LMICs). Moreover, iron deficiency has recently been reported as the most common cause of preventable death and disability in such settings. Recent evidence indicates that iron is essential for effective immune responses, so iron deficiency could therefore contribute to impaired immunity leading to poor responses to vaccines and infection susceptibility in infants. However, the ways in which iron deficiency, and treating infants with iron supplements, influence infant immunity in LMIC settings remains poorly explored.

This proposal will address this issue by applying a state-of-the-art immunological method termed CyTOF to blood samples obtained from infants participating in a large clinical trial of iron supplementation in Bangladesh; this trial is investigating the relative pros and cons of iron treatments for infants. CyTOF will enable us to study how iron affects the array of different types of white blood cells in circulation, and the functioning of these different immune cell types. We will link this information with data collected concurrently from the same infants including their immune responses to the measles-rubella vaccine, the diversity of microorganisms found in their intestine, as well as data on infection, growth and developmental.

Together, the study will advance understanding of how nutrition can shape development of the immune system in infants in settings were the ability to mount competent immune responses to immunisations and infections is of great importance. The data will also inform global health policy makers in developing guidelines regarding the use of iron treatments in infants in infection-susceptible populations.

Project lead

Dr Andrew Armitage
Senior Postdoctoral Scientist
MRC HIU, MRC WIMM
University of Oxford
United Kingdom

IMPRINT partners

Dr Sant-Rayn Pasricha, Population Health & Immunity Division, Walter and Eliza Hall Institute of Medical Research, Australia
Dr Jena Hamadani, Maternal and Child Health Division, icddr,b, Dhaka, Bangladesh
Dr Giorgio Napolitani, MRC HIU, MRC WIMM, University of Oxford, United Kingdom

Project duration

12 months

Summary

Globally each year more than 1 million infants die from infections, and most of these deaths occur in low-income countries. The time that children are at highest risk of serious infections is during the first few months after birth.

A large study conducted in India found that supplementing newborns during the first 10 days of life with probiotics, which are live, harmless bacteria, lowered the risk for sepsis, diarrhoea and lower respiratory tract infections. The beneficial effect of probiotics on preventing respiratory tract infections in particular was unexpected and intriguing, suggesting that the effect of probiotics goes beyond that of a healthy gut.

Infants in Papua New Guinea (PNG) have one of the highest risk in the world for severe respiratory infections caused by Streptococcus pneumoniae (pneumococcus), including pneumonia. Before the pneumococcus causes disease, it first colonises the infant's nose. In PNG, almost all infants have been colonized with pneumococci by the age of 1 month.

The aim of this project is to conduct a pilot study to test two probiotic supplementations for safety and possible effects on early pneumococcal colonization and pneumococcal vaccine responses in PNG infants. This pilot study will support the implementation of a subsequent large clinical trial that will aim to study in PNG infants the direct and indirect impacts (by improving vaccine responses) of probiotics on serious infections including severe pneumonia, blood poisoning and meningitis. If proven to be efficient, probiotics supplementation could be a simple, safe and affordable intervention to safe infants’ lives.

Project lead

Dr William Pomat
Acting Director
Papua New Guinea Institute of Medical Research
Papua New Guinea

IMPRINT partners

Dr Anita van den Biggelaar, Vaccine Trials Group, Telethon Kids Institute, Australia
Dr Tobias Strunk, Centre for Neonatal Research and Education University of Western Australia
Prof. Tobias Kollmann, Division of Infectious and Immunological Diseases, Department of Pediatrics, University of British Columbia, Canada
Prof. Peter Richmond, Division of Pediatrics, University of Western Australia (UWA)
Dr Andrew Greenhill, Federation University, Victoria, Australia

