IAVI and Moderna Launch First-in-Africa Clinical Trial of mRNA HIV Vaccine Development Program - Seite 2

"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. Moreover, 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. "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."

Trial sites are expected to enroll a combined total of 18 healthy, HIV-negative adult volunteers for IAVI G003. All participants will receive two doses of eOD-GT8 60mer mRNA, which contains a portion of the viral sequence and cannot cause an infection with HIV. There is no blinding and no randomization in this open-label study; all participants will receive the intervention. Enrolled participants will be monitored for safety for six months after receipt of the last dose, and their immune responses will be examined in molecular detail to evaluate whether the targeted responses will be achieved. The primary trial endpoints are safety and immunogenicity, defined as the ability of a substance to elicit an immune response.

Trial endpoint analysis for IAVI G003 will be conducted using immunological assays and completed primarily by scientists at the KAVI-Institute for Clinical Research (KAVI-ICR) in Nairobi, Kenya; the Kenya Medical Research Institute-Centre for Geographic Medicine Research-Coast (KEMRI-CGMRC) in Kilifi, Kenya; and in part by scientists at the CAVD-Central Services Facility; IAVI's Neutralizing Antibody Center (IAVI NAC) at Scripps Research, in La Jolla, California; and the VISC.

The CFHR, Aurum Institute, KAVI-ICR, and KEMRI-CGMRC are part of the Accelerate the Development of Vaccines and New Technologies to Combat the AIDS Epidemic (ADVANCE) program and the IAVI-ADVANCE Partner Clinical Research Center (CRC) Network. ADVANCE is a 10-year cooperative agreement with PEPFAR through USAID that provides a platform to further development of an efficacious HIV/AIDS vaccine and strengthen vaccine research capacities in Africa. This initiative has enabled African research institutions and scientists to play key roles in the design and evaluation of novel biomedical prevention products using promising technologies.

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