Moderna's experimental vaccines mRNA-1644 and mRNA-1644v2-Core have advanced into Phase I testing, according to a posting Wednesday on the ClinicalTrials.gov website run by the US National Institutes of Health (NIH). The randomised first-in-human study will recruit an estimated 56 HIV-1 uninfected adults in good general health, ages 18 to 50 years old, and is expected to wrap up around May 2023.
According to the posting, the hypothesis behind Moderna's approach with mRNA-1644 is that "sequential vaccination by a germline-targeting prime followed by directional boost immunogens" can induce specific classes of B-cell responses and guide their early maturation toward "broadly neutralising" antibodies.
The trial will be looking at the incidence of treatment-emergent adverse events as a primary outcome measure, and immunogenicity over a 10-month timeframe as a secondary goal, including the proportion of participants with VRC01-class IgG B-cells and serum binding antibody responses. The candidates are being co-developed in collaboration with the International AIDS Vaccine Initiative (IAVI).
Moderna also plans to test a second HIV vaccine approach, dubbed mRNA-1574, that includes multiple native-like trimer antigens. That work is being done in collaboration with the NIH, and the company has said it expects to begin a Phase I trial of mRNA-1574 in 2021 as well.
Moderna has been riding high from the success of its COVID-19 vaccine mRNA-1273, which is projected to bring in sales of around $20 billion this year. It also recently kicked off a Phase I/II trial of its quadrivalent mRNA seasonal influenza vaccine candidate mRNA-1010.
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