Project duration

12 months

Summary

Giving vaccines to pregnant women is a useful public health measure. It will help to reduce death and disease among pregnant women and newborn infants from infectious diseases. This will be most important in low- and middle-income countries (LMIC). New vaccines are being developed for use in pregnant women e.g. for Group B streptococcus, respiratory syncytial virus and cytomegalovirus. The safety of vaccines administered to pregnant women is most important for pregnant women, healthcare providers, researchers, regulators, ethics committees, vaccine developers and communities. There is a need for a global coordinated approach to determine the safety of vaccines used for pregnant women and for Maternal and Child Health (MCH) studies. The GAIA (Global Alignment of Immunization safety Assessment in pregnancy) project has developed 21 globally consistent tools (case definitions of key terms) to determine the safety of vaccines in pregnancy. These can also be used for MCH studies. Assessment of these tools in LMIC is required. This study will assess key case definitions and terms using data from clinical studies conducted in South Africa and The Gambia. The study will determine how possible it is to utilize the case definitions, the quality and accuracy of the data collected, the challenges and advantages of using the case definitions and collection of any possible edits to the case definitions that would make them easy to use in LMIC.

Project lead

Sonali Kochhar, MD
Medical Director,
Global Healthcare Consulting
Scientific Researcher,
Department of Public Health
Erasmus University Medical Center
Rotterdam, The Netherlands

IMPRINT partners

Clare Cutland, University of the Witwatersrand, South Africa
Ed Clarke, MRC Unit The Gambia, Banjul, The Gambia

Project duration

9 months

Summary

Vaccination during pregnancy, also known as maternal immunization, has the potential to prevent disease and death among mothers and their infants. Maternal immunization can have tremendous impact in low and middle-income countries (LMICs) where burden of disease is very high and access to adequate healthcare can be problematic. However, not everyone is willing to accept vaccines, especially during pregnancy, due to safety and other concerns. Available maternal vaccines are safe and effective in preventing disease. Not taking vaccines puts the women and their children at risk of what can often be severe disease and this poses a significant public health challenge that needs to be addressed.

Our research project aims to identify factors of practical value that may affect individual vaccine acceptance during pregnancy. We will consider individual concerns and priorities, and factors beyond individual decision-making. This would include the influence of healthcare provider recommendation, facilitators and barriers to healthcare provider recommendation and the influence of policies and policy-maker priorities on vaccine acceptance. We also seek to understand the influence of contextual social, cultural, historical, political, economic, religious and media-related factors on vaccine acceptance.

We think that it is important to take a broad approach. Focussing on individual factors alone without considering wider influences of provider-level, policy/programme-level and contextual factors on vaccine acceptance is akin to studying diet and nutrition as determined purely by individual choice without consideration of social, cultural or financial circumstances.

We will conduct this research in India using a number of methods, including in-depth interviews, focus groups discussions and document review. Research participants will include pregnant women and new mothers, public and private healthcare providers, and policy-makers and key stakeholders. As a study outcome we will develop a comprehensive framework that looks at the relationship between public, provider, policy, structural and contextual factors on individual vaccine acceptance in order to identify ways to maximise access to and acceptance of safe and effective maternal vaccines.

Project lead

Dr. Neisha Sundaram
Department of Infectious Disease Epidemiology
London School of Hygiene and Tropical Medicine
United Kingdom

IMPRINT partners

Prof. Heidi Larson, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, United Kingdom
Dr Clarence Tam, Saw Swee Hock School of Public Health (SSHSPH), National University of Singapore, Singapore
Dr G.V.S. Murthy, Indian Institute of Public Health, Hyderabad, India

Project duration

18 months

Dr Neisha Sundaram

Neisha (MSc, PhD; Swiss Tropical and Public Health Institute and University of Basel, Switzerland) holds a research fellowship awarded by the Swiss National Science Foundation at the London School of Hygiene and Tropical Medicine and a visiting position at the Saw Swee Hock School of Public Health, National University of Singapore. Her research interests lie in the prevention and control of infectious diseases, with a focus on vaccine confidence and acceptance. Her research focuses on human papillomavirus (HPV) vaccine implementation in Southeast Asia and global mapping of HPV vaccine confidence. Her research portfolio includes identifying individual and institutional determinants of influenza vaccination among healthcare workers in Singapore, evaluating tuberculosis control in Cambodia, pandemic influenza vaccine acceptance and influenza control in Western India, and sociocultural determinants of oral cholera vaccine acceptance in Kenya. She has a growing interest in behavioural economics and economic evaluation of vaccines and a special interest in the integration of qualitative and quantitative research methods.

