International AIDS Vaccine Initiative (IAVI) has commenced the Phase I IAVI G001 clinical trial to evaluate safety and immunogenicity of eOD-GT8 60mer vaccine for the treatment of HIV.
The trial aims to enrol 48 healthy adult subjects who will receive two doses of eOD-GT8 60mer along with AS01 adjuvant, developed by GSK, or placebo.
The study doses will be provided two months apart and will be administered through intramuscular injection.
Two sites in the US, including George Washington University (GW) in Washington DC, and Fred Hutchinson Cancer Research Center in Seattle, Washington, will conduct the trial.
The trial at GW will be led by GW Department of Medicine associate professor Dr David Diemert, while Fred Hutchinson Cancer Research Center Vaccine and Infectious Disease Division senior vice-president and director Dr Julie McElrath will lead the trial at this site.
Results from the trial are expected to be available late next year.
IAVI president and CEO Mark Feinberg said: “The world urgently needs new ways to prevent HIV infection, and chief among these is a vaccine.
“Fortunately, a new generation of HIV immunogen candidates, including eOD-GT8 60mer, is entering clinical trials.
“These candidates are being developed using highly sophisticated and elegant vaccine science and provide a precedent for vaccine strategies targeting the induction of specific immune responses believed to be critical in protecting against HIV infection.”
IAVI Scripps Research Neutralizing Antibody Center (NAC) vaccine design director Dr William Schief and his colleagues have developed eOD-GT8 60mer, which is designed to stimulate the immune system to start a key first step in the production of potent proteins, known as broadly neutralising antibodies (bNAbs).
Schief said: “In this trial, our goal is to prove that it is possible to induce responses from special, targeted B-cells.
“We’ll have a promising outcome if some of the vaccine recipients produce B-cells expressing a specific type of antibody, whereas placebo recipients do not.
“This would confirm that we are able to induce the desired initial immune response, and the next step will be making technical refinements to improve performance.”