Funded by Global Health EDCTP3 and the European Union, the project brings together 21 partners across Africa, Europe and the United States to improve early HIV treatment outcomes in infants.
The international research project ENABLE – Early Neutralizing Antibodies in Infants Living with HIV to Enhance their Life – officially launched on 1st of January 2026. Funded by Global Health EDCTP3 and the European Union (GA 101190620), the four-year project brings together 21 leading research institutions from Africa, Europe and the United States, coordinated by the Servicio Madrileño de Salud (SERMAS, Madrid, Spain) and represented by Hospital Universitario 12 de Octubre, with Penta leading the Ethics and Regulatory work.
ENABLE will investigate whether broadly neutralizing antibodies (bNAbs) added to antiretrovirals can help achieve earlier viral control in infants diagnosed with HIV. Despite progress in HIV care, major gaps remain: in Africa, only about half of infants born with HIV receive early antiretroviral therapy, and more than 10% die within the first year after diagnosis, even when antiretroviral treatment is started early. Viral suppression remains a major challenge, with only 25–50% of infants reaching undetectable viral levels in routine care.
Through the clinical trial led in South Africa, Mozambique and Cameroon, the project will evaluate whether administering two broadly neutralizing antibodies (bNAbs) alongside standard antiretroviral therapy can improve viral suppression in infants. The project will also evaluate patients’ markers, especially related to remission/cure biomarkers—such as immune responses, viral reservoir, and biological molecule levels—to identify factors linked to better protection, while also studying how long antibodies stay in the body and what levels are needed for effective treatment. Engagement with communities, caregivers, and healthcare providers will be conducted to assess how acceptable bNAb-based treatments for children would be and to identify factors that could affect their future adoption.
Through our focus on regulatory and ethics issues, Penta will play a key role in supporting the development and implementation of the overall regulatory study strategy. This will include coordinating and preparing all necessary documentation for submissions to regulatory authorities and ethics committees, ensuring that all materials meet the required standards and timelines. Furthermore, Penta will contribute to guaranteeing that the study is conducted in accordance with ethical principles and fully complies with all applicable regulations and guidelines throughout its entire duration.
The ENABLE consortium held its kick-off meeting on 3–4 February 2026 in Cape Town, marking the start of a collaborative effort to advance innovative treatment strategies for infants living with HIV.
The project is supported by the Global Health EDCTP3 and its members under the Grant Agreement 101190620. Co-funded by the European Union.