A Phase 1, placebo-controlled, randomized, participant- and assessor-blind, single-center study to assess the safety and immunogenicity of 2 dose levels of Nipah measles vector (MV-NiV) vaccine administered subcutaneously either as a single dose or as 2 consecutive doses at 4-week interval, in healthy non-exposed volunteers, aged 18-40 years
This research is looking at a new vaccine designed to protect against the Nipah virus, a serious illness. It's a very early-stage study, meaning it's the first time this vaccine is being given to people. We're inviting healthy adults between 18 and 40 years old who have never been in contact with the Nipah virus before. The main goals are to check if the vaccine is safe and to see how well it helps your immune system (your body's defence system) learn to fight the virus. Participants will receive either one or two doses of the vaccine, given just under the skin, or a dummy treatment (placebo).
At a glance
What is this study about?
You might have heard about viruses that cause serious diseases, and scientists are always working to find ways to protect us from them. This particular study is focused on a virus called Nipah. It's a serious illness found in some parts of the world, and currently, there isn't a vaccine approved to prevent it. That's why this research is so important – it's a step towards finding a way to keep people safe from Nipah.
This study is a very early step in developing the vaccine. It's called a 'Phase 1' study