A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults
This research study is looking at a new vaccine called mRNA-1018-H5, designed to protect against pandemic influenza, commonly known as the flu. The main goal is to understand how well this vaccine helps healthy adults aged 18 and over develop protection against the flu after two doses. Researchers will also carefully check for any side effects or reactions to the vaccine to make sure it's safe. Participants will be randomly assigned to receive either the new vaccine or a placebo (a dummy shot that looks like the vaccine but contains no active ingredients). This is a Phase 3 study, meaning it's one of the final steps before a vaccine might be approved for wider use. It's an important step in finding new ways to protect against influenza.
At a glance
What is this study about?
This study is testing a new vaccine for the flu, specifically one designed for a pandemic situation, which is when a new flu virus spreads globally. The vaccine is called mRNA-1018-H5 and uses a modern approach involving mRNA technology. Researchers want to find out two main things: first, how well the vaccine helps your body build up a defence (called immunity) against the flu virus, and second, if the vaccine is safe and what side effects it might cause in adults aged 18 and over, after they've had two doses.
To figure this out, some participants will receive the new vaccine, while others will receive a placebo – a dummy shot that looks exactly like the vaccine but doesn't contain any active ingredients. This comparison helps researchers understand the true effects of the vaccine. This is a common and important part of medical research to ensure any new treatment is effective and safe.
Understanding the safety and effectiveness of new vaccines like mRNA-1018-H5 is crucial. If successful, this research could lead to a valuable tool for protecting public health, especially during a flu pandemic. By taking part, volunteers contribute significantly to medical science and the development of potential future vaccinations.
Key takeaways
- This study is testing a new mRNA flu vaccine in healthy adults.
- It aims to check how well the vaccine boosts your body's protection and if it's safe.
- You might receive the new vaccine or a dummy shot (placebo).
- You need to be generally healthy and at least 18 years old to take part.
- Participation involves clinic visits, blood tests, and health checks.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be a healthy adult aged 18 or older. Even if you have a long-term medical condition, you might still be able to participate as long as it's well-managed and stable. If you are female and could become pregnant, you can join if you are not pregnant or breastfeeding and either cannot get pregnant, or if you can, you must have a negative pregnancy test before starting.
There are several reasons why you might not be able to join. For example, if you've recently been very unwell with a fever or a serious infection, or if you have certain conditions like a history of heart inflammation (myocarditis, pericarditis), or a specific nerve disorder called Guillain-Barre syndrome. Also, if you have a weakened immune system, have recently used certain flu medications or immune-suppressing drugs, or have taken part in a previous pandemic flu vaccine study, you might not be eligible.
Ultimately, the study doctors will review your medical history to make sure that taking part won't put you at any extra risk and that you can follow the study plan. They want to ensure the safety and well-being of all participants while conducting reliable research.
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.
- Are you 18 years old or older?
- Are you generally healthy, or is any long-term medical condition you have stable?
- Do you have a history of heart inflammation (myocarditis or pericarditis)? (If yes, you might not be eligible)
- Have you recently had a fever (over 38.0°C/100.4°F) or been very unwell?
- Are you pregnant or breastfeeding, or planning to become pregnant during the study?
- Have you had certain medications that affect your immune system recently?
What does participation involve?
If you decide to take part in this study, you'll be assigned by chance to either receive the new vaccine or a placebo (a dummy injection). You'll have several visits to the clinic where doctors and nurses will check your health, take blood samples, and ask about any side effects you might be experiencing. These visits will involve physical examinations and discussions about your well-being. More details about the exact number of visits and their timing will be explained thoroughly by the study team.
You will receive two doses of either the study vaccine or placebo. The research team will regularly check in with you, possibly through phone calls or diary entries, to track any reactions you have and to monitor your long-term health. The total duration of your participation in the study, from your first visit to your final follow-up, will be clearly explained to you by the study staff before you make any decisions.
Potential risks and benefits
Locations (36)
- Velocity Clinical Research, San BernardinoVerified postcodeSan Bernardino, United States· Not yet recruiting
- Velocity Clinical Research, SavannahVerified postcodeSavannah, United States· Not yet recruiting
- Velocity Clinical Research, BoiseVerified postcodeMeridian, United States· Not yet recruiting
- Velocity Clinical Research, RockvilleVerified postcodeRockville, United States· Not yet recruiting
- Velocity Clinical Research, OmahaVerified postcodeOmaha, United States· Not yet recruiting
- Velocity Clinical Research, ClevelandVerified postcodeBeachwood, United States· Recruiting
- Velocity Clinical Research, ProvidenceVerified postcodeEast Greenwich, United States· Recruiting
- Velocity Clinical Research, AndersonVerified postcodeAnderson, United States· Not yet recruiting
- Velocity Clinical Research, DallasVerified postcodeDallas, United States· Recruiting
- Velocity Clinical Research, SuffolkVerified postcodeSuffolk, United States· Not yet recruiting
- Velocity Clinical Research-BristolVerified postcodeBristol, United Kingdom· Not yet recruiting
- Velocity Clinical Research - High WycombeVerified postcodeHigh Wycombe, United Kingdom· Not yet recruiting
Common questions
What is an mRNA vaccine?
mRNA vaccines teach your body's cells how to make a piece of a virus. This piece then triggers your immune system to create antibodies, which protect you if you encounter the real virus.
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the real vaccine but contains no active ingredients. It helps researchers fairly compare the effects of the new vaccine.
Will I know if I'm getting the vaccine or the placebo?
During the study, neither you nor the study team will know whether you received the vaccine or the placebo. This is called 'blinding' and helps ensure reliable results.
What happens if I get pregnant during the study?
If you become pregnant while taking part, you should immediately inform the study team. They will provide guidance and ensure your safety and that of the pregnancy.
Can I leave the study at any time?
Yes, you are free to leave the study at any point, for any reason, without it affecting your medical care.
How to find out more
Moderna WeCare Team
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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