Moderna and non-profit scientific research organisation IAVI are set to commence Phase I IAVI G003 clinical trial of a messenger ribonucleic acid (mRNA) human immunodeficiency virus (HIV) vaccine antigen, mRNA-1644, in Rwanda and South Africa.
The first subject screenings for the trial will be initiated at the Center for Family Health Research (CFHR) in Kigali, Rwanda and The Aurum Institute in Tembisa, South Africa.
Sponsored by IAVI, the trial builds on advances in HIV vaccine research.
It will analyse if inoculation with HIV immunogen eOD-GT8 60mer offered through the mRNA platform of Moderna can elicit immune responses in African populations.
Scientific teams at IAVI and Scripps Research developed eOD-GT8 60mer.
It is created to be part of a multi-step inculcation regimen that will induce an immune response to stimulate broadly neutralising antibodies (bnAbs) that neutralise or hinder HIV infection.
A total of 18 healthy HIV-negative adult subjects will be enrolled in the trial.
All subjects will be given two doses of eOD-GT8 60mer mRNA, which comprises a viral sequence portion and cannot cause HIV infection.
Subjects will be observed for safety for six months following the administration of the last dose and their immune responses will be evaluated in molecular detail to assess if the desired responses are attained.
This open-label trial will have no blinding and randomisation with all subjects receiving the intervention.
Safety and immunogenicity are the primary endpoints of the trial.
Moderna CEO Stéphane Bancel said: “With our mRNA technology and IAVI’s discovery and development expertise, we are looking forward to advancing a novel approach to overcome some of the longstanding hurdles to developing a protective HIV vaccine.”
According to the data from a Phase I IAVI G001 trial, inoculation with eOD-GT8 60mer as a recombinant protein was demonstrated to safely elicit the targeted immune responses in 97% of healthy adult subjects in the US.
In March this year, the company doses first subject in a Phase I HVTN 302 trial of an investigational HIV trimer mRNA vaccine, mRNA-1574.