2022 Rome Action Plan on Paediatric HIV & TB
IAVI commits to:
219. Pursue Phase 1 studies of a highly potent, novel bNAbs combination by 2024 to support demonstration of safety and enable subsequent evaluation for a postnatal prophylaxis (PNP) indication.
220. Advance research, advocacy, and contribute to collaboration and coordination designed to ensure more efficient and timely investigation of bNAbs in the context of PNP.
221. Ensure early engagement of communities and local stakeholders in Africa to define a regionally driven clinical development plan for a PNP indication for the bNAbs.
219. October 2023:
IAVI is on track to commence the Phase 1 study of a highly potent, novel bNAbs combination in 2024
220. October 2023:
Through the USAID/PEPFAR funded ADVANCE program, to foster collaboration and coordination in designing more efficient and timely clinical trials for the evaluation of bNAbs for postnatal prophylaxis, IAVIconvened a two-day consensus-building workshop in Cape Town, South Africa in Feb 2023 with more than 70 ethicists, community members, regulators, researchers, implementers, civil society, funders, and statisticians.
IAVI kicked off a Task Force in July 2023 to develop an Action Plan to carry forward and build upon key recommendations from the Cape Town meeting. More than 80 individuals from 44 organizations have joined the Task Force and are contributing to the development of the Action Plan.
221. October 2023:
IAVI launched a Community Engagement Working Group, consisting of ANC nurses, Community Liaison officers, mothers (PLP), and participants from previous bnAb trials from nine high transmission countries to support good participatory practice (GPP) for stakeholder engagement throughout the clinical development process to build trust within communities, ensure clear communication of trials, and to establish concurrence on the ethical aspects of the trial design.
In partnership with the CASPR coalition, IAVI leveraged the Research Literacy Learning Collaborative and other networks within Central, East, West and South Africa to organize a workshop series geared at engaging & strengthening capacity and literacy of interested civil society advocates on bNAbs, including for use in postnatal prophylaxis.