Moderna, one of the United States’ (US) leading pharmaceuticals in the fight against COVID-19, is set to undergo the world’s first-ever mRNA-based human trials in HIV vaccine research.
About the Moderna human trials
In a submission listed on the US National Library of Medicine’s Clinical Trials registry, it’s confirmed that Moderna, along with four other collaborators (The University of Texas, George Washington University, Fred Hutchinson Cancer Research Center and Emory University), will undergo a 21-month trial process to determine the safety and immunogenicity of an mRNA-based HIV vaccine candidate.
According to the registry, the first-ever mRNA-based human trials in HIV research are sponsored by the International AIDS Vaccine Initiative.
While at the time this article was published the trial was not recruiting participants, the IAVI did confirm that Phase 1 of the first-in-human clinical trials will be conducted on 56 HIV/AIDS-negative subjects aged between 18 and 50 years.
The first phase of this revolutionary study is expected to run for 10 months, from Thursday 19 August, where subjects will be divided into four groups — two receiving a mix of the vaccine versions and two receiving one or the other.
The purpose of the first phase, according to the documentation found in the registry, is to determine the vaccine’s basic immune response on subjects not infected with HIV.
It is a precautionary step that will guide Phase 2 and 3 which are expected to include subjects living with the virus.
HIV vaccine: Is mRNA the answer to a cure?
This is the first mRNA vaccine candidate against HIV to be trialled on humans. While this antiviral technology has existed for years, its true potential was seen in how effective it was against COVID-19.
Unlike traditional vaccines that inject an inactive virus to train the defences of one’s immune system, the mRNA technology, according to Science Alert, carries an instruction booklet that tutors cells on making “fragments of specific proteins that sit on the outside of the target virus.”
A mRNA-based vaccine helps our cells make these protein spikes within 48 hours, alerting our bodies of this foreign threat. In return, the body mounts an immune response against the virus.
The long-term goal with the HIV vaccine is to use the mRNA technology to alert our bodies of the virus threat and ensure that our immune systems will be quick enough to fight off the virus before it becomes too severe.
Whether this will be the desired outcome remains to be seen when Moderna publishes its final findings in May 2023.