The first doses of a promising investigational HIV vaccine candidate, known as GRAdHIVNE1 (Gorilla Adenovirus Vectored HIV Networked Epitopes Vaccine), have been administered as part of a landmark Phase 1 clinical trial. The vaccine was first given on July 28, 2025, at the Mutala Trust clinical trial site in Harare, Zimbabwe. This initiative represents a collaborative global effort involving African leadership, with principal investigators in Zimbabwe and South Africa guiding the trial. The trial aims to generate data on the vaccine’s safety and immune response, particularly its ability to induce T cell-based immunity against HIV.
The Phase 1 clinical trial, called IAVI C114, will involve approximately 120 healthy adults aged 18–50, including 48 people living with HIV who are currently virally suppressed on antiretroviral therapy. Participants will receive one or two doses of either the vaccine or a placebo. Over a 19-month period, the trial will monitor safety and immunogenicity, especially the vaccine’s ability to stimulate CD8+ T cell responses against critical HIV regions.
IAVI is sponsoring the trial, with funding from the Bill & Melinda Gates Foundation. ReiThera developed the GRAd vector technology and produced the vaccine candidate, while the Ragon Institute of Mass General Brigham, MIT, and Harvard designed the immunogen using insights gained from studying elite controllers of HIV. Clinical sites include the Mutala Trust in Harare, Desmond Tutu Health Foundation in Cape Town, and Africa Health Research Institute in Durban, supported by top-tier African laboratories for immunological analysis.
This trial is seen as a major milestone for Africa and the global HIV research community. Leaders involved have emphasized the significance of African-led research and community-based testing, which ensures the vaccine candidate is evaluated where it is most needed. The GRAdHIVNE1 vaccine is designed to guide the immune system, particularly CD8+ T cells, to recognize and target HIV-infected cells by focusing on stable structural regions of the virus that are less likely to mutate.
Researchers and developers involved in the project expressed hope that this vaccine could serve as the foundation for future therapeutic or curative approaches. They highlighted the powerful collaboration that made the trial possible—blending scientific innovation, African leadership, and strategic global partnerships to bring the world closer to an effective HIV vaccine.
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