IAVI Launches Phase 1 HIV Vaccine Trial in South Africa

NEW YORK,NY – January 6,2026 – IAVI,a global nonprofit scientific research organization,announced the initiation of the IAVI G004 clinical trial on December 15,2025,at the Perinatal HIV Research Unit in Soweto,South africa. This marks a important step forward in the progress of an HIV vaccine, utilizing a novel strategy to elicit broadly neutralizing antibodies (bnAbs) IAVI G004.

The Quest for an HIV vaccine

Despite significant advancements in HIV prevention and treatment, including pre-exposure prophylaxis (PrEP), a safe and effective HIV vaccine remains a critical public health goal. As of 2024, approximately 40.8 million people globally were living with HIV, and 1.3 million new infections occurred UNAIDS. An effective vaccine is considered essential for sustainably controlling and ultimately ending the AIDS pandemic.

IAVI’s Innovative Approach: Coaching the Immune System

The IAVI/Scripps research strategy focuses on “coaching” the immune system to produce bnAbs, antibodies capable of neutralizing a wide range of HIV strains. This approach differs from traditional vaccine strategies and has shown promising results in earlier trials. The IAVI G004 trial builds upon the encouraging data from the IAVI G001, G002, and G003 clinical trials, which demonstrated a pathway to generate these crucial bnAbs.

The IAVI G004 Trial: Design and Objectives

This Phase 1 trial is designed to evaluate the safety, immune responses, and optimal dosage of three HIV immunogens delivered via Moderna’s mRNA platform.The immunogens – eOD-GT8 60mer, Core-g28v2 60mer, and N332-GT5 gp151 – were developed at Scripps Research scripps research. The study will enroll 96 healthy, HIV-uninfected adult participants at six clinical sites across South Africa:

• Desmond tutu Health Foundation (DTHF) Emavundleni and Groote Schuur Hospital Clinical Research Sites (J52) in Cape Town
• eThekwini CAPRISA Research Clinic in Durban
• South African Medical research Council (SAMRC) Isipingo Clinical Research Center in Isipingo Rail
• Setshaba research Center in Soshanguve
• Perinatal HIV Research Unit in Soweto

A dose escalation model will be used to identify the lowest dose that elicits an immune response while minimizing potential side effects, such as skin reactions observed in the previous IAVI G002 study.

expert Perspectives

“It is indeed very exciting to see the launch of the IAVI G004 clinical trial,” said IAVI President and CEO Mark Feinberg, M.D., Ph.D.”With this year’s global funding cuts to HIV prevention, care, and treatment, bringing new prevention tools forward is more important than ever. We believe we are on the most promising path ever pursued for the development of an effective vaccine against HIV.”

William Schief, Ph.D., professor at Scripps Research, added, “We are excited to evaluate these mRNA immunogens at lower doses… We are hoping this study will demonstrate safety and immunogenicity and lead to future studies that induce protective bnAbs.”

Linda-Gail Bekker, MBChB, DTMH, DCH, FCP (SA), Ph.D., CEO of the Desmond Tutu Health Foundation, emphasized, “The commencement of this critically important trial in South Africa… moves us closer to the goal of ending HIV for everyone everywhere.”

Funding and Collaboration

The clinical trial is funded by the Gates Foundation through the Collaboration for AIDS Vaccine Discovery (CAVD). Funding for the clinical trial materials is provided through 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).