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March 15, 2022

Moderna reports dosing of first subject in Phase I HIV trimer vaccine trial

The trial will analyse the safety and immunogenicity of the vaccines in nearly 100 HIV-negative adults of the age 18 to 55 years.

Moderna has reported the dosing of the first subject in a Phase I HVTN 302 clinical trial of an investigational human immunodeficiency virus (HIV) trimer messenger ribonucleic acid (mRNA) vaccine, mRNA-1574.

The Division of AIDS (DAIDS) of the US National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases (NIAID) is sponsoring and funding the trial. 

The multicentre, open-label, randomised trial will analyse the safety and immunogenicity of the vaccines by enrolling nearly 100 HIV-negative adults of the age 18 to 55 years.

Scripps Research was awarded NIAID (DAIDS) Consortium for HIV/AIDS Vaccine Development (CHAVD) funding to develop native-like HIV trimers and produce the mRNA-1574 vaccine.

The company anticipates the soluble and membrane-bound HIV envelope trimer mRNA vaccines to be safe and well-tolerated in people who are not HIV infected and induce autologous neutralising antibodies.

Moderna president Stephen Hoge said: “Developing a vaccine regimen that induces sustained protective levels of HIV neutralising antibodies in humans has been difficult to achieve. 

“With the launch of our second HIV vaccine trial, we are advancing our strategy to utilise multiple mRNA encoded native-like HIV trimers and leverage the power of our mRNA platform to accelerate the discovery of a protective HIV vaccine. 

“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.”

Currently, the company is progressing two HIV preventative vaccine approaches based on germline targeting and immune-focusing techniques. 

Apart from the mRNA-1574 vaccine trial, Moderna is collaborating on HIV vaccine antigens, mRNA-1644 and mRNA-1644v2-Core. 

These HIV vaccine antigens are being assessed in an IAVI-sponsored Phase I trial, which is supported by the Bill & Melinda Gates Foundation.

The latest development comes after the company dosed the first subject in Phase II trial of its Omicron-specific bivalent booster candidate, mRNA-1273.214.

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