Building on the results of its trials in the United States, Moderna Inc. announced that it had launched a phase I clinical trial in Africa, the first of its kind, for its HIV vaccine currently in development, a press release says. .
Moderna, based in Cambridge, Massachusetts, rose to fame when it developed a vaccine for COVID-19 early in the pandemic. The company’s rapid response is mainly due to mRNA technology. Moderna’s technology could be quickly scaled up and quickly changed from conventional vaccine manufacturing processes if the virus mutated into a very different variant.
The company is now focusing its forces on the development of other vaccines that had taken precedence during the pandemic.
An mRNA vaccine to fight HIV
Earlier this year, Moderna launched the first human trial of its HIV vaccine in the United States in which it used eOD-GT8 60mer, part of the HIV RNA sequence, as a recombinant protein. Designed by researchers at the Scripps Research Institute, the immunogen induces a specific type of B cell which then leads to the development of broadly neutralizing antibodies (bnAbs) which are considered an important target of an effective HIV vaccine. In the US trial, the vaccine was found to be safe and elicited an immune response in 97% of trial participants (healthy adults), according to the press release.
The phase I trial in Africa is funded by the International AIDS Vaccine Initiative (IAVI) and aims to replicate the results of the US trial in the African population. Called IAVI G003, the trial will enroll a total of 18 healthy, HIV-negative adults who will then receive two doses of the eOD-GT8 60mer mRNA, which contains part of the viral sequence but cannot cause infection.
This will be an open-label trial without 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 the molecular level to confirm that the targeted response is being achieved. The endpoints of the trial will be confirmed by the researchers working at various medical institutes in Kenya, according to the press release.
“We are grateful to have the opportunity to partner with researchers and scientists from communities heavily impacted by HIV,” said Stephane Bancel, CEO of Moderna. “With our mRNA technology and IAVI’s expertise in discovery and development, we look forward to advancing an approach to overcome some of the long-standing barriers to developing a protective HIV vaccine.” . Moderna’s HIV vaccine development program, along with our portfolio of COVID-19, Zika and Nipah programs, is advancing 4 of the 15 priority vaccine programs we have committed to developing by 2025, targeting diseases infections that threaten global health. »
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