Moderna Takes on Biggest Target Yet, Launching 2nd HIV Trial

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Following recent successes in using messenger RNA (mRNA) vaccines in the prevention of COVID-19, Moderna is now taking on a much bigger target using the technology: human immunodeficiency virus (HIV). On Monday, Moderna announced that the first participant has been dosed in a Phase I trial of its HIV trimer mRNA vaccine, mRNA-1574. 

A lot stands to be gained from a vaccine targeting HIV. Currently, an estimated 38 million people worldwide are infected with HIV, which can lead to acquired immunodeficiency syndrome (AIDS) if left untreated. AIDS is a malicious disease in which the body’s immune system becomes decimated, leaving patients vulnerable to other infections that can have deadly consequences. 

Although those with HIV can be treated with antiretroviral therapy to keep the viral load at an undetectable level preventing harmful consequences and preventing further transmission, it requires patients to be aware they are infected and have access to such care.  

Enter vaccine candidate mRNA-1574. The vaccine is intended to prevent infection with HIV, and the Phase I trial is designed to evaluate the safety and immunogenicity of the vaccine. Modern’s primary hypothesis is that the soluble and membrane-bound HIV trimer mRNA vaccine will be safe, well-tolerated and elicit autologous, or self-made, neutralizing antibodies in HIV-uninfected individuals allowing them immunity from HIV.  

"Developing a vaccine regimen that induces sustained protective levels of HIV neutralizing antibodies in humans has been difficult to achieve. At Moderna, we believe that mRNA offers an opportunity to take a fresh approach to this challenge. With the launch of our second HIV vaccine trial, we are advancing our strategy to utilize multiple mRNA encoded native-like HIV trimers and leverage the power of our mRNA platform to accelerate the discovery of a protective HIV vaccine," said Stephen Hoge, M.D., president of Moderna. "This study is another step in our fight against HIV, as well as other latent viruses such as our recently launched studies in CMV and EBV." 

This Phase I trial, funded by the Division of AIDS of the National Institute of Allergy and Infectious Diseases within the National Institutes of Health, follows Moderna’s announcement in January 2022 of another HIV vaccine trial evaluating its candidate mRNA-1644. The goal of the trial is to assess the sequential administration of priming and boosting HIV immunogens in inducing specific classes of B-cell responses and guiding their early maturation toward broadly neutralizing antibody development. 

Moderna is paving the way with its vaccine candidates which are the first to use mRNA technology in a potential HIV vaccine. mRNA represents an exciting component in the field of vaccine development because it can induce the body’s cells to make proteins that will teach the immune system to trigger a response if it comes in contact with such proteins later on. 

With the COVID-19 pandemic bringing to light new advancements in mRNA technology that may have otherwise taken years to develop, researchers are looking towards other infectious diseases to potentially prevent with mRNA vaccines, including malaria, tuberculosis and Hepatitis B.    

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