mRNA respiratory syncytial virus vaccine launches global clinical trial
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mRNA respiratory syncytial virus vaccine launches global clinical trial
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mRNA respiratory syncytial virus vaccine launches global clinical trial.
Recently, Moderna announced that the Phase 2/3 clinical trial of the candidate vaccine mRNA-1345 has completed the first patient administration for the prevention of respiratory syncytial virus (RSV) infection.
RSV is one of the main causes of respiratory diseases in the elderly and young children.
There is currently no vaccine approved. In the previous phase 1 clinical trial, the geometric mean titers of neutralizing antibodies against RSV-A increased by at least 20 times compared with baseline one month after subjects received a single dose of the vaccine.
RSV is a common respiratory virus that generally causes cold-like symptoms.
RSV infection mainly occurs in autumn, winter and spring.
This virus is one of the main causes of serious respiratory diseases in children under 5 and elderly people over 65, and may progress to serious diseases such as pneumonia.
mRNA-1345 is an mRNA vaccine encoding the F glycoprotein before stable fusion of the virus. Compared with the post-fusion state, it can cause a better neutralizing antibody response.
It uses the same lipid nanoparticles (LNP) as Moderna’s COVID-19 vaccine for delivery, containing optimized protein and codon sequences. Previously, the US FDA has granted mRNA-1345 a fast-track qualification to help adults over 60 years of age prevent RSV.
In a phase 1 clinical trial conducted in young adults, one month after subjects received a single dose of vaccine (100 μg), the geometric mean titers of neutralizing antibodies against RSV-A or RAV-B increased by 21 times and respectively compared with baseline. 11.7 times.
Among the 65-79-year-old elderly, one month after vaccination with a dose of mRNA-1345, the geometric mean titers of neutralizing antibodies against RSV-A or RSV-B increased by 14.2 times and 10.1 times, respectively.
In the elderly, a single vaccination of 50 µg, 100 µg, or 200 µg of mRNA-1345 was well tolerated, and there was no significant dose difference in efficacy.
The multi-center, placebo-controlled Phase 2/3 trial will be conducted in multiple countries and plans to recruit approximately 34,000 subjects.
In addition, Moderna’s respiratory virus research and development project also includes the development of mRNA vaccines against other viruses such as seasonal influenza.
At this year’s R&D Day event, the company pointed out that the ultimate goal of its respiratory virus vaccine is to use an mRNA vaccine to prevent multiple respiratory diseases that threaten people of different ages from children to the elderly.
Reference:
[1] Moderna Announces First Participant Dosed in Phase 2/3 Study of its mRNA Respiratory Syncytial Virus (RSV) Vaccine. Retrieved November 18, 2021, from https://www.businesswire.com/news/home/20211118005257/en/
mRNA respiratory syncytial virus vaccine launches global clinical trial
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