New mRNA vaccine trials

Intradermal Mycobacterium vaccae and obuense (IMM-101) Oral Non-typeable Haemophilus influenzae (NTHi) UK could be first country to offer norovirus jab against ‘winter vomiting bug’ New vaccine could stop people developing the highly infectious illness after early trial results found it creates a ‘strong immune response’ https://www.telegraph.co.uk/news/2024/10/23/norovirus-vaccine-winter-vomiting-bug-moderna-wes-streeting/ mRNA Systemic distribution inevitable Antigenic dose produced varies Longevity of mRNA? Use of synthetic base Contamination from manufacturing process https://www.nihr.ac.uk/news/uks-first-norovirus-mrna-vaccine-trial-launched First Phase 3 randomised clinical trial Nova 301 trial, mRNA-1403 Trivalent, targeting three major strains of norovirus mRNA norovirus vaccine, UK wide, 39 sites Sponsored by Moderna, Trial evaluates the efficacy and safety of mRNA-1403 Aims to recruit 2,500 participants, UK, late October to early 2025 Some mobile sites for community visits 25,000 globally Half mRNA, half placebo 18 years + but 60 + wanted Single dose vaccine at the first visit - a jab given in the upper arm. The trial lasts up to 25 months. At least six in-person visits to the clinical trial site, and five phone calls with the trial team. Part of a 10-year partnership between Moderna and the UK Health Security Agency (UKHSA) on behalf of UK Government https://www.gov.uk/government/news/uk-cements-10-year-partnership-with-moderna-in-major-boost-for-vaccines-and-research UK Vaccine Innovation Pathway (VIP) and the NIHR working together to accelerate vaccine trials in the UK. https://bepartofresearch.nihr.ac.uk/?utm_source=nihr-website&utm_medium=referral&utm_campaign=bpor-nova Dr Patrick Moore, Chief Investigator of the trial The UK is really pleased to be able to play an important role in helping find an effective vaccine against this highly contagious disease. NIHR Chief Executive Professor Lucy Chappell Leveraging the UK’s expertise in vaccine development, the DHSC through the NIHR and Moderna are delivering this large-scale trial at pace, so that people across the UK and the world can benefit sooner. From the NIHR site the Nova 301 trial serves as a model for future collaborations between the public and private sectors in advancing medical research. Norovirus https://www.cdc.gov/norovirus/data-research/index.html#:~:text=Economic%20impact,-Norovirus%20illness%20is&text=Every%20year%2C%20norovirus%20is%20estimated,healthcare%20costs%20and%20lost%20productivity. https://emedicine.medscape.com/article/224225-overview Worldwide, about 1 out of every 5 cases of acute gastroenteritis is caused by norovirus. Gastroenteritis typically develops 12-48 hours after ingestion of contaminated food or water or after contact with an infected individual. Symptoms typically last for 24-72 hours. All ages Nausea and vomiting Watery diarrhea Possible dehydration Abdominal cramps Headaches Low-grade fever Myalgias and malaise Norovirus genus More than 40 different strains GII.4 Sydney Transmission Person to person, direct contact, exposure to aerosols, fecal–oral routes. ID50 = 10 virions