8 August 2025 – Harare, Zimbabwe / Cape Town & Durban, South Africa – African clinical research institutions, in partnership with global collaborators, have launched a Phase 1 clinical trial to evaluate a novel HIV vaccine candidate, GRAdHIVNE1. The trial is being conducted by Mutala Trust (Zimbabwe), the Desmond Tutu Health Foundation (DTHF), and the Africa Health Research Institute (AHRI), with IAVI as the study sponsor, and funded by the Gates Foundation.

The GRAdHIVNE1 vaccine candidate is designed to generate strong immune responses through a novel approach that uses a non-replicating gorilla adenovirus vector to deliver HIV-specific components to the immune system.

The trial, known as IAVI C114, reflects the growing role of African investigators, institutions, and communities in advancing vaccine science and global health interventions. It brings together clinical, laboratory, and community engagement expertise across Southern Africa in partnership with international developers and sponsors.

“This study reflects the growing capabilities of African research institutions to conduct ethical, high-quality clinical research. Strengthening African leadership in vaccine development ensures that innovations are responsive to local contexts and health priorities,” said Dr. Tariro Makadzange, Principal Investigator, Mutala Trust.

About the Study

The IAVI C114 trial will enroll approximately 120 healthy adults aged 18–50 years, including 48 people living with HIV who are virally suppressed on antiretroviral therapy (ART). The study is randomized, placebo-controlled, and double-blinded, and participants will be followed for 19 months to assess the safety and immune responses generated by the vaccine candidate.

The study sites include:

• Mutala Trust, Harare, Zimbabwe
• Desmond Tutu Health Foundation (DTHF), Cape Town, South Africa
• Africa Health Research Institute (AHRI), Durban, South Africa

Scientific endpoints of the study will be led by African laboratories and researchers:

• Cape Town HVTN Immunology Laboratory (CHIL), Cape Town, South Africa
• National Institute for Communicable Diseases (NICD), Johannesburg, South Africa

Global Collaboration and Scientific Innovation

The trial is conducted in collaboration with global scientific partners:

• ReiThera (Italy) developed the vector platform and manufactured the vaccine.
• The Ragon Institute of MGH, MIT and Harvard (USA) contributed to immunogen design based on targeting conserved HIV epitopes.
• IAVI is the trial sponsor and supports overall trial implementation and execution in close partnership with the study sites.

This study is made possible through collaboration with multiple partners committed to equitable vaccine development.

“This trial represents the future of vaccine development, rooted in Africa, built through global partnerships, and designed for the communities most affected by HIV,” said Dr. Vincent Muturi-Kioi, HIV Vaccines Product Development Lead, IAVI.

About the Collaborating Institutions

• Mutala Trust is founding member of Africa Clinical Research Network (ACRN) and is a site based in Harare, Zimbabwe. It is known for conducting high-quality, ethically sound clinical trials addressing diseases that affect African communities. Mutala is the clinical lead site for the study..
• Desmond Tutu Health Foundation (South Africa) is a pioneer in community-based HIV prevention and treatment research, with a strong track record in clinical trials.
• Africa Health Research Institute (South Africa) combines population studies, clinical trials, and lab science to inform health solutions in South Africa and beyond.
• Cape Town HVTN Immunology Laboratory (South Africa) specialized laboratory for the analysis of immune responses to candidate vaccines.
• National Institute for Communicable Diseases (South Africa) is South Africa reference center for surveillance, diagnostics and research on infectious diseases providing advanced laboratory support vaccine trials.
• IAVI is a global nonprofit scientific research organization developing vaccines and antibodies for HIV, tuberculosis, and emerging infectious diseases.
• ReiThera is an Italian biotech company with expertise in viral vector vaccine production.
• The Ragon Institute of MGH, MIT, and Harvard is a leader in immunology and virology research focused on understanding immune protection and guiding vaccine design.