So, not COVID-19 related, however, this is really exciting news I wanted to share. Phase I trials of Moderna's HIV vaccine candidate, mRNA-1644, which uses the same mRNA technology as our COVID-19 vaccine, is expected to begin clinical trials this month!
Approximately 38 million people worldwide are currently living with HIV with 1.2 million in the U.S. Approximately 2 million new infections of HIV are acquired worldwide every year and approximately 690,000 people die annually due to complications from HIV/AIDS.
mRNA-1644 is a novel approach to HIV vaccine strategy in humans designed to elicit broadly neutralizing HIV-1 antibodies (bNAbs). The Phase 1 study for mRNA-1644 will use iterative testing to validate the approach and antigens and multiple novel antigens will be used
for germline-targeting and immuno-focusing. A second approach, mRNA-1574, is being evaluated in collaboration with the National Institutes of Health (NIH) and includes multiple native-like trimer antigens. Clinical trials are set to begin this year for mRNA-1574 as well.
The mRNA-1644 trial builds on earlier research by the International AIDS Vaccine Initiative and Scripps Research. Results released earlier this year from a Phase 1 clinical trial showed that 97% of participants who received the vaccine showed the desired immune response!
The eventual goal is to stimulate the immune system to produce broadly neutralizing antibodies that target multiple HIV strains. Additional clinical trials will be needed before a vaccine capable of preventing HIV infection is available.
mRNA technology could have some distinct advantages over more traditional methods due to the nature of HIV- as it has mutated into many different variants over the decades. Our mRNA platform makes it easy to develop vaccines against variants because it just requires an update to
the coding sequences in the mRNA that code for these variants, so we are really hopeful this could possibly lead to an HIV breakthrough. Estimated study start date is October 15th!
You can find out more here: investors.modernatx.com/static-files/f…, here: scripps.edu/news-and-event…, here: healthline.com/health-news/to…, and here: clinicaltrials.gov/ct2/show/NCT05…
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