Cohort profile: Translational Platform HIV of the German …¶ffentlichungen/Cohort...and elite...
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Cohort profile: Translational Platform HIV of the German Centre for Infection Research M. Stecher 1,8 , G. Behrens 2,9 , O. Degen 3,10 , R. Draenert 4,10 , J. Bogner 4,10 , H.G. Kräusslich 5,12 , J.Rockstroh 6,13 , B. Gunsenheimer-Bartmeyer 7 , O. Hamouda 7 , C. Lehmann 1,8 , D. Gillor 1,8 , F. Klein 1,8 , G.Fätkenheuer 1,8 , J.-J. Vehreschild 1,8 1 University Hospital of Cologne, Cologne, Germany 2 Hannover Medical School, Hannover, Germany 3 University Hospital Hamburg-Eppendorf, Hamburg, Germany 4 University Hospital Munich, Munich, Germany 5 University Hospital of Heidelberg, Heidelberg, Germany 6 University Hospital of Bonn, Bonn, Germany 7 Robert-Koch-Institute, Berlin, Germany 8 German Center for Infection Research (DZIF), partner site Bonn-Cologne, Germany 9 German Center for Infection Research (DZIF), partner site Hannover, Germany 10 German Center for Infection Research (DZIF), partner site Hamburg, Germany 11 German Center for Infection Research (DZIF), partner site Munich, Germany 12 German Center for Infection Research (DZIF), partner site Heidelberg, Germany 13 Germany German Center for Infection Research (DZIF), partner site Bonn-Cologne, Bonn, Germany Potential new treatment strategies targeting HIV viral reservoirs and immunity come with new challenges for clinical researchers and physicians. Key strategies for the development of HIV cure approaches include exploration of HIV immune surveillance as well as early intervention strategies prior to the establishment of viral reservoirs. There is growing demand for quality-assured biomaterial samples and medical data of patients from rare subgroups, i.e. elite controllers and acute/early HIV infection. Figure 1: Innovative cohort structure Focus on HIV cure has been identified as a priority Recruitment of specific patient groups (individuals with acute/early HIV infection and elite controllers). Expansion of the regional network with specialized HIV practices Expansion of international research collaborations Strengthening translational research Epidemiological, clinical and experimental research projects Interdisciplinary research projects We developed a data safety concept, ethical and legal clearance documents, as well as biobanking protocols HIV Engaged Research Technology (HEnRY) (Figure 1). All are provided free of charge to national collaborators, including university hospitals and private practices. A central service facility (Cologne) offers comprehensive support, including all correspondence with ethics committees and regulators, study hotline, statistical analyses, data management, and clinical trial assistance. The TP-HIV works in close cooperation with the Robert-Koch-Institute (RKI), which provides the documentation platform HIV Observational System (HIObS), allowing seamless integration of the TP-HIV into the German national ClinSurv cohort (Figure 1). Our network comprises six university hospitals and 12 specialized HIV practices throughout Germany; it currently serves as a platform for seven clinical, experimental, and epidemiological studies actively recruiting patients (Figure 2). With support of the German Centre for Infection Research, we developed the Translational Platform HIV (TP-HIV) to address these pressing needs in the German research environment. The aim of the TP-HIV is to create an effective translational chain working both ways: From bench to bedside by providing access to rare patient groups, thus allowing early phase clinical trials with new drug candidates; and back to the bench by providing access to detailed clinical data and well-characterised samples for generating and testing research hypotheses. Unified software platform Common study protocol and biobanking concept Comprehensive data protection concept Full service for translational research: feasibility studies protocol development ethics committee and regulatory approval data warehouse biomaterial exchange statistical analysis Cooperation with Robert-Koch-Institut, Thematic Translational Unit (TTU) International Integrated Reporting Council (IIRC), TI Biobanking The TP-HIV is an innovative new multicentre cohort with a comprehensive collection of biomaterials and medical data that effectively incorporates rare patient groups, i.e. elite controllers and patients with acute and early HIV infection. This unique platform structure allows expedited translational research from bench to bedside and back by structural harmonisation and centralised services, reducing project overheads and regulatory burden for investigators. Corresponding Author: Melanie Stecher, [email protected], +49 221 47886977 Jörg-Janne Vehreschild, [email protected] www.idcohorts.net www.InfektiologieKoeln.de www.ClinicalSurveys.net www.DZIF.de Multicentre cohort database with acute HIV infected individuals – recruitment started (Figure 3) Clinical trial, broadly neutralizing antibodies (F. Klein) – recruitment startet Survey of HIV-positive persons tolerability of vaccination against VZV or MMRs (C. Schwarze-Zander & J. Rockstroh) - peer review process A prospective observational study to characterize immature platelet fraction (IPF) and thrombocyte activation and function alteration in HIV-patients in context of cardiovascular disease (C.D. Spinner) – recruitment started Changes on the intestinal flora and long lasting immune dysfunction (U. Spengler) - under development Analysis of the HIV reservoir (J. Schulze zu Wiesch & G. Behrens) – under development Characterization of the HIV-1 Transmission network in Germany (M. Hoenigl) – under development P-012 Figure 2: Multicentric research network TP-HIV. Results Background Method Conclusion Future Plans 2016-2020 Current Projects Expedited research from bench to bedside and back 3 10 14 15 0 5 10 15 20 25 30 35 40 45 50 Number of patients Timeline Target Actual state Extrapolated Linear (Actual state) Figure 3: Recruitment status of the TopHIV cohort (status at 07.06.2016).
