By  Mary Hearty

The Phase I clinical trial of an mRNA HIV vaccine antigen is set to commence in Rwanda and South Africa at the Center for Family Health Research (CFHR) and the Aurum Institute respectively.

The clinical trial (also known as IAVI G003) comes after a clinical trial (IAVI G001) done in healthy US adults showed that vaccination with the HIV immunogen induced the targeted immune response in almost all the recipients.

Developed by scientific teams at the International AIDS Vaccine Initiative (IAVI) and Scripps Research, then delivered through Moderna mRNA platform, the HIV vaccine antigen induce similar immune responses in African populations as was seen for IAVI G001, according to the scientists.

“The road to an HIV vaccine has been long and winding. mRNA technology has the potential to accelerate the development of a safe, effective, affordable, and durable HIV vaccine for use throughout the world,” said Mark Feinberg, president and CEO of IAVI.

“IAVI G003 harnesses Moderna’s proven mRNA vaccine technology, a novel HIV vaccine approach developed over many years by IAVI and Scripps Research, and more than two decades of collaboration with scientific centers of excellence in sub-Saharan Africa, supported by USAID. Together, we aim to answer critical research questions that can advance HIV vaccine development that increasingly involves leadership by scientists in countries where a vaccine is needed most.”

The trial which builds on progress in HIV vaccine research is made possible with support from the American people through the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) through the United States Agency for International Development (USAID). Additional support is provided by the Bill & Melinda Gates Foundation through grants to Moderna and to the Collaboration for AIDS Vaccine Discovery (CAVD) Vaccine Immunology Statistical Center (VISC).

“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 in Africa. All participants will receive two doses of the HIV antigen, which contains a portion of the viral sequence and cannot cause an infection with HIV.

The study which is open-label has neither blinding nor randomization, and 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 is expected to be 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.

“I think this is a revolutionary approach to HIV vaccine design and development, and I am hopeful that we are on the path to finally realizing an HIV vaccine,” Etienne Karita, director of CFHR said.

“This is the first time we are evaluating an mRNA-delivered HIV immunogen in Africa with African scientists and researchers at the helm, building on our longstanding partnerships with USAID and IAVI.”

Vinodh Edward, CEO of Aurum South Africa said Aurum has a long history of being involved in vaccine trials, and we have significantly expanded our footprint and scientific capacity in South Africa over the last 15 years in partnership with IAVI and USAID.

“It is exciting for us to be applying that capacity to testing a next-generation HIV vaccine antigen using mRNA. We’ve seen the impact mRNA technology has had on COVID-19, and we look forward to seeing how it can potentially impact HIV,” Edward added.

“IAVI G003 is more than just a clinical trial. This is a first-of-its-kind collaboration to advance emerging science and a new generation of African scientists who are taking HIV vaccine development into the future. USAID is proud to support this historic effort,” Margaret McCluskey, senior technical advisor for HIV vaccine research at USAID stated.

The HIV antigen was originally developed as a protein by William Schief, professor at Scripps Research and executive director of vaccine design at IAVI’s Neutralizing Antibody Center (IAVI NAC), and collaborators.