Learn more about the projects for each research theme at MRC Unit The Gambia.
VAC058 - A Phase I trial to assess the safety and immunogenicity of ChAd63 ME-TRAP - MVA ME-TRAP heterologous prime-boost vaccination co-administered with EPI vaccines in Gambian infants
In collaboration with the Malaria Vectored Vaccines Consortium 2 (MVVC2), the Jenner Institute in Oxford, UK and the Université Cheikh Anta Diop de Dakar (UCAD), Senegal
Despite a decline in transmission in some parts of Africa, malaria remains a major public health concern, making the development of an effective vaccine still of high priority. Heterologous prime-boost vectored vaccination, using Chimpanzee Adenovirus 63 (ChAd63) and Modified Vaccinia virus Ankara (MVA) encoding ME-TRAP (thrombospondin-related adhesion protein fused to a multiepitope string), induces a strong T cell response, playing a key role in protection. Previous trials in Gambian, Senegalese, Kenyan and Burkinabe adults and children have shown the vaccine to be safe and highly immunogenic, with substantial efficacy observed in adults. This trial aims to extend the assessment of safety and immunogenicity of this vaccination strategy to a sample of African infants and neonates, representing the target age group for malaria vaccination. As, if licensed, this vaccine will be given to infants who receive childhood immunizations, serology will be performed to confirm all infants achieved protective titres to routine Expanded Programme Immunization (EPI) vaccines.
A phase 3, randomized, double-blind study to evaluate the safety, tolerability, lot-to-lot consistency, immunogenicity, and non-interference with concomitant vaccinations
Contact: Dr Ed Clarke
Funding: PATH Vaccine Solutions
This phase 3 trial of a novel pneumococcal conjugated vaccine follows directly on the back of a phase 1/2 trial of the same vaccine we have recently successfully completed at the Unit. The trial is recruiting 2250 infants aims to generate the safety and immunogenicity data required to support future licensure and WHO pre-qualification of the vaccine so it can later be made available through GAVI/UNICEF and other supply routes.
GC6-2013: Biomarkers for TB consortium
Contacts: Dr Jayne Sutherland
Funding: Bill and Melinda Gates Foundation
This project aims to identify and validate signatures of risk of TB disease. Household contacts at 4 African sites household were followed for 2 years. Blood samples were collected at enrolment, and after 6 and 18 months of follow-up. Persons with lung TB were identified during follow up. Samples from the TB cases were analysed and from matched controls, to identify prospective correlates of risk of TB disease.
TBVAC2020
Contacts: Dr Jayne Sutherland
Funding: European and Developing Countries Clinical Trial Partnership
MRC at LSHTM is involved in the discovery of new TB biomarker candidates using innovative approaches. Using samples collected through the TB case-contact (TBCC) platform at MRC at LSHTM, we aim to define biosignatures of protection to Mtb infection using ‘omics analysis of samples from highly TB exposed but persistently TST negative (uninfected) subjects. Analysis of RNA, plasma (metabolites and antibodies) together with Flow cytometry will allow profiling of the ‘global space’ in TB.
Screen-TB
Contacts: Dr Jayne Sutherland
Funding: European and Developing Countries Clinical Trial Partnership
The aim of this project is to develop a point of care test for diagnosis of active TB based on the measurement of a combination of 7 markers in plasma using a multi-plex lateral flow test. The overall objective of the study is to incorporate the six-marker signature into a multiplex UCP-LFA format, referred to as TransDot, for finger-prick blood testing.
TB Sequel: Research networks for health innovation in sub-Saharan Africa
Contacts: Prof Beate Kampmann and Dr Jayne Sutherland
Funding: German Ministry for Research and Education (BMBF)
A substantial proportion of microbiologically cured TB patients are left with some level of impairment of pulmonary function. Understanding which factors lead to more extensive disease and the pathophysiological basis for this is important. TB-sequel is a multi-site prospective clinical study, enrolling around 1600 patients with newly diagnosed TB in Gambia, Tanzania, South Africa and Mozambique. It aims to determine factors that predict long-term lung sequelae in order to provide avenues for early implementation of new therapeutics. Additionally, we are measuring the socio-economic impact of TB to better understand costs to families associated with TB.
A randomized, controlled, double-blind, phase 3 trial to evaluate the effects of maternal or neonatal pneumococcal conjugate vaccination on pneumococcal
Contact: Dr Ed Clarke, Prof B Kampmann
Funding: Medical Research Council/ Welcome Trust/ DFID Global Health Clinical Trials Scheme
This trial aims to examine novel ways to prevent pneumococcal disease in early infancy. We are evaluating the impact of vaccinating either expectant mothers in the third trimester of pregnancy or newborn infants in the first week of life on vaccine-type pneumococcal carriage in the nasopharynx, compared with the usual EPI schedule in a randomised controlled clinical trial enrolling 600 mothers and their infants. The effects of the alternative schedules on serological responses, memory B-cells, carrier-protein specific T-cells in the infant and pneumococcus-specific responses in breast milk are also being examined as exploratory the endpoints.
A pragmatic trial to quantitatively and qualitatively assess different techniques for the administration of fractional dose of inactivated polio vaccine (IPV)
Contact: Dr Ed Clarke and Dr Adedapo Bashorun
Funding: World Health Oganisaton
Acute shortages of IPV, reflecting unpredicted limitations to manufacturing capacity, have resulted in the WHO recommending that ‘fractional’ (1/5th 0.1mL) doses of the vaccine, administered by the intradermal route. These fractional intradermal doses will need to be delivered in emergency community campaigns. This trial specifically assesses the practicality of delivering such large scale intradermal campaigns in a rural setting in West Africa and is expected to provide key data required by the GPEI and WHO.
The microbiome, antibiotics and vaccine immunogenicity
Contact: Dr Ed Clarke
Funding: Stanford University
This sub-study will be part of the MenAfriVac trial. It will provide an opportunity to monitor the development of the intestinal microbiome from birth to 10 months of age and to assess the effects that any antibiotics, administered in early life for clinical indication, have on this development. Furthermore, to study the downstream effects of distinct microbial profiles on baseline and post-vaccination transcriptomic and metabolomic profiles and immune cell phenotypes, and on the serological responses to vaccination.
Maternal Immunization with MenAfriVac®
Contact: Dr Ed Clarke and Prof Beate Kampmann
Funding: Meningitis Research Foundation (MRF)
This phase 3 trial will assess the potential role of delivering MenAfriVac®, the meningococcal serogroup A conjugate vaccine manufactured by the Serum Institute of India Pvt. Ltd, to expectant mothers to protect their infants. As tetanus toxoid is the conjugated protein, the vaccine could replace one of the routine antenatal doses. MenAfriVac® is currently recommended for infants routinely from 9 months upward. Vaccinating expectant mothers could close the window of susceptibility up to this age.