Transcript of Cohort profile: Translational Platform HIV of the German …¶ffentlichungen/Cohort...and elite...
Cohort profile: Translational Platform HIV of the German Centre for Infection Research
M. Stecher1,8, G. Behrens2,9, O. Degen3,10, R. Draenert4,10, J. Bogner4,10, H.G. Kräusslich5,12, J.Rockstroh6,13, B. Gunsenheimer-Bartmeyer7, O. Hamouda7, C. Lehmann1,8, D. Gillor1,8, F. Klein1,8,
G.Fätkenheuer1,8, J.-J. Vehreschild1,8
1 University Hospital of Cologne, Cologne, Germany 2 Hannover Medical School, Hannover, Germany 3 University Hospital Hamburg-Eppendorf, Hamburg, Germany 4 University Hospital Munich, Munich, Germany 5 University Hospital of Heidelberg, Heidelberg, Germany 6 University Hospital of Bonn, Bonn, Germany 7 Robert-Koch-Institute, Berlin, Germany 8German Center for Infection Research (DZIF), partner site Bonn-Cologne, Germany 9German Center for Infection Research (DZIF), partner site Hannover, Germany 10German Center for Infection Research (DZIF), partner site Hamburg, Germany 11German Center for Infection Research (DZIF), partner site Munich, Germany 12German Center for Infection Research (DZIF), partner site Heidelberg, Germany 13Germany German Center for Infection Research
(DZIF), partner site Bonn-Cologne, Bonn, Germany
Potential new treatment strategies targeting HIV viral reservoirs and immunity come with new challenges for clinical researchers and physicians. Key strategies for the development of HIV cure approaches include exploration of HIV immune surveillance as well as early intervention strategies prior to the establishment of viral reservoirs. There is growing demand for quality-assured biomaterial samples and medical data of patients from rare subgroups, i.e. elite controllers and acute/early HIV infection. Figure 1: Innovative cohort structure
Focus on HIV cure has been identified as a priority Recruitment of specific patient groups (individuals with acute/early HIV infection
and elite controllers). Expansion of the regional network with specialized HIV practices Expansion of international research collaborations Strengthening translational research Epidemiological, clinical and experimental research projects Interdisciplinary research projects
We developed a data safety concept, ethical and legal clearance documents, as well as biobanking protocols HIV Engaged Research Technology (HEnRY) (Figure 1). All are provided free of charge to national collaborators, including university hospitals and private practices. A central service facility (Cologne) offers comprehensive support, including all correspondence with ethics committees and regulators, study hotline, statistical analyses, data management, and clinical trial assistance. The TP-HIV works in close cooperation with the Robert-Koch-Institute (RKI), which provides the documentation platform HIV Observational System (HIObS), allowing seamless integration of the TP-HIV into the German national ClinSurv cohort (Figure 1). Our network comprises six university hospitals and 12 specialized HIV practices throughout Germany; it currently serves as a platform for seven clinical, experimental, and epidemiological studies actively recruiting patients (Figure 2).
With support of the German Centre for Infection Research, we developed the Translational Platform HIV (TP-HIV) to address these pressing needs in the German research environment. The aim of the TP-HIV is to create an effective translational chain working both ways: From bench to bedside by providing access to rare patient groups, thus allowing early phase clinical trials with new drug candidates; and back to the bench by providing access to detailed clinical data and well-characterised samples for generating and testing research hypotheses.
Unified software platform Common study protocol and biobanking concept Comprehensive data protection concept Full service for translational research: feasibility studies protocol development ethics committee and regulatory approval data warehouse biomaterial exchange statistical analysis
Cooperation with Robert-Koch-Institut, Thematic Translational Unit (TTU) International Integrated Reporting Council (IIRC), TI Biobanking
The TP-HIV is an innovative new multicentre cohort with a comprehensive collection of biomaterials and medical data that effectively incorporates rare patient groups, i.e. elite controllers and patients with acute and early HIV infection. This unique platform structure allows expedited translational research from bench to bedside and back by structural harmonisation and centralised services, reducing project overheads and regulatory burden for investigators.
Corresponding Author: Melanie Stecher, [email protected], +49 221 47886977 Jörg-Janne Vehreschild, [email protected]
www.idcohorts.net www.InfektiologieKoeln.de www.ClinicalSurveys.net www.DZIF.de
Multicentre cohort database with acute HIV infected individuals – recruitment started (Figure 3)
Clinical trial, broadly neutralizing antibodies (F. Klein) – recruitment startet Survey of HIV-positive persons tolerability of vaccination against VZV or
MMRs (C. Schwarze-Zander & J. Rockstroh) - peer review process A prospective observational study to characterize immature platelet fraction
(IPF) and thrombocyte activation and function alteration in HIV-patients in context of cardiovascular disease (C.D. Spinner) – recruitment started
Changes on the intestinal flora and long lasting immune dysfunction (U. Spengler) - under development
Analysis of the HIV reservoir (J. Schulze zu Wiesch & G. Behrens) – under development
Characterization of the HIV-1 Transmission network in Germany (M. Hoenigl) – under development
P-012
Figure 2: Multicentric research network TP-HIV.
Results
Background Method
Conclusion Future Plans 2016-2020
Current Projects
Expedited research from bench to bedside and back
3
10 14 15
0
5
10
15
20
25
30
35
40
45
50
Num
ber o
f pat
ient
s
Timeline
Target Actual state Extrapolated Linear (Actual state)
Figure 3: Recruitment status of the TopHIV cohort (status at 07.06.2016).