Summary

Vaccines have prevented millions of child deaths; however, 45% of remaining under-5 deaths occur during the neonatal period, when infants are vulnerable to disease. Immunisation of pregnant women with tetanus toxoid to protect mother and newborn from tetanus has been widely implemented and accepted.

Maternal immunisation has the potential to reduce or prevent stillbirths and neonatal deaths from other diseases including influenza, pertussis, Group B streptococcus and Respiratory Syncytial virus. Pregnant women have not been included in clinical trials for most vaccines and medicines, due to concerns about potentially detrimental side effects on foetus/ infant and mother.

It is important to understand knowledge, perceptions and acceptance of maternal immunisation programs in different countries, especially low- middle income countries, where the vast majority of stillbirths, neonatal infections and deaths occur. Additionally, understanding of the suitability of and resources available at local health care facilities to implement large-scale maternal immunisation programs is important to enable smooth and effective roll-out of maternal immunisation programs.

South African sites have been involved in vaccine-preventable disease (VPD) surveillance programs and maternal immunisation trials, and the large burden of VPD in new-borns encourages rapid roll-out of MI programs.

In this study, we aim to first describe the perceptions about and acceptability of maternal immunisation amongst communities in urban (Soweto, Johannesburg, Gauteng) and rural (Somkhele, Mtubatuba, KwaZulu-Natal) communities in South Africa; second to understand the social and cultural factors which impact on the acceptability of maternal immunisation; and third to assess health care worker and facility preparedness for roll-out of MI programs. In order to fulfill these outcomes, we will conduct interviews and group discussions with community members, and an electronic survey of health care workers.

Project lead

Dr Clare Cutland
Director Deputy
Respiratory and Meningeal Pathogens Research Unit, Wits Health Consortium
University of the Witwatersrand
Johannesburg, South Africa

IMPRINT partners

Prof. Janet Seeley, Department of Global Health and Development, London School of Hygiene and Tropical Medicine, Social Science and Research Ethics and the University of KwaZulu-Natal, South Africa
Dr Nellie Myburgh, Respiratory and Meningeal Pathogens Research Unit, Wits Health Consortium, University of the Witwatersrand, South Africa
Dr Nothando Ngwenya, Africa Health Research Institute, South Africa

Project duration

12 months

Summary

Vaccination during pregnancy can protect the lives of mothers and infants. However, some women have concerns about vaccination or limited understanding of the benefits, or they may be discouraged by male partners or other relatives who oppose vaccination. Women may also be vaccinated without having full understanding of the purpose of vaccines, or because they feel under pressure from health workers. Understanding women’s views and experiences of maternal vaccination can help ensure that vaccine delivery and communication programmes support active, informed demand and high coverage.

This research will explore acceptability of maternal vaccination in Vietnam and Malawi. Both Vietnam and Malawi provide tetanus vaccination for pregnant women. Uptake is high in both settings, but there are gaps in coverage and we lack information on communities’ views and understanding of vaccination. We will investigate experiences and perceptions of vaccination among pregnant women and new mothers and explore views among other groups whose attitudes may influence mothers’ decisions and experiences (including male partners, older women and health workers). We will speak to people in both rural and urban areas, to compare different cultural, economic and health service contexts. We will combine interviews, focus groups, observation of vaccine services, social media monitoring and a small-scale survey, to generate rich data and understanding.

Better understanding of the acceptability of maternal vaccination can inform efforts to improve the quality and coverage of maternal vaccine delivery in Vietnam and Malawi. The project will also provide a basis for further research, generating initial data and refining methods to support larger studies on potential new maternal vaccines.

The project team combines institutes from Malawi, Vietnam and the UK, with additional collaborators from the US, creating new partnerships for future research. Our research will benefit from and contribute to wider maternal vaccination research programmes conducted by these partners.

