The POR consortium consists of eight internationally recognized research institutions
Statens Serum Institut
Statens Serum Institut (Denmark)
Statens Serum Institut (SSI) is a public health institute, within the Ministry of Health in Denmark. SSI aims to ensure advanced control of infectious diseases, including new infectious and biological threats. The Institute also strives to be a highly regarded and recognized international research and service enterprise. The Center for Vaccine Research consists of three departments: The Department of Infectious Disease Immunology, The Department of Vaccine Development and The Department for Quality Assurance and Quality Control. The Center for vaccine Reasearch is internationally recognized for its vaccine research, development and clinical pipeline, participating in many international collaborations.
Key personnel involved from SSI:
- Peter Andersen: Executive Vice President, Center for Vaccine Research
- Morten Ruhwald: Chief Medical Officer, Center for Vaccine Research
- Ingrid Kromann, Director of Vaccine Development, Center for Vaccine Research
- Kjersti Moen: Head of Section, cClinical development, Center for Vaccine Research
- Grith Krøyer Wood, Head of Section, Vaccine Formulation, Center for Vaccine Research
- Solveig Walløe Harpøth, Head of Section, Administration, Center for Vaccine Research
Areas Global TB Vaccine Foundation NPC (South Africa)
Aeras Global TB Vaccine Foundation NPC (South Africa) is registered in South Africa as a non-profit organization under the auspices of IAVI, the International AIDS Vaccine Initiative developing new, safe and effective TB vaccines that are affordable and accessible to all who need them. Aeras Africa has conducted 17 clinical trials within TB vaccines since 2008 across Africa.
Key Personnel involve from Aeras Africa:
- Dereck Tait: Clinical Director & Office Lead
- Kristin Croucher, Senior Director Clinical Operations
Ospedale San Raffaele
Ospedale San Raffaele (Italy)
The Emerging Bacterial Pathogens Unit, Ospedale San Raffaele (OSR) (Italy): OSR is recognized by the Italian Ministry of Health as a Research Hospital (IRCCS). It comprises both clinical and research activities, and performs cutting-edge science aiming at advancing the knowledge about human diseases and novel therapies through translational research. The Emerging Bacterial Pathogens Unit is part of the Division of Immunology, Transplantation and Infectious Diseases and consists of fully equipped and certified molecular bacteriology and BSL2/3 laboratories. The Unit is hosting a WHO Collaborating Centre in Tuberculosis Laboratory Strengthening, a Tuberculosis Supranational Reference Laboratory (it is currently supporting at various levels 12 Countries located in Africa, Asia and Eastern Europe) and an ESCMID Collaboration Centre. The staff includes mycobacteriologists, molecular biologists, bioinformatics and laboratory technicians with specific training to provide External Quality Assessment and large experience in supporting Countries to introduce new molecular diagnostics for the diagnosis of TB and DR-TB.
Key Personnel involved from Ospedale San Raffaele:
- Daniela Cirillo, MD, PhD, Head of Emerging Bacterial Pathogens Unit
- Andrea Maurizio Cabibbe, PhD, Emerging Bacterial Pathogens Unit
South African Tuberculosis Vaccine Initiative
South African Tuberculosis Vaccine Initiative (South Africa)
The South African Tuberculosis Vaccine Initiative (SATVI) is a tuberculosis (TB) research group with a research scope that spans several disciplines including pediatrics, infectious diseases, epidemiology, public health, immunology, systems biology and clinical sciences. Our research focus is understanding the risk for, and protection against, M. tuberculosis infection and TB disease, in order to develop more effective vaccines and preventive strategies.
SATVI has a large and well-developed clinical field site in the Boland Overberg region, with the core facility on the premises of the Brewelskloof TB Hospital in Worcester, from where most clinical/epidemiological studies and clinical trials are conducted. The clinical trials research is led by SATVI Director, Professor Mark Hatherill, and the immunology and laboratory-based research is led by SATVI Deputy Director, Professor Tom Scriba.
