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SYSTEMS ANALYSIS OF ADULT AND PEDIATRIC RESPONSES TO THE VSV-ZEBOV EBOLA VACCINE - Sofia ref.: 116068

Objective

The vesicular stomatitis virus (VSV)-Zaire Ebola vaccine (VSV-ZEBOV) is a recombinant vector-based vaccine in which the VSV envelope glycoprotein was replaced with the Zaire strain Ebola virus glycoprotein. Within one year of the initiation of its clinical development, the VSV-ZEBOV vaccine has demonstrated safety, immunogenicity and a remarkably high protective efficacy against Ebola Virus Disease, using a high vaccine dose (2x107 pfu) in the WHO-sponsored VSV-ZEBOV ring-vaccination trial in adults in Guinea. However, several key questions remain unanswered, including its mode of action, its correlation with protection and reactogenicity, the expected duration of protective efficacy and determinants of long-term responses, the influence of baseline immunity on vaccine “take”, and the vaccine efficacy in children - a most vulnerable population. Following the interruption of the 2014-2015 Ebola Virus Disease (EVD) outbreak, these questions, being central to the future licensing and use of VSV-ZEBOV, may not be addressed by collecting field data. The VSV-EBOPLUS project therefore proposes to use cutting-edge systems biology approaches to address these key questions, capitalizing on the unique availability of large series of extremely well defined samples from clinical vaccine studies with the VSV-ZEBOV vaccine in three different continents (Europe, Africa, US).

Specifically, the overarching objective of VSV-EBOPLUS is to comprehensively decipher the immune and molecular signatures of adult and pediatric responses elicited by VSV-ZEBOV through systems biology approaches. VSV-EBOPLUS will benefit from harmonized and standardized clinical trial protocols, in almost 1’000 adults, adolescents and children.
We propose:
1) to examine early (days 0 to 7) blood samples from 512 adults injected with graded doses (from 3x103 to 1x108 pfu) of VSV-ZEBOV;

Coordinator

SCLAVO VACCINES ASSOCIATION
Net EU contribution
€ 1 625 000,00
Address
Piazza La Lizza 7
53100 Siena
Italy
Activity type
Research Organisations
Non-EU contribution
€ 0,00

Participants (10)

UNIVERSITE DE GENEVE
Switzerland
Net EU contribution
€ 0,00
Address
Rue Du General Dufour 24
1211 Geneve
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 1 598 000,00
Region
Schweiz/Suisse/Svizzera Région lémanique Genève
MERCK SHARP & DOHME CORP
United States
Net EU contribution
€ 0,00
Address
One Merck Drive
08889 Whitehouse Station Nj
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 4 828 910,00
GOETEBORGS UNIVERSITET
Sweden
Net EU contribution
€ 1 698 750,00
Address
Vasaparken
405 30 Goeteborg
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
Region
Södra Sverige Västsverige Västra Götalands län
UNIVERSITA DEGLI STUDI DI SIENA
Italy
Net EU contribution
€ 1 645 000,00
Address
Via Banchi Di Sotto 55
53100 Siena
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
ACADEMISCH ZIEKENHUIS LEIDEN
Netherlands
Net EU contribution
€ 1 696 875,00
Address
Albinusdreef 2
2333 ZA Leiden
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
Region
West-Nederland Zuid-Holland Agglomeratie Leiden en Bollenstreek
MICROBIOTEC SRL
Italy
Net EU contribution
€ 485 000,00
SME

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

Yes
Address
Via Delle Vigne 12
53035 Monteriggioni
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
Region
Centro (IT) Toscana Siena
 
EBERHARD KARLS UNIVERSITAET TUEBINGEN
Germany
Net EU contribution
€ 395 625,00
Address
Geschwister-scholl-platz
72074 Tuebingen
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
Region
Baden-Württemberg Tübingen Tübingen, Landkreis
UNIVERSIDADE DE SAO PAULO
Brazil
Net EU contribution
€ 306 250,00
Address
Rua Da Reitoria 109 Butanta
05508 900 Sao Paulo Sp
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
EIDGENOSSISCHES DEPARTEMENT FUR VERTEIDIGUNG, BEVOLKERUNGSSCHUTZ UND SPORT
Switzerland
Net EU contribution
€ 0,00
Address
Bundeshaus Ost
CH-3003 Bern
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 450 000,00
Region
Schweiz/Suisse/Svizzera Espace Mittelland Bern / Berne
Centre de Recherches Medicales de Lambaréné
Gabon
Net EU contribution
€ 701 250,00
Activity type
Research Organisations
Non-EU contribution
€ 0,00