Moderna has joined forces with nonprofit organization IAVI for a third phase 1 trial of its HIV vaccine candidate in Africa, where the burden of the virus is still strongly felt.
IAVI (the International AIDS Vaccine Initiative) has begun screening subjects to be included in the study, called IAVI G003, at centers in Rwanda and South Africa, the biotech said.
Moderna’s vaccines deliver HIV-specific antigens discovered by researchers at IAVI and Scripps Research and have already been tested in a proof-of-concept study conducted last year using an adjuvant protein vaccine approach.
There is hope that the mRNA approach, which proved so effective against COVID-19, could succeed where traditional vaccine technologies have failed in HIV.
One candidate – mRNA-1644 – has already shown its potential in a previous Phase 1 study (IAVI G001) conducted in the US. It encodes an antigen called eOD-GT8 60mer and stimulated a targeted B-cell immune response in 97% of vaccine recipients in the study.
Moderna says B-cell activation should lead to the induction of broadly neutralizing antibodies (bnAbs), widely regarded as a target of an effective HIV vaccine, but that immunization with eOD-GT8 60mer alone will almost certainly not suffice.
The biotech is looking at a combination regimen of vaccines targeting different HIV immunogens, such as Core-g28v2 60mer, to try to further boost the immune response against HIV and improve protective efficacy.
Earlier this year, the first healthy volunteers were administered mRNA-1644 in a second Phase 1 study (IAVI G002), funded in part by the Bill & Melinda Gates Foundation and being conducted in US populations.
On HIV Vaccination Day, we would like to recognize and thank the scientists, clinical trial participants, volunteers, and so many others around the world who are working together to raise hopes of a preventive #HIV #vaccine† #WHAT # HVAD2022 pic.twitter.com/KLrVRXtEAv
– Modern (@moderna_tx) May 18, 2022
IAVI G003 will enroll 18 healthy HIV negative adult volunteers who will receive two doses of the eOD-GT8 60mer mRNA injection. They will be followed for six months to measure the safety and immunogenicity of the vaccine.
Moderna said the trial is a “first-in-Africa” study, evaluating an mRNA-supplied HIV immunogen in Africa with African researchers leading the project.
Despite more than 30 years of research, the virus’ tendency to mutate means that classical approaches to vaccine design have been ineffective and that at least four previous vaccine candidates have failed in clinical trials.
In February, one of the leading candidates in the decades-long search for an HIV vaccine — Johnson & Johnson — reported that his candidate had failed a Phase 2b trial.
The Ad26.Mos4.HIV vaccine — which uses the same adenoviral technology as J&J’s COVID-19 vaccine and targets four HIV antigens — showed the injection was safe, but failed to achieve its target to reduce HIV transmission by 50%.
And last year, the HVTN 702 trial of two co-administered HIV candidate vaccines from Sanofi Pasteur and GlaxoSmithKline, combined with GSK’s adjuvant MF59, was also halted due to lack of efficacy.
#Modernas #HIV #vaccine #primed #trials #Africa
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