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SOWETO, South Africa – December 16, 2025 – The first doses of an experimental HIV vaccine were administered on December 15, 2025, at the Perinatal HIV Research Unit in Soweto, South africa, marking a pivotal moment in the decades-long quest for a preventative HIV vaccine. With over 40 million people currently living with HIV and more than a million new infections each year, the need for innovative prevention strategies has never been more critical.
A Novel Approach to HIV Vaccine Development
Scientists are testing whether a carefully sequenced vaccine can “coach” the immune system to create antibodies capable of neutralizing many strains of HIV.
- The phase 1 IAVI G004 clinical trial began with vaccinations in 96 healthy adults.
- The study utilizes mRNA technology from Moderna to deliver three experimental immunogens.
- Researchers aim to identify the lowest effective dose while minimizing side effects.
- This trial builds on promising results from earlier IAVI G001,G002,and G003 studies.
What makes this vaccine different? Unlike previous attempts, this strategy focuses on prompting the body to produce broadly neutralizing antibodies (bnAbs)-antibodies that can attack a wide range of HIV variants. The IAVI G004 clinical trial is designed to test whether a specific sequence of vaccine immunogens can effectively target B cells within the immune system, guiding them to generate these crucial bnAbs.
Building on Previous successes
The IAVI G004 trial is a Phase 1 study, meaning its primary goal is to assess safety and determine appropriate dosage levels. Ninety-six healthy, HIV-negative adult participants will be enrolled across six clinical sites in South Africa.Researchers are evaluating the immunogens.
“Whilst ther have been wonderful breakthroughs in pre-exposure prophylaxis in recent years, the need for a safe and effective vaccine to eliminate HIV infection remains as urgent as ever,” said Linda-Gail Bekker, MBChB, DTMH, DCH, FCP (SA), Ph.D., CEO of the Desmond Tutu Health Foundation and a principal investigator for the study. “The commencement of this vital trial in South Africa, where that need is so great, moves us closer to the goal of ending HIV for everyone everywhere.”
Funding for the trial comes from the Gates Foundation through the collaboration for AIDS Vaccine Discovery (CAVD), with clinical trial materials funded by the Scripps Research Center for HIV/AIDS Vaccine Development (CHAVD). Moderna manufactured the clinical trial materials. The vaccine candidate was developed by IAVI and Scripps Research scientists with funding from the Gates Foundation to the IAVI Neutralizing Antibody Center (NAC), with additional support from the government of the Netherlands.
“We are excited to evaluate these mRNA immunogens at lower doses, including two immunogens previously tested at higher doses and the first-in-human test of our N332-GT5 membrane-bound trimer aiming to prime a new type of bnAb,” explained William Schief, Ph.D., professor at Scripps research.