Buoyed by the results of its trials in the U.S., Moderna Inc. announced that it had launched a Phase I clinical trial in Africa, the first of its kind, for its HIV vaccine that is currently in development, a press release said.
Cambridge, Massachusetts, based Moderna shot to fame when it developed a vaccine against COVID-19 at the pandemic's beginning. The company's rapid response came primarily due to the mRNA technology. Moderna's tech could be rapidly scaled and quickly modified compared to conventional vaccine manufacturing processes if the virus mutated in a very different variant.
The company is now focusing its strengths on developing other vaccines that had taken a backseat during the pandemic.
An mRNA vaccine to tackle HIV
Earlier this year, Moderna launched the first human trial of its HIV vaccine in the U.S in which it used eOD-GT8 60mer, a part of the HIV RNA sequence, as a recombinant protein. Designed by researchers at Scripps Research Institute, the immunogen elicits a specific type of B cell which then leads to the development of broadly neutralizing antibodies (bnAbs) which are considered an important goal of an effective HIV vaccine. In the U.S. trial, the vaccine was determined to be safe and evoked an immune response in 97 percent of the trial participants (healthy adults), the press release said.
The Phase I trial in Africa is funded by the International AIDS Vaccine Initiative (IAVI) and aims to replicate the findings of the U.S. trial in the African population. Called IAVI G003, the trial will enroll a total of 18 healthy and HIV-negative adults who will go on to receive two doses of the eOD-GT8 60mer mRNA, which contains a part of the viral sequence but cannot cause the infection.
This will be an open-label trial with no randomization which means that all participants will receive the vaccine. They will then be monitored for a period of six months to determine that the vaccine is safe while their immune response will be studied in detail at a molecular level to confirm that the targeted response is achieved. The endpoints of the trial will be confirmed by the researchers working at various medical institutes in Kenya, the press release said.
"We are grateful for the opportunity to work in partnership with researchers and scientists from communities heavily burdened by HIV, said Stéphane Bancel, CEO of Moderna. "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. Moderna's HIV vaccine development program, together with our portfolio of COVID-19, Zika, and Nipah programs, advances 4 of the 15 priority vaccine programs we committed to develop by 2025, targeting infectious diseases that threaten global health."