A Phase 4 Pragmatic, Randomized Trial to Evaluate the Effectiveness and Safety of mRNA-1273 Variant-Containing Vaccine Formulation Against Severe Outcomes in Adults Aged 50-64 Years Without Risk Factors for Severe COVID-19 (DAN-COVID)
This study is testing an updated version of the Moderna COVID-19 vaccine, called Spikevax. While earlier vaccine studies focused on people most at risk of getting very ill, this study looks at generally healthy adults aged 50 to 64. Researchers want to find out how well this updated jab protects against newer variants of the virus in daily life. They will track whether people who receive the vaccine have fewer doctor visits, hospital admissions, or serious chest infections compared to those who do not. Because this is a 'real-world' trial, researchers mostly use electronic health records to check on participants' health. The findings will help public health services, like the NHS, decide who should be offered booster vaccines in the future.
At a glance
What is this study about?
COVID-19 vaccines have saved millions of lives around the world, but the virus that causes the illness continues to change over time. Because of these changes, scientists have developed updated booster jabs designed to fight newer strains. This study, called DAN-COVID, focuses on an updated version of the Spikevax vaccine (made by Moderna) to see how effective and safe it is.
Most booster programmes prioritise older adults or people with long-term medical conditions who are at higher risk of severe illness. However, doctors also need to know whether healthy adults between 50 and 64 benefit from routine booster jabs. This trial is set up to answer that question by testing the vaccine in everyday healthcare settings.
To measure success, researchers will track how many participants test positive for COVID-19, need to see a doctor, or are admitted to hospital with lung or heart problems. They will also look at safety to ensure the jab does not cause unexpected problems. The results will provide valuable evidence to guide future vaccination policies in the UK and worldwide.
Key takeaways
- Tests an updated Moderna Spikevax booster against newer COVID-19 variants.
- Aims to see if the jab reduces doctor visits and hospital admissions.
- Focuses mainly on healthy adults aged 50 to 64.
- Uses routine health records to follow your progress with minimal clinic visits.
- Taking part is completely voluntary and you can withdraw at any time.
Who may be eligible?
This trial focuses primarily on adults aged between 50 and 64 who are in generally good health and do not have major underlying conditions that put them at high risk of severe COVID-19. Both men and women are welcome to take part.
While the study records list an open age range for initial screening, the main group being evaluated are healthy people in their 50s and early 60s. People with serious long-term illnesses or weakened immune systems may not be eligible, as they usually follow separate, high-priority vaccination pathways.
If you are interested in taking part, a study doctor or nurse will review your medical history to make sure the trial is safe and suitable for your personal circumstances.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am an adult, particularly in the 50 to 64 age bracket.
- I do not have major medical conditions that put me at high risk of severe COVID-19.
- I am willing to receive a COVID-19 booster injection.
- I am comfortable with researchers checking my health records during the trial.
- I can give informed consent to take part.
What does participation involve?
Taking part in this study is designed to fit easily around your everyday routine. Participants are randomly chosen (like flipping a coin) to receive either the updated Spikevax booster injection or standard care. The jab is given as a quick injection into the muscle of your upper arm, just like other common vaccines.
Because this is a 'pragmatic' registry-based trial, you will not need to make lots of extra hospital visits. Instead, researchers follow your progress over several months by securely reviewing official health and laboratory records to see if you test positive for COVID-19 or need medical care.
You may be asked to report any side effects shortly after having the jab, and the study team will remain available if you have questions. Overall follow-up typically lasts for up to one year to see how long protection lasts.
Potential risks and benefits
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Common questions
What vaccine is being tested?
The study tests an updated version of Spikevax, an mRNA COVID-19 vaccine made by Moderna.
Will I have to go to hospital for lots of tests?
No. The trial is designed to be simple, and researchers track your health mainly through routine electronic medical and lab records.
Is the Spikevax jab safe?
Yes, mRNA vaccines have been given to millions of people globally and have a strong safety record. Most side effects are mild and short-lived.
Can I choose whether I get the vaccine?
No, participants are placed into groups randomly by a computer to ensure the study results are fair and reliable.
Can I leave the study if I change my mind?
Yes, you can withdraw at any point without giving a reason, and your normal healthcare will not change.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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