SATVI was established in 2001 at the University of Cape Town (UCT) and has developed into a sophisticated, world-class TB clinical research centre with state of the art immunology laboratories located within the Institute of Infectious Disease and Molecular Medicine (IDM) of the University of Cape Town. Our laboratories are accredited and adhere to the highest international standards. In addition to our track record in TB vaccine development, our recent work builds on discovery of prognostic biomarkers for TB disease to test screen & treat strategies, based on biomarker-targeted TB preventive therapy.
Key personnel involved from SATVI:
- Mark Hatherill, Professor, Director
- Tom Scriba, Professor, Deputy director
- Justin Shenje, Dr., Clinical investigator
- Elisa Nemes, Dr.,Senior research officer
The Aurum Institute
The Aurum Institute, NPC (South Africa)
The Aurum institute has been in existence for almost 21 years and was founded by current CEO Professor Gavin Churchyard. Aurum proudly boasts it has enrolled in excess of 92 000 clinical research participants during this period. Aurum is an experienced institution that has run numerous clinical trials; ranging from large scale public health studies, to highly regulated clinical trials of new medications.
The Clinical Research Division’s (one of 5 major divisions) staff are employed across 3 main Clinical Research Centres in Klerksdorp, Tembisa and Rustenburg. All three sites conduct research within all 5 key defined programmatic areas: i.) TB Vaccines, ii.) HIV Vaccines, iii.) HIV Treatment and PreP, iv.) TB Treatment and iv.) Basic Sciences and Special Projects each managed by a dedicated Programme Manager and an overarching HoD of Clinical Research Projects (Trevor Beattie) in addition to the site based management team. Each site has a dedicated full time CRS Leader / PI and supporting Medical Officers, Nurses, Study Co-ordinators, Quality Assurance and Control Officers, Data Capturers, Research assistants (Recruitment and Retention), Drivers, Operations Managers and General Assistants. Each Clinical Research Centre has access to various key populations, has established Community Advisory Boards and boast an impressive of trials (both network and Investigator Initiated) in each of the 5 key Programmatic areas. We have conducted more than 60 clinical trials. All of the 300+ staff employed in the Clinical Research Division have many years of experience in the field of clinical research specifically and are highly skilled and GCP trained. Our pipeline of work for 2018 through 2020 shows we have well-skilled pluripotent sites working across a range of protocols at various stages of delivery, testament to our proven track record and high quality standards. Key populations within (including healthy volunteers) the division include:
- IGRA+ve HIV –ve individuals – Prevention of TB Disease
- DS-TB+ HIV-ve and HIV+ve populations – TB Treatment / Prevention of TB Recurrence
- High-risk young (18-30 years of age) HIV-ve females – Prevention of HIV Infection
- Female sex-workers (SW) – Prevention of HIV Infection / Correlates of Risk
- MSM (Men who have sex with men) populations – Prevention of HIV Infection
- Household Contacts of DS-TB / Rif-R Index Cases
- Access to Adolescents – Prevention of Infection (TB / HIV)
The Klerksdorp CRC is involved in the Prevention of Recurrence TB Vaccine trial and is a POR consortium member. The Klerksdorp CRC will be identifying up to 900 DS TB+ve individuals in the Dr Kenneth Kaunda district in the North West Province of South Africa, who will be prospectively traced until 5 months of TB treatment has been completed with expected clinical cure before being enrolled. 180 subjects eligible for vaccination will be vaccinated on days 0 and 56 and followed up for approximately 12 months after 2nd vaccination.
Key Personnel involved from The Aurum Institute:
- Gavin Churchyard, Professor, Group CEO
- Craig Innes, Dr., Clinical Director, Clinical research Division
- Pearl Selepe, Dr., Site Principal Investigator, Clinical Research Division
- Trevor Beattie, HoD:Projects, Clinical Research Division
- Nishanee Arjune, Program Manager, TB Vaccines
TASK Applied Science
TASK Applied Science (South Africa)
TASK is a social enterprise committed to developing novelty medicines, vaccines and diagnostics that help improve global health care. As an established centre for TB vaccine and anti-TB drug trials, TASK operates clinical trial sites in multiple urban areas in Cape Town, South Africa, which has a high incidence of recurrent TB. This setting is ideal to test POR in a real-world scenario. This project will build on TASK’s already extensive experience with large scale TB drug and vaccination trials including H56:IC31.
Established in 2005 by the physician Professor Andreas Diacon as a TB clinical trial site, TASK has since grown to a 100-plus staff, including scientists, doctors and researchers. These key individuals and teams are deployed at five clinical sites within the Western Cape and at a Biosafety Level 3 Laboratory in Parow, Cape Town.
As a social good organisation, TASK has immersed itself within the communities of the Western Cape, boasting healthy relationships with community clinics and local health authorities, this in part through ongoing community engagement programs aimed at improving the lives and health of the community in which TASK operates.
TASK is the leading global player in early phase TB medicine evaluation. The trials conducted TASK’s Clinical Trial Centre in Bellville and the TASK Laboratory in Parow play a critical role in the development of new TB drugs. These studies determine within two weeks whether a new candidate medication is indeed having a positive effect in TB patients. These tests shape the development pipeline for new TB medicines and as such are critical in the fight against TB.
Key Personnel involved from TASK includes:
- Andreas Diacon: Founder and CEO of TASK Applied Science and TASK NPC
- Elana van Brakel: Investigator
The University of Cape Town, Lung Institute
The University of Cape Town Lung Institute (South Africa)
The University of Cape Town Lung Institute (UCTLI) is a public benefit organization (PBO) that addresses priority health issues through education, research and service. The UCTLI has extensive experience with large scale TB drug and vaccine studies. The UCTLI has conducted over 20 Phase II and III clinical trials of novel TB drugs and combinations, including new compounds such as Bedaquiline, Delamanid and Pretomanid. The UCTLI has a state of the art drug and vaccine development facility and an active clinical trial programme with all required regulatory and GCP monitoring and evaluation standards in place with extensive experience in managing EDCTP clinical trials.
Key Personnel involved from UCTLI includes:
- Rod Dawson: Managing Director UCTLI
- Kim Narunsky: Unit Manager: Centre for TB Research Innovation, UCTLI
- Bernice Zabow: Clinical Trial Manager, UCTLI
- Debbie Carstens: Regulatory manager, UCTLI
Mbeya Medical Research Center
Mbeya Medical Research Center (Tanzania)
The National Institute for Medical Research (NIMR) -Mbeya Medical Research Center (MMRC) has been one of Tanzania’s most active research centers with longstanding partnerships with the U.S. Military HIV Research Program (MHRP) and the University of Munich (LMU) in Germany. In November 2010, MMRC officially became one of eight medical research centers of NIMR, which operates under the Tanzanian Ministry of Health, Community Development, Gender, Elderly and Children. In an effort to expand and strengthen its HIV clinical trial capabilities, NIMR-MMRC joined the HIV Vaccine Trials Network (HVTN) in 2014 as part of the MHRP Clinical Trials Unit.
Over the past decades, NIMR-MMRC has grown to become one of Tanzania’s most active research centers across a broad range of infectious diseases. NIMR-MMRC has diversified its activities to create synergies and use its technical infrastructure for multiple disease areas, such as HIV (vaccines, drugs and diagnostics trials); Tuberculosis (drugs, diagnostics and vaccines trials) and major co-morbidities such as helminthic infections and human papilloma virus (HPV). Research activities are supported by an active Community Advisory Board (CAB), which was created in 2005 as part of an effort to facilitate dialogue between community members, study volunteers and the research team.
NIMR-MMRC has also demonstrated success in recruitment of difficult sub-populations such as sex workers, children, remotely living individuals and prisoners. Research projects are organized under three main departments that correspond to the three main areas of research of the center; HIV and Reproductive Health, Tuberculosis and Emerging Diseases and Social Sciences and Community Engagement. Supporting departments include Administration, ICT, Data management and Finance.
Key personnel involved from NIMR-MMRC:
- Nyanda Elias Ntinginya: Center Director
- Lucas Maganga: Head of HIV and Reproductive Health
- Issa Sabi: Head of Tuberculosis and Emerging Diseases
- Bariki Mtafya, Head of Laboratory Sciences
- Doreen Pamba, Head of Social Sciences and Community Engagement