Project lead

Dr Kate Gooding
Postdoctoral Researcher and Head of MLW Community & Science Group
Liverpool School of Tropical Medicine (LSTM) and Malawi Liverpool Wellcome Trust Clinical Research Programme (MLW)
United Kingdom and Malawi

IMPRINT partners

Dr Mary Chambers, Oxford University Clinical Research Unit, Vietnam
Dr Joanna Raven, Liverpool School of Tropical Medicine, United Kingdom
Prof. Heidi Larson, Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, United Kingdom

Project duration

12 months

Summary

The InVxSIM project will setup a vaccine safety monitoring system in rural Uganda within the Iganga Mayuge health and demographic surveillance system (HDSS). It will focus on maternal and neonatal vaccine acceptability and safety. This project will be implemented in a population of over 90,000 individuals of which 18% are women in reproductive age. The HDSS demographic updates data that we routinely collect will be linked to the health facility electronic health records system which captures antenatal care for the mother and vaccinations in mothers and children.

The InVxSIM project will first assess the ability to measure obstetric and neonatal outcomes as defined in the GAIA project. It will also monitor the safety of maternal immunization to ensure that potential concerns are addressed rapidly. Lastly, we will build a system for identification, follow-up and delivery of reminders to get immunized to pregnant women. We hope that the project will improve information on vaccine safety, uptake and coverage, and thereby facilitate to maintain and improve trust in the maternal and neonatal immunization programs by being able to provide requested information rapidly. This may ultimately reduce mortality and morbidity because of better prevention of vaccine preventable diseases and be an example for other LMIC that may have similar fragmented information systems.

Project lead

Dr Dan Kajungu
Centre Leader & Executive Director
Iganga Mayuge HDSS & Makerere University Centre for Health and Population Research
Uganda

IMPRINT partners

Dr Daniel Weibel, Erasmus Medical Centre, Den Haag, The Netherlands
Dr Miriam Sturkenboom, University Medical Center Utrecht, The Netherlands

Project duration

18 months

Dr Dan Kajungu

Dan is the Centre Leader at the Iganga Mayuge HDSS  and Executive Director of Makerere University Centre for Health and Population Research in Uganda.

He is a Biostatistician in public health with more than 15 years’ experience of coordinating and managing research projects, designing studies, analyzing and managing data from clinical trials, pharmacoepidemiological studies, large hospital and survey databases, national health information systems. He received his MSc Biostatistics (Epidemiology) from Hasselt University, Belgium, certificates in public health, project monitoring and evaluation and a PhD in Public Health from Université Catholique de Louvain (UCL), Belgium – the doctoral research title was Use of data mining methods for Pharmacovigilance in Africa setting. He has mentored students and researchers to conduct research that have contributed to influencing policy in low and middle income country (LMIC) settings. In the past, he co-facilitated the review of Uganda’s health system strategic and investment plan which has helped inform national health policy.

Summary

Tuberculosis (TB) is a disease caused by a germ that can affect the lungs and in severe cases, the blood and the brain. Almost one million children, mostly from the tropics, suffered from TB in the year 2015. A vaccine called BCG is used to prevent this disease. It is given to babies and is able to prevent severe forms of TB that involve the blood and the brain but does not provide adequate protection from the lung form which is the most common. New vaccines that are able to do a better job at preventing TB in babies are needed. VPM1002 is a vaccine that has been developed to work better than BCG. It has been tested in adults and babies and the results show that it is safe, however we need to know how well it is able to kill TB germs. This study aims to use a tool in the lab to show how well the new vaccine, VPM1002 works in babies from Uganda, an African country where TB is common.

Project lead

Mr Simon Gwapa Kimuda
Associate Scientist
Immunomodulation and Vaccines
Medical Research Council/UVRI Uganda Research Unit on AIDS
Entebbe, Uganda

IMPRINT partners

Prof. Alison Elliott, Medical Research Council/UVRI Uganda Research Unit on AIDS, Uganda
Prof. Gerhard Walzl, Stellenbosch University, South Africa
Dr Helen Fletcher, London School of Hygiene & Tropical Medicine, United Kingdom

Project duration

12 months