The consortium and its partners
The MTBVACN3 consortium is composed of nine partners in total, with three European and six sub-Saharan African partners.
- Four participants are Universities and Higher Education Institutions (SATVI/UCT, SUN, Unizar, WHC)
- Three are Research Organizations (IPM, CRB-EPLS, ECF)
- One is a product development partnership supporting and coordinating TB vaccine development (TBVI)
- One is private industry (BIOFABRI)
For this efficacy trial, the Consortium is composed of six recruiting sites. Four in South Africa,, one in Senegal and one in Madagascar.
The project builds upon a group of TB vaccine development partners in Europe and sub-Saharan Africa established in a previous EDCTP-supported project Phase 2a dose-defining study of MTBVAC . It creates an expanded consortium of clinical trial partners for the optimal implementation of a large infant efficacy trial of MTBVAC in high TB incidence settings.
New capacity for efficacy trials in infants will be a valuable resource for the TB vaccine development community. The project creates a network of institutions in three TB endemic African countries with enhanced laboratory capacity to conduct TB vaccine immunology studies and to bio-bank samples to discover immune correlates of vaccine-mediated protection.
The Consortium partners:
Biofabri is the coordinator of this project. It has extensive experience accumulated over decades with live mycobacterial vaccines and is the manufacturer of the MTBVAC vaccine for the trial. Biofabri has successfully conducted the Phase 1b clinical trial, the results of which were published in Lancet Respiratory in August 2019. Biofabri is also conducting the Phase 2a clinical trial of MTBVAC.
TCD / FHI Clinical SA: Triclinium Clinical Development (TCD) is a Clinical Research Organization (CRO) headquartered in Centurion (Pretoria), South Africa, providing end-to-end clinical development services. Recently TCD became part of FHI Clinical. The new organisation, called FHI Clinical SA will provide both operational services such as regulatory, regional project management, clinical monitoring & site management, medical monitoring & pharmacovigilance as well as back-end services such as data management, biostatistics and medical writing to support clinical research activities across the Sub-Saharan region. For on-site monitoring activities, FHI-Clinical SA will deploy its personnel located strategically across Sub-Saharan region.
TBVI provides its longstanding project management and coordination expertise to support the coordinator (Biofabri) in its role to coordinate and manage the MTBVACN3 project. In addition, TBVI provides its regulatory and clinical expertise to advice on the immunological, clinical and capacity building activities.
University of Zaragoza (Unizar): As the discoverer and initial developer of MTBVAC, Unizar works in close collaboration with industrial partner Biofabri providing longstanding preclinical, immunological and scientific expertise on the molecular bases of attenuation and protection of MTBVAC. As part of the EDCTP MTBVACN3 project, Unizar will provide advise on the proposed immunological, clinical and capacity building activities and scientific support to the project management activities. Unizar will also provide scientific advice to all partners on the Clinical Trial Protocols and corresponding immunological studies and will contribute to the immunological validation of once-identified TB-diagnostic test suitable for MTBVAC clinical evaluation and the coordination of immunological studies.
SATVI/UCT SATVI is a university-accredited TB research centre established in 2001 and located within the University of Cape Town (UCT), South Africa. It is the largest dedicated TB vaccine research group on the African continent. SATVI’s research scope spans several disciplines including paediatrics, infectious diseases, epidemiology, public health, immunology, systems biology and clinical sciences. Its primary mission is the development of new and effective vaccination strategies against TB. It’s research focus is understanding the risk for and protection against TB infection and disease in order to develop more effective vaccines, better diagnostic tools and preventive strategies. As partner to the Phase 3 trial, SATVI will utilize its extensive experience to carry out the clinical trial and capacity building activities of the grant.
SUN, the University of Stellenbosch, will provide its clinical trial infrastructure and expertise gained over 17 years in conducting both vaccine and therapeutic registration studies in young infants. The trial will be conducted through the Family Center for Research with Ubuntu (FAMCRU).
ECF, The Enhancing Care Foundation, clinical trials unit in eThekwini, South Africa is based at the King Edward VIII Hospital (KEH) and Wentworth hospital (WWH). KEH is a large regional hospital has over 800 beds and sees approximately 22 000 outpatients a month while WWH is a small district level hospital. For this MTBVACN3-trial, ECF will provide all clinical trial infrastructure including physical environment, technical and human resources required to conduct the clinical study in Durban, South Africa
Wits-VIDA With more than 25 years of experience performing clinical trials, including TB vaccine trials, and conveniently situated at the Chris Hani Baragwanath Hospital in Soweto, the Wits Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA) has been instrumental in enrolling large numbers of participants in pivotal vaccine trials and generally has a retention rate of >95%. Wits-VIDA will provide their extensive clinical trial experience, infrastructure and expertise to successfully conduct the trial.
CRB-EPLS in Senegal provides their extensive local, clinical and immunological expertise to MTBVAC safety and immunological evaluation in newborns and research of potential biomarkers of vaccine-induced protection.
IPM in Madagascar will provide their local immunological, clinical and epidemiological expertise to develop their site to a prospective late-stage TB vaccine clinical trial site. It will provide local expertise to MTBVAC safety and immunological evaluations in newborns and research of potential biomarkers of vaccine-induced protection.