VSV-EBOPLUS · Project

Immune Signature Data to Speed Up Ebola Vaccine Licensing and Pediatric Use

healthTestedTRL 4Thin data (2/5)

Imagine you have a promising Ebola vaccine that saved lives during an outbreak, but you still don't know exactly why it works, how long protection lasts, or whether it's safe for children. This project took blood samples from almost 1,000 vaccinated people — adults, teenagers, and kids — across three continents and used advanced biological analysis to decode the body's immune response at the molecular level. Think of it like reverse-engineering the vaccine's instruction manual so regulators and manufacturers know exactly what to expect. The goal was to fill the evidence gaps that stand between a promising emergency vaccine and a fully licensed product.

By the numbers

~1,000

Vaccinated subjects analyzed (adults, adolescents, children)

512

Adults injected with graded vaccine doses for early immune response analysis

Countries across three continents contributing clinical data

EUR 8,553,750

Total EU contribution to the project

Consortium partners including 2 industry players

Total project deliverables produced

The business problem

What needed solving

Ebola vaccines like VSV-ZEBOV showed strong results during emergency use, but critical questions about their mode of action, duration of protection, pediatric safety, and dose optimization remained unanswered after the 2014-2015 outbreak ended. Without this evidence, regulators cannot fully license the vaccine, manufacturers cannot optimize production doses, and public health agencies cannot plan pediatric vaccination campaigns — leaving populations vulnerable to future outbreaks.

The solution

What was built

The project produced immune and molecular signature profiles from clinical trial samples of almost 1,000 subjects (adults, adolescents, children) vaccinated with graded doses of VSV-ZEBOV across 8 countries. Deliverables include systems biology analyses of early immune responses, correlates of protection data, and harmonized multi-continent clinical trial protocols.

Audience

Who needs this

Vaccine manufacturers pursuing Ebola or viral vector vaccine regulatory approvalDiagnostic companies developing immune response biomarker assaysContract research organizations designing trials for outbreak vaccinesPublic health agencies planning Ebola vaccination campaigns in endemic regionsPharmaceutical companies using viral vector platforms for other diseases

Business applications

Who can put this to work

Pharmaceutical & Vaccine Manufacturing

enterprise

Target: Vaccine manufacturers seeking regulatory approval for Ebola or viral vector-based vaccines

If you are a vaccine manufacturer trying to get your Ebola or vector-based vaccine licensed — this project generated immune and molecular signature data from 512 adults across graded doses, plus pediatric cohorts, giving you the biomarker evidence regulators demand for licensure. The systems biology dataset from almost 1,000 subjects across three continents can de-risk your regulatory filing.

Diagnostics & Biomarker Development

mid-size

Target: Diagnostic companies developing immune response assays or companion diagnostics for vaccines

If you are a diagnostics company looking to develop assays that predict vaccine efficacy or identify non-responders — this project mapped the early immune signatures (days 0 to 7) and long-term correlates of protection for VSV-ZEBOV. These validated biomarker profiles can form the basis for companion diagnostic kits used in vaccination campaigns.

Contract Research & Clinical Trials

mid-size

Target: CROs running vaccine trials in Africa or for emerging infectious diseases

If you are a contract research organization running vaccine trials in multiple countries — this project developed harmonized and standardized clinical trial protocols tested across 8 countries including Gabon and Brazil. The methodology for systems vaccinology analysis in resource-limited settings can strengthen your trial design for future outbreak vaccines.

Frequently asked

Quick answers

What would it cost to access this immune signature data?

The project was publicly funded with EUR 8,553,750 under IMI2 (Innovative Medicines Initiative), meaning core research outputs should be accessible through publication and data-sharing agreements. Licensing terms for proprietary datasets or tools would need to be negotiated directly with the coordinator, Sclavo Vaccines Association in Italy.

Can these findings be applied at industrial scale for vaccine production?

The immune signatures and biomarker data were generated from almost 1,000 subjects across clinical trials on three continents, which is a substantial evidence base. However, this project focused on understanding the vaccine's mechanism — not on manufacturing scale-up. The data supports regulatory filings and dose optimization rather than production processes.

Who owns the intellectual property from this project?

As an IMI2 project, IP is typically shared between the academic and industry partners according to the consortium agreement. With 2 industry partners and 11 total consortium members across 8 countries, licensing would likely require agreement from multiple parties. Contact the coordinator for specific IP arrangements.

Is this vaccine already approved by regulators?

The VSV-ZEBOV vaccine demonstrated high protective efficacy in the WHO-sponsored ring-vaccination trial in Guinea during the 2014-2015 outbreak. This project aimed to fill remaining evidence gaps — mode of action, duration of protection, pediatric efficacy — that are central to future licensing. Based on available project data, the regulatory status would need to be verified with current EMA/FDA records.

How long did the project run and what stage are the results at?

The project ran for 7 years, from April 2016 to March 2023. It produced 7 deliverables including systems biology analyses of immune responses. The results are research-grade evidence suitable for supporting regulatory submissions, not a market-ready product themselves.

Can the systems biology approach be reused for other vaccines?

Yes, the harmonized clinical trial protocols and transcriptomics analysis pipeline developed for VSV-ZEBOV can be applied to other viral vector vaccines or emerging infectious disease candidates. The methodology for analyzing early immune responses (days 0 to 7) across diverse populations is transferable to other vaccine platforms.

Consortium

Who built it

The VSV-EBOPLUS consortium brings together 11 partners from 8 countries spanning three continents — including Brazil and Gabon alongside European and US institutions. With 6 universities, 2 research organizations, and 2 industry partners (18% industry ratio), this is a research-heavy consortium led by Italy's Sclavo Vaccines Association. The geographic spread reflects the global nature of Ebola preparedness, with African and South American partners providing access to endemic populations. The presence of 1 SME and 2 industry players suggests some commercial interest, but the consortium's strength lies in its clinical trial network and academic depth rather than immediate commercialization capacity.

SCLAVO VACCINES ASSOCIATIONCoordinator · IT
ACADEMISCH ZIEKENHUIS LEIDENparticipant · NL
UNIVERSITA DEGLI STUDI DI SIENAparticipant · IT
MICROBIOTEC SRLparticipant · IT
UNIVERSITE DE GENEVEparticipant · CH
MERCK SHARP & DOHME CORPparticipant · US
EIDGENOSSISCHES DEPARTEMENT FUR VERTEIDIGUNG, BEVOLKERUNGSSCHUTZ UND SPORTparticipant · CH
EBERHARD KARLS UNIVERSITAET TUEBINGENparticipant · DE
Centre de Recherches Medicales de Lambarénéparticipant · GA
GOETEBORGS UNIVERSITETparticipant · SE
UNIVERSIDADE DE SAO PAULOparticipant · BR

How to reach the team

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Next steps

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