Description

Different approaches regarding the association between the microbiome and immune system response will be investigated, as follows:

• Novel methodologies as well as new biomarkers and biomarker combinations discovered during the project will be validated by the EMA through qualification of novel methodology procedures.
• The opinion of the CHMP will be obtained regarding the acceptability of specific uses of novel biomarkers, such as gut microbiome correlation with the following: (1) protection from HIV acquisition (WP1), (2) response to therapeutic HIV vaccines (WP2 and WP3), (3) cardiovascular and AIDS/non AIDS events (WP5), and (4) genotypic predictions of phenotypic antimicrobial drug resistance (WP5).
• Regulatory advice will be obtained regarding iVIHome (an integrated, comprehensive and freely accessible repository of all HIV microbiome data and metadata generated during the MISTRAL project) and regarding standard operating procedures, study protocols and bioinformatic codes used for analyses within the MISTRAL project. MISTRAL will work with the EU to ensure that iVIHome is connected to the future European Open Science Cloud (EOSC) initiative, so as to optimize the sharing and re-use of resources and cross-disciplinary interoperability with other data and tools.
• Close collaboration will be ensured with regulatory agencies regarding clinical evaluation of innovative immunotherapies in ongoing randomized clinical trials (WP3, WP6). Ongoing clinical trials have already been approved by the corresponding regulatory authorities. For the WP2 therapeutic vaccine clinical trial, formal scientific advice will be sought at the end of the project to discuss the outcome of the trial (WP2) and the long-term regulatory pathway.

Objectives

To provide regulatory support and advice during the execution of the MISTRAL project, taking into account legal and regulatory considerations affecting treatment for HIV infection.