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In Silico Trial for Tuberculosis Vaccine Development

Objective

Tuberculosis (TB) one of the world’s deadliest diseases: one third of the world’s population, mostly in developing countries, is infected with TB. But TB is becoming again very dangerous also for developed countries, due to the increased mobility of the world population, and the appearance of several new bacterial strains that are multi-drug resistant (MDR). There is now a growing awareness that TB can be effectively fought only working globally, starting from countries like India, where the infection is endemic. Once a person present the active disease, the most critical issue is the current duration of the therapy, because of the high costs it involved, the increased chances of non-compliance (which increase the probability of developing an MDR strain), and the time the patient is still infectious to others. One exciting possibility to shorten the duration of the therapy are new host-reaction therapies (HRT) as a coadjuvant of the antibiotic therapy. The endpoints in the clinical trials for HRTs are time to inactivation, and incidence of recurrence. While for the first it is in some cases possible to have a statistically powered evidence for efficacy in a phase II clinical trial, recurrence almost always require a phase III clinical trial with thousands of patients involved, and huge costs. In the STriTuVaD project we will extend our Universal Immune System Simulator to include all relevant determinants of such clinical trial, establish its predictive accuracy against the individual patients recruited in the trial, use it to generate virtual patients and predict their response to the HRT being tested, and combine them to the observations made on physical patients using a new in silico-augmented clinical trial approach that uses a Bayesian adaptive design. This approach, where found effective could drastically reduce the cost of innovation in this critical sector of public healthcare.

Call for proposal

H2020-SC1-2016-2017

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Sub call

H2020-SC1-2017-CNECT-2

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Coordinator

ETNA BIOTECH SRL
Net EU contribution
€ 1 852 597,55
Address
Strada Vincenzo Lancia 57
95100 Catania
Italy

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Region
Isole Sicilia Catania
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00

Participants (7)

UNIVERSITA DEGLI STUDI DI CATANIA
Italy
Net EU contribution
€ 936 738,75
Address
Piazza Universita 2
95131 Catania

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Region
Isole Sicilia Catania
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
THE UNIVERSITY OF SHEFFIELD
United Kingdom
Net EU contribution
€ 465 323,75
Address
Firth Court Western Bank
S10 2TN Sheffield

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Region
Yorkshire and the Humber South Yorkshire Sheffield
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
ARCHIVEL FARMA, SL
Spain
Net EU contribution
€ 408 360,00
Address
Fogars De Tordera, 61
08916 Badalona

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Region
Este Cataluña Barcelona
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
STICHTING TUBERCULOSIS VACCINE INITIATIVE
Netherlands
Net EU contribution
€ 65 625,00
Address
Runderweg 6
8219 PK Lelystad

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Region
Oost-Nederland Flevoland Flevoland
Activity type
Other
Non-EU contribution
€ 0,00
INFECTIOUS DISEASE RESEARCH INSTITUTE

Participation ended

United States
Net EU contribution
€ 396 334,95
Address
Eastlake Ave E 1616 Ste 400
98102 Seattle Wa

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Activity type
Research Organisations
Non-EU contribution
€ 0,00
THE ALL-INDIA INSTITUTE OF MEDICAL SCIENCES
India
Net EU contribution
€ 0,00
Address
Ansari Nagar
110608 New Delhi

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Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 501 128,75
ALMA MATER STUDIORUM - UNIVERSITA DI BOLOGNA
Italy
Net EU contribution
€ 424 547,50
Address
Via Zamboni 33
40126 Bologna

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Region
Nord-Est Emilia-Romagna Bologna
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00