A New, Promising mRNA HIV Vaccine Based on COVID mRNA Technology to Start Phase 1 Clinical Trial

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A new clinical trial testing an experimental mRNA-based HIV vaccine has begun in South Africa, offering fresh momentum in the global effort to prevent HIV infection.

The Phase 1 study, known as IAVI G004, started on December 15, 2025, at the Perinatal HIV Research Unit in Soweto. The trial is evaluating novel vaccine candidates designed to help the immune system produce broadly neutralising antibodies, which can protect against many different strains of HIV.

More than 40 million people worldwide are living with HIV, and over one million new infections occur each year. Despite decades of research, no preventive HIV vaccine has yet been approved, making new approaches urgently needed.

The IAVI G004 trial builds on encouraging results from earlier studies and tests three mRNA-based immunogens developed by the International AIDS Vaccine Initiative (IAVI) and Scripps Research. These vaccine components are delivered using Moderna’s mRNA platform, the same technology used in several COVID-19 vaccines.

IAVI President and Chief Executive Officer Dr Mark Feinberg said the launch of the trial represents a major step forward, describing the strategy as one of the most promising paths toward an effective HIV vaccine.

“It is very exciting to see the launch of the IAVI G004 clinical trial,” said Mark Feinberg, M.D., Ph.D., President and CEO of IAVI, in a press release on January 6, 2026.

Funding for the study is provided by the Bill & Melinda Gates Foundation, with vaccine materials manufactured by Moderna and additional support from the Government of the Netherlands.

While no HIV vaccine has been approved by the US Food and Drug Administration, scientists continue to explore both preventive and therapeutic vaccine strategies. Therapeutic HIV vaccines, which aim to control the virus without daily antiretroviral therapy, are currently available only through clinical trials.

Health authorities stress that ongoing research into vaccines and new treatments remains critical to reducing HIV transmission and improving long-term outcomes for people living with HIV.

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