Centre de Recherches Médicales de Lambaréné
The Centre de Recherches Médicales de Lambaréné (CERMEL), the former “Medical Research Unit of the Albert Schweitzer Hospital”, was established in 1981 as a research centre located in the rain forest region of Gabon in the Central African sub-region. The center has a long history of evaluating interventions against malaria, including phase I to IV drug trials, vaccine candidate evaluations and intermittent preventive treatment in infants and pregnant women. The past years have seen a diversification into other areas such as tuberculosis, as well as bacterial and helminthic infections. A number of epidemiological and social science research projects are performed on a variety of research subjects.
Ifakara Health Institute
Ifakara Health Institute (IHI) is a leading research organization in Africa with a strong track record in developing, testing and validating innovations for health. Driven by a core strategic mandate for research, training and services, the Institute’s work now spans a wide spectrum, covering biomedical and ecological sciences, intervention studies, health-systems research and policy translation. Based on long-lasting research partnerships, IHI has a strong track record for clinical trials in Tanzania, primarily in the field of malaria and tuberculosis. Tuberculosis research at IHI covers clinical trials on new vaccines and new treatment regimens for TB, as well as evaluation of new diagnostics, immunology, co-morbidities, and molecular epidemiology for TB.
For the Makerere University/CISMAC site, the study will be conducted in Kawaala health center III, Kitebi health center III in Kampala district and in Mukono health center IV, which is located in Mukono district, 27 km east of Kampala. The school of Public health, Makerere University has existing collaborations with these health centers and has established a clinical trial infrastructure with ongoing trials. These health centers conduct hundreds of antenatal visits and births each year. In addition, they are located close to laboratories essential for rapid specimen processing.
Max Planck Institute for Infection Biology
The Max Planck Society is Germany’s most successful research organization. Since its establishment in 1948, no fewer than 18 Nobel laureates have emerged from the ranks of its scientists, putting it on a par with the best and most prestigious research institutions worldwide. The Max Planck Institute for Infection Biology was founded in 1993 with Prof. Dr. Dr. h.c. Stefan H.E. Kaufmann as Founding Director. The institute employs multidisciplinary approaches to infection biology comprising concepts and methodologies of molecular genetics, immunology, cell biology, epidemiology, clinical research and protein chemistry. The institute promotes the applications of its research towards paving the way for the design of rational measures to control infectious diseases. The Department of Immunology, at the Max Planck Institute for Infection Biology in Berlin, is the place of origin of VPM1002. Stefan H.E. Kaufmann is advising and supporting the further development of their invention and also performing further research into this vaccine and tuberculosis.
Respiratory and Meningeal Pathogens Research Unit
The Respiratory and Meningeal Pathogens Research Unit (RMPRU) is one of the involved clinical sites in the ongoing phase II VPM1002 infant trial. They have excelled in contributing to the phase II trial. The site is under the Directorship of Professor Shabir A Madhi and has conducted pivotal trials on pneumococcal conjugate vaccine, rotavirus vaccine, maternal influenza vaccination and isoniazid prophylaxis in African HIV- exposed and HIV- unexposed children over the past 21 years.
Stellenbosch University Immunology Research Group (Stellenbosch)
The Stellenbosch University Immunology Research Group (SU-IRG) was established in 2002 within Division of Molecular Biology & Human Genetics, Department of Biomedical Sciences, Faculty of Medicine & Health Sciences, at Stellenbosch University. The Immunology Research Group has since been involved in numerous international and local research collaborations, contributing to the fields of Tuberculosis Immunology, Tuberculosis in the context of comorbidities, including HIV coinfection and Type 2 Diabetes Mellitus and biomarkers for diagnosis, protective immunity and treatment response.
Stichting TuBerculosis Vaccine Initiative (TBVI)
TBVI, the TuBerculosis Vaccine Initiative, is an innovation partnership that works to discover and develop new TB vaccines. It consists of two interdependent arms – the TBVI R&D Partners and the TBVI Organization. The TBVI R&D Partners are responsible for TBVI R&D activities related to discovering and developing new TB vaccines, and relevant biomarkers that can help to develop these vaccines. The TBVI Organization is the services arm of TBVI.
TBVI has developed a unique business model that combines the best practices from innovative consortium models with the strengths of a collaborative R&D support organisation that provides focus, prioritization and an enabling environment
TBVI provides its longstanding project management and coordination expertise to support the coordinator (VPM) in its role to coordinate and manage the project.
Vakzine Projekt Management GmbH
Vakzine Projekt Management GmbH (VPM) is a privately held company in the field of biomedical research and development. Within the last decade, VPM has been successfully developing promising biopharmaceutical candidates. One of this is VPM1002 which has been first developed as own product. After outlicensing, VPM1002 is now developed further together with Serum Institute of India Pvt.Ltd.. Within this project, VPM will be the coordinator of the consortium.
Additionally, VPM offers tailor-made hands-on services and consultancy to biopharmaceutical enterprises, private funding organizations and research groups, based on their in-depth experience and a strong network of reliable partners.
Family Clinical Research Unit
FAM-CRU conducted the initial Phase IIa study with VPM1002 on healthy newborn infants and is one of the four sites participating in the current Phase IIb expanded study that includes HIV-exposed infants. This site was established in 2003 and has experience conducting studies in a setting with high prevalence for TB and HIV. With this long-standing collaboration, the study team is well trained and highly experienced for TB vaccine research.
Kenya Medical Research Institute (KEMRI)
Kenya Medical Research Institute (KEMRI) is a State Corporation established through the Science and Technology (Amendment) Act of 1979, which has since been amended to Science, Technology and Innovation Act 2013. The 1979 Act established KEMRI as a National body responsible for carrying out health research in Kenya. The Kenya Medical research Institute (KEMRI) has multiple research centres including the Centre for Respiratory Diseases Research (CRDR) under which this project will be implemented. CRDR has a full complement of staff experienced in conducting clinical trials and research facilities designed for phase I, II and III trials. CRDR is experienced in both TB-vaccine trials as well as infant trials.
Mecru Clinical Research Unit (MeCRU)
Mecru Clinical Research Unit (MeCRU) is a unit which was established at Sefako Makgatho Health Sciences University from October 2005. The facility was established with the support of the Medical Research Council through the South African AIDS Vaccine Initiative (SAAVI) and was officially opened by Minister of Health, Dr Aaron Motsoaledi, on the 3rd of June 2010. It is located at the Sefako Makgatho Health Sciences University (SMU) where there is wide spectrum of qualified specialists in health who have varying degrees of competence in research and clinical work. The SMU is attached to Dr George Mukhari Academic Hospital, a 1400 bed tertiary hospital a tertiary hospital used for the training of health professionals.
Medical Research Council/Uganda Virus Research Institute
The proposed trial will be conducted within the Entebbe Mother and Baby Study (EMaBS) clinic in collaboration with the Entebbe Hospital located within the same environs. The EMaBS birth cohort was established in 2002 to investigate the effects of helminths and their treatment on immune responses to vaccines and on susceptibility to infectious and allergy-related diseases. EMaBS is under the Immunomodulation and Vaccines (I-Vac) programme of the MRC/UVRI and LSHTM Uganda Research Unit. They have a long-standing interest in improving the understanding of BCG immunisation in tropical settings and have carried out several studies on BCG. These include investigating the impact of maternal worm infections on the infant immune response to BCG, and the effects of maternal latent tuberculosis infection on the immune response to BCG in infants. They have also compared the immunogenicity of different BCG strains and examined the non-specific benefits of BCG immunisation.
South African TB Vaccine Initiative
The South African TB Vaccine Initiative (SATVI), based at the University of Cape Town is a co-research site in the ongoing phase II VPM1002 infant trial. SATVI is a tuberculosis (TB) research group with a research scope that spans several disciplines including paediatrics, infectious diseases, epidemiology, public health, immunology, systems biology and clinical sciences. Their 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. Clinical trials are conducted in phases amongst small groups of people in the early phases (phases I and II) and amongst larger groups of people once safety has been determined (phases III and IV). In the proposed phase III trial they will extend their work and contribute to this trial.
Serum Institute of India Pvt. Ltd.
Serum Institute of India Pvt. Ltd. is now the world’s largest vaccine manufacturer by number of doses produced and sold globally (more than 1.3 billion doses). Serum Institute of India was founded in 1966 by Dr. Cyrus Poonawalla with the aim of manufacturing life-saving immuno-biologicals, which were in shortage in the country and imported at high prices. Thereafter, several life-saving biologicals were manufactured at prices affordable to the common man. In 2012 they acquired the license for VPM1002 and took over the development of this vaccine candidate. Serum Institute of India will be the IMP manufacturer and sponsor within this trial.
University of Tübingen
The Institute of Tropical Medicine (ITM) at the University Clinics Tübingen (UKT) is an established and well connected research entity located in the university town of Tübingen in southern Germany. It is funded by the government and public grants and its main purpose is to perform research, teaching and medical care in the field of tropical medicine. A focus of the clinical research group is innovative studies on humans. This includes Phase 1-3 trials, experimental infections and experimental medicine studies in Tübingen and as part of consortia with international partners including Africa. ITM-UKT has been investigator and sponsor of clinical trials and has an infrastructure for conduct, quality control and training in place. Scientific activities include vaccinology, tuberculosis and malaria research as well as human immunology. The group has decades of experience in training and technology transfer to affiliated institutions in Europe and several African countries. Post navigation