The project

VIROMARKERS is supported by the Innovative Health Initiative Joint Undertaking (IHI JU) under grant agreement No 101194735. The JU receives support from the European Union’s Horizon Europe research and innovation programme and COCIR, EFPIA, Europa Bio, MedTech Europe, Vaccines Europe, and Roboscreen.

Start date
1 February 2025

End date
31 January 2028

Grant ID
101194735

Total grant amount
€ 4 358 845,00

of which, EU contribution
€ 2 329 503,75

of which, industries’ contribution
€ 2 029 341,25

Project Structure

VIROMARKERS is divided into 3 research oriented and 3 support work packages (WPs) all interrelated.

WP1:

Validating biomarkers of susceptibility to broadly neutralising HIV-1 antibodies (bNAbs).

WP2:

Validating HDV-related biomarkers for treatment response, in specific bulevirtide treatment. WP2 includes 1 clinical trial.

WP3:

Validating viral quantification as a diagnostic biomarker in immunocompromised patients. WP3 includes 2 clinical trials.

WP4:

Ensures compliance with ethical requirements.

WP5:

Responsible for the communication, dissemination, and exploitation of the project activities and results.

WP6:

Ensures proper management and coordination of the project and consortium.

Objectives

01

To demonstrate a novel bioinformatics method for prediction of HIV-1 susceptibility to broadly neutralising antibodies based on the HIV-1 gp120 sequence.

02

To demonstrate novel HBV biomarkers (HDV-RNA, HBsAg isoforms and HDV genotype) to predict treatment response to the recently approved anti-HDV bulevirtide.

03

To validate serum CMV-RNA as a biomarker of CMV infection/reactivation to optimise the correct timing for preventive strategies in patients undergoing hematopoietic stem cell transplantation.

04

To validate the torque teno virus DNA as a prognostic biomarker for CMV disease in immunocompromised patients.

05

To validate total and intact cellular HIV DNA as a biomarker of HIV infection status to guide novel antiviral strategies. Validation or demonstration of several technologies required to measure the candidate biomarkers is an integral part of the project objectives. In particular, this refers to the following diagnostic tools:

  1. qPCR as a tool for HDV quantification

  2. NGS platform for HIV and HDV sequencing

  3. qPCR diagnostics for CMV-RNA quantification

  4. IPDA suitable for detection of intact HIV-DNA in any viral subtype

  5. qPCR diagnostics for TTV-DNA