Online Reporter
Catherine Murombedzi
Health Correspondent
The Mutala Trust of Zimbabwe, the Ragon Institute of Mass General Brigham, MIT, ReiThera of Italy and IAVI, an American non-profit scientific organisation dedicated to developing vaccines and antibodies to prevent HIV and other infectious diseases, have announced the launch of a Phase 1 clinical trial for a novel HIV vaccine candidate, the Gorilla Adenovirus Vectored HIV Networked Epitopes Vaccine (GRAdHIVNE1).
The first doses were administered on July 28, 2025, at the Mutala Trust clinical trial site in Harare. The trial, known as IAVI C114, is enrolling approximately 120 healthy adults aged 18 to 50, including 48 people on antiretroviral therapy and are virally suppressed.
This global collaboration aims to assess the safety and immunogenicity of the vaccine in people living with and without HIV.
Key partners:
IAVI: A global non-profit scientific
organisation sponsoring the trial and developing vaccines and antibodies to
prevent HIV and other infectious diseases.
ReiThera: An Italian CDMO that developed the
GRAd viral vector platform and manufactured the vaccine candidate.
The Ragon Institute: Contributed to vaccine
design and immunogen development.
The Mutala Trust: A clinical trial site in
Harare, Zimbabwe, and founding member of Africa Clinical Research Network
(ACRN).
Where is the trial taking place?
The IAVI C114 clinical trial is taking place at three clinical trial sites, that is:
Mutala Trust Clinical Trial Site in Harare, Zimbabwe;
Desmond Tutu Health Foundation (DTHF), in Cape Town, South Africa;
Africa Health Research Institute (AHRI) in Durban, South Africa
What’s the goal?
This trial aims to evaluate the safety and effectiveness of the GRAdHIVNE1 vaccine candidate in preventing HIV infection. The collaboration brings together experts from around the world to develop a potential solution to the HIV epidemic.
Trial details:
- Vaccine Candidate: GRAdHIVNE1 uses a Gorilla
Adenovirus Vectored HIV Networked Epitopes Vaccine approach.
Trial Design: Phase 1, first-in-human clinical trial.
Number of Participants: Approximately 120 healthy adults aged 18-50 years.
Participant Groups:
– 48 people living with HIV who are virally suppressed on antiretroviral therapy (ART).
– 72 people with no HIV.
- Methodology:
– Random controlled trial.
– Participants will receive either one or two doses of the investigational vaccine or a placebo.
The trial will be monitored for safety and immune responses over a period of 19 months.
Age groups:
18-50 years: The trial will enroll healthy adults within this age range.
Selection:
Inclusion criteria: Healthy adults aged 18-50 years, including people living with HIV who are on ART and virally suppressed.
Funding:
The clinical programme is funded by the Gates Foundation.
This trial is an important step towards finding a potential solution to the HIV epidemic, which is set to be a generalised condition by 2030.
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Online Reporter