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’

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