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First In-Africa Clinical Trial of mRNA HIV Vaccine

Today, the International AIDS Vaccine Initiative (IAVI) and Moderna announced they will soon launch a phase 1 clinical trial for their HIV vaccine candidate, administered with mRNA technology to develop broadly neutralizing antibodies.

Though not for lack of effort, there remains a significant need for an HIV vaccine. Today, Moderna and the International AIDS Vaccine Initiative (IAVI) announced the first in-Africa clinical trial for an HIV vaccine candidate.

IAVI, a nonprofit scientific research organization, and Moderna, a biotechnology company, are preparing to begin participant screenings for the mRNA HIV vaccine antigen, mRNA-1644. The phase 1 vaccine trial will take place at the Center for Family Health Research (CFHR) in Kigali, Rwanda and The Aurum Institute in Tembisa, South Africa.

“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," said Etienne Karita, MD, MSc, MSPH, the director of CFHR. “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.”

mRNA-1644, utilizes Moderna’s messenger RNA (mRNA) technology to deliver a specific class of B cells needed to develop broadly neutralizing antibodies (bnAbs) to fight HIV infection. Inducing bnAbs is considered the primary goal of an HIV vaccine, and this requires B-cell activation.

The IAVI-sponsored clinical trial, IAVI G003, will test the safety and efficacy of vaccination with the HIV immunogen eOD-GT8 60mer, delivered via Moderna’s mRNA platform. eOD-GT8 60mer was developed by IAVI and Scripps Research teams, and was initially tested in the phase 1 clinical trial IAVI G001.

Recent findings from IAVI G001 showed that vaccination with eOD-GT8 60mer as a recombinant protein safely and effectively induced the desired immune responses in 97% of healthy US adult trial participants. IAVI G003 will test the hypothesis that vaccination with eOD-GT8 60mer can induce a similar immune response in African trial participants.

“IAVI G003 is more than just a clinical trial,” said Margaret McCluskey, RN, MPH, MPS, a senior technical adviser for HIV vaccine research at USAID. “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.”

IAVI G003 is expected to enroll 18 healthy, HIV-negative adults. The participants will receive 2 doses of eOD-GT8 60mer mRNA, which contains a portion of viral sequence but cannot cause HIV infection.

All participants in the open-label study will receive the therapy. They will be monitored for safety for 6 months after their second dose, and their immune responses will be examined in molecular detail to evaluate whether the targeted was achieved.

The primary trial endpoints are safety and immunogenicity. Immunogens, antigens that elicit a specific immune response, are intended to promote the early maturation of specific types of B cells into cells that produce bnAbs against HIV.

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