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EARLY NEUTRALIZING ANTIBODIES IN INFANTS LIVING WITH HIV TO ENHANCE THEIR LIFE

Objective

Early ARV treatment in sub-Saharan Africa (SSA) reaches only approximately 50% of infants born with HIV. Mortality in infants in the first 12 months after diagnosis is still over 10% in early treated infants diagnosed at birth, 25% in infants diagnosed with opportunistic infections. According to our experience, the probability of virological control 1 year after diagnosis is only 25 to 35%, even after the rollout of dolutegravir (DTG).
As a solution for this problem, we propose the addition of four shots of subcutaneous (SC), long-half-life broadly neutralizing antibodies (bNAbs) at diagnosis, and 3, 6 and 9 months after diagnosis, as an add-on to standard oral ART will provide immediate therapeutic benefit and decrease HIV viral load levels in the most critical period of life of children with HIV, allowing for a decreased risk of co-infections, HIV-encephalopathy and death.
We will evaluate for the first time the efficacy of combining two bNAbs (ePGT121v1-LS and VRC07-523-LS, as intensification therapy for ART, to achieve viral suppression within one year after diagnosis in high risk-infants with HIV. The specific aims to achieve this general aim will be: to perform a phase II/III trial with bNAbs, capacity strengthening related with bNAbs in Africa, to characterize biomarkers for anticipating response to bNAbs, to identify the barriers and facilitators of rollout of bNAbs as a treatment, and to liaise with relevant stakeholders
The pathway to achieve this aim will be a collaborative framework between a scientific network with partners in several SSA countries, producers of bNAbs, and European and African laboratories.
With this approach, the probability of viral suppression 1 year after diagnosis will be increased from 30% to 95% to achieve 2030 UNAIDS 3rd target. This achievement will impact in a reduction of HIV- associated morbidity and mortality in the first year of life and beyond in more than 130 000 infants every year.

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Topic(s)

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HORIZON-JU-RIA - HORIZON JU Research and Innovation Actions

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Call for proposal

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(opens in new window) HORIZON-JU-GH-EDCTP3-2024-01-two-stage

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Coordinator

SERVICIO MADRILENO DE SALUD
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 146 250,00
Address
Paseo De la Castellana, 280
28046 MADRID
Spain

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Region
Comunidad de Madrid Comunidad de Madrid Madrid
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 1 284 391,25

Participants (18)

Partners (2)

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