Title Address Description
LMU
GESCHWISTER SCHOLL PLATZ 1, 80539 München,

Hospital of the Ludwig-Maximilians-University (LMU) Munich, Division of Infectious Diseases and Tropical Medicine

Fundació Clínic per a la Recerca Biomèdica
Carrer del Rosselló, 149, 08036 Barcelona, Spanien

Fundació Clínic per a la Recerca Biomèdica

Helmholtz-Zentrum für Infektionsforschung GmbH (HZI)
Ingolstädter Landstraße 1, 85764 Oberschleißheim, Deutschland

Helmholtz-Zentrum für Infektionsforschung GmbH (HZI)

Helmholtz Munich
Inhoffenstraße 7, 38124 Braunschweig, DeutschlandHelmholtz Munich
Medizinische Hochschule Hannover
Carl-Neuberg-Straße 1, 30625 Hannover, Deutschland

MHH

NIMR-Mbeya Medizinisches Forschungszentrum
Hospital Hill Rd, Mbeya, Tansania

NIMR-Mbeya Medizinisches Forschungszentrum

Technische Universität München
Arcisstraße 21, 80333 München, Deutschland

汤姆

UNIVERSITY COLLEGE LONDON (UCL)
GOWER STREET, WC1E 6BT London

UNIVERSITY COLLEGE LONDON (UCL)

Klinikum Rechts der Isar der Technischen Universität München
Hörsaal A, Klinikum rechts der Isar, Ismaninger Str. 22, 81675 München, Deutschland

Klinikum Rechts der Isar der Technischen Universität München

UKE Hamburg Eppendorf
Martinistraße 52, 20251 Hamburg, DeutschlandUKE Hamburg Eppendorf
Azienda Ospedaliero- Universitaria di Parma
Str. dell'Università, 12, 43121 Parma PR, ItalienAzienda Ospedaliero- Universitaria di Parma
Universitätsklinikum Leipzig
Ritterstraße 26, 04109 Leipzig, DeutschlandUniversitätsklinikum Leipzig
Barts Health NHS Trust
Co-operative Bank Plc, 9 Prescot St, Whitechapel, London E1 8AZ, Vereinigtes Königreich

Barts Health NHS Trust

Royal Free London NHS Foundation Trust
Pond St, Hampstead, London NW3 2QG, Vereinigtes Königreich
PNO Innovation GmbH
Oskar-von-Miller-Ring 29, 80333 München, Germany

PNO Innovation GmbH

SocraTec R&D GmbH
Im Setzling 35, 61440 Oberursel (Taunus), DeutschlandSocraTec R&D GmbH
Universitätsklinikum Frankfurt
Theodor-Stern-Kai 7, 60596 Frankfurt am Main, Deutschland

Universitätsklinikum Frankfurt

Hospital of the Ludwig-Maximilians-University (LMU) Munich, Institute of Infectious Diseases and Tropical Medicine

General Information

The Ludwig-Maximilians-University (LMU) Munich is one of Germany’s largest universities and is participating in this project with the University Hospital’s Institute of Infectious Diseases and Tropical Medicine.

The mission of this institute 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 Institute 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.

LMU

Hospital of the Ludwig-Maximilians-University (LMU) Munich

Institute of Infectious Diseases and Tropical Medicine

Leopoldstraße 5
80802 Munich
Germany

www.lmu-klinikum.de/tropical-institute

Role in TherVacB

Within the TherVacB consortium, the Hospital of the Ludwig-Maximilians-University (LMU) Munich assumes the sponsor’s 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. Additionally, the Hospital will serve as clinical trial site in the TherVacB clinical study.

Project Staff

 

Michael Hoelscher

Michael Hoelscher

Professor and Director Institute of Infectious Diseases and Tropical Medicine

Heading the clinical development programme for HIV and TB drugs and vaccines. Has the role as sponsor representative on behalf of the Hospital of the Ludwig-Maximilians-University (LMU) Munich for several clinical trials.

Christian Lange

Christian Lange

Professor of Hepatology at the LMU University Hospital

Specialist in internal medicine, gastroenterology and hepatology

Arne Kroidl

Arne Kroidl

Specialist for Internal Medicine Institute of Infectious Diseases and Tropical Medicine

Internal medicine and infectious diseases specialist focused on HIV and tropical diseases.

Otto Geisenberger

Otto Geisenberger

Clinical Project Manager

Expertise in preparation and conduct of international clinical trials phase I-IV, with involvement of sites in Africa.

TherVacB