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

SYSTEMS ANALYSIS OF ADULT AND PEDIATRIC RESPONSES TO THE VSV-ZEBOVEBOLA 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;
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Coordinator

SCLAVO VACCINES ASSOCIATION

Address

Piazza La Lizza 7
53100 Siena

Italy

Activity type

Research Organisations

EU Contribution

€ 1 625 000

Participants (10)

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UNIVERSITE DE GENEVE

Switzerland

MERCK SHARP & DOHME CORP

United States

GOETEBORGS UNIVERSITET

Sweden

EU Contribution

€ 1 698 750

UNIVERSITA DEGLI STUDI DI SIENA

Italy

EU Contribution

€ 1 645 000

ACADEMISCH ZIEKENHUIS LEIDEN

Netherlands

EU Contribution

€ 1 696 875

MICROBIOTEC SRL

Italy

EU Contribution

€ 485 000

EBERHARD KARLS UNIVERSITAET TUEBINGEN

Germany

EU Contribution

€ 395 625

UNIVERSIDADE DE SAO PAULO

Brazil

EU Contribution

€ 306 250

EIDGENOSSISCHES DEPARTEMENT FUR VERTEIDIGUNG, BEVOLKERUNGSSCHUTZ UND SPORT

Switzerland

Centre de Recherches Medicales de Lambaréné

Gabon

EU Contribution

€ 701 250

Project information

Grant agreement ID: 116068

Status

Ongoing project

  • Start date

    1 April 2016

  • End date

    31 March 2021

Funded under:

H2020-EU.3.1.

  • Overall budget:

    € 15 430 660

  • EU contribution

    € 8 553 750

Coordinated by:

SCLAVO VACCINES ASSOCIATION

Italy