A phase I clinical trial of a novel HIV vaccine designed to elicit a robust immune response has begun in several African countries. The trial aims to assess the safety and efficacy of T-cell-stimulated immunization against HIV-1.
The IAVI C114 clinical trial is being conducted at three clinical sites: the Mutala Trust Clinical Trials Center in Harare, Zimbabwe; the Desmond Tutu Health Foundation (DTHF) in Cape Town, South Africa; and the Africa Health Research Institute (AHRI) in Durban, South Africa. To determine the potential for a vaccine candidate to be effective in sub-Saharan Africa, where the burden of disease is highest, it is important that the candidate vaccine is tested in communities affected by the epidemic.
The Phase 1 clinical trial, the first in humans, will enroll approximately 120 healthy adults aged 18 to 50 years, including 48 people living with HIV and virally suppressed on antiretroviral therapy (ART). The randomized, blinded, dose-ranging study is designed to evaluate the safety and immunogenicity of the vaccine candidate in people living with and without HIV. Participants will receive one or two doses of the study vaccine or a placebo and will be followed for 19 months for safety and immune response.
In the trial, researchers will test how well the vaccine activates a specific T-cell immune response in healthy adult volunteers who are not infected with HIV. Positive results could pave the way for new approaches to HIV prevention, complementing current approaches, including the development of antibodies that neutralize a broad range of virus variants.
The vaccine candidate uses Moderna’s innovative mRNA-based platform. It encodes highly networked T-cell epitopes that are present in most strains of HIV-1. This strategy is expected to allow the immune system to recognize and attack key vulnerable parts of the virus.
The study is being conducted by the Mutala Trust, ReiThera Srl (ReiThera), the Ragon Institute at MIT, with support from the non-profit scientific organization IAVI in partnership with the Center for the AIDS Programme of Research in South Africa (CAPRISA).
“We are extremely pleased to launch this first phase of trials, which is the result of a successful global partnership,” said Stefano Colloca, CEO and co-founder of ReiThera. “This HIV vaccine candidate, developed on our GRAd platform, has great promise for eliciting a strong CD8 response targeting vulnerable viral sites.”
As a reminder, scientists have come closer to new possibilities for controlling HIV without continuous antiretroviral therapy (ART). The combination of two broadly neutralizing antibodies (bnAbs) with the immunomodulatory drug N-803 (Anktiva) helped most participants in a clinical trial avoid a rebound in viral load for a long time after stopping treatment. These results were presented at the 13th International Conference on HIV Science (IAS 2025). The study reinforces hope for new ways to control HIV without daily medication – something that millions of people with HIV around the world have been waiting for for years.