[팜뉴스=이권구 기자] Moderna announced on the 18th that it has begun screening participants for the Phase 1 clinical trial of the mRNA HIV vaccine antigen (mRNA-1644) in South Africa and Rwanda with the non-profit scientific research group International AIDS Vaccine Initiative (IAVI).
This IAVI-sponsored clinical trial, IAVI G003, advances existing HIV vaccine research. In the G001 phase 1 clinical trial conducted recently by IAVI, it was found that recombinant proteinized HIV immunogen eOD-GT8 60mer was safely induced in 97% of recipients (healthy American adults) when vaccinated.
According to Moderna, IAVI G003 is capable of inducing an immune response similar to that shown in IAVI G001 when delivered to the human body via the Moderna mRNA platform, eOD-GT8 60mer vaccine developed by IAVI and Scripps Research. designed to test the hypothesis that
IAVI G003 was made possible with the support of the President’s Emergency Plan for AIDS (PEPFAR) through the United States Agency for International Development (USAID). Additionally, grants from the Bill & Melinda Gates Foundation to Moderna, The Collaboration for AIDS Vaccine Discovery (CAVD) and the Vaccine Immunology Statistical Center (VISC) were used.
Mark Feinberg, IAVI CEO, said: “The IAVI G003 represents Moderna’s proven mRNA vaccine technology, a novel HIV vaccine approach developed over the years by IAVI and Scripps Research, and the superiority of sub-Saharan Africa supported by USAID. “Based on more than 20 years of collaboration with the Scientific Center, we aim to advance scientist-led HIV vaccine development and research in the countries that need it most.”
Moderna CEO Stefan Bansel said, “Moderna aims to develop 15 vaccines against infectious diseases that threaten human health worldwide by 2025. Together with antivirus, it belongs to four leading development programs.”
According to Moderna, a total of 18 healthy HIV-negative adult participants are expected to be enrolled for IAVI G003 Phase 1, and all participants will receive two doses of eOD-GT8 60mer mRNA that contains some HIV virus sequences but does not cause HIV infection. receive
There is no double-blind and randomization in this open-label study, and all participants receive trial drug. Enrolled participants are monitored for safety for six months after receiving their last dose, and researchers examine the participants’ immune responses in molecular detail to assess whether a targeted response is achieved. The primary endpoints are safety and immunogenicity.