Hospital of the Ludwig-Maximilians-University (LMU) Munich, Division of Infectious Diseases and Tropical Medicine
The Ludwig-Maximilians-University (LMU) Munich is one of Germany’s largest universities and is participating in this project with the University Hospital’s Division of Infectious Diseases and Tropical Medicine.
The mission of this department is to improve prevention and treatment of infectious and tropical diseases. It aims at achieving this goal through research, translation of evidence into improved services and policies, and transfer of knowledge. Besides its activities in travel medicine and in providing outpatient and clinical consultant services, the Division of Infectious Diseases and Tropical Medicine houses the German Center for Infection Research (DZIF) international Clinical Trials Unit (iCTU), led by Prof. M. Hoelscher. The iCTU is experienced and equipped to design, organize and conduct clinical trials on new treatments, diagnostics and interventions with focus on improvement of health in low- and middle-income countries. Established through many previous and current collaborations, close research partneships are in place with various Sub-Saharan countries, e.g. Tanzania, Malawi, Mozambique, Ghana, South Africa, Ivory Coast, Ethiopia, The Gambia, and Uganda.
Members of the TherVacB project team are part of an global health research team and the fully functional clinical unit consists of 70 staff members with capabilities in trial design, data management, statistical support, quality monitoring, adverse event/safety management as well in the evaluation of clinical and laboratory endpoints (e.g. immune-phenotyping and assessment of humoral immune responses and epitope mapping).
Well established procedures are in place to facilitate cooperation with local teams of medical doctors, study nurses, laboratory personnel, pharmacists, data management and logistic staff of the local sites, which allowed to successfully perform many interventional trials (e.g. MAMS, SQ109, FATI) in the sponsor role and additionally more than 15 non-interventional studies under the oversight of the iCTU.
Role in TherVacB
Within the TherVacB consortium, the Hospital of the Ludwig-Maximilians-University (LMU) Munich takes the sponsor role for the clinical trial. This includes full responsibility for the GCP-conform conduct of the trial and for protocol compliance during all phases of the project from initiation until analysis of final results. The task of the ‘Sponsor Delegated Person’ is assumed by Prof. M. Hoelscher and the task of ‘Protocol Chair’ and ‘Sponsor’s Medical Expert’ is assumed by Dr. A. Kroidl, who shares the Protocol Chair role with Prof. U. Protzer.
Professor and Director Division of Infectious Diseases and Tropical Medicine
Heading the clinical development programme for HIV and TB drugs and vaccines at the Division of Infectious Diseases and Tropical Medicine. Has the role as sponsor representative on behalf of the Hospital of the Ludwig-Maximilians-University (LMU) Munich for several clinical trials.
Specialist for Internal Medicine Division of Infectious Diseases and Tropical Medicine
Internal medicine and infectious diseases specialist focused on HIV and tropical diseases.
Clinical Project Manager
Expertise in preparation and conduct of international clinical trials phase I-IV, with involvement of sites in Africa.