New mRNA vaccine trial
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’
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
UK Vaccine Innovation Pathway (VIP) and the NIHR working together to accelerate vaccine trials in the UK.
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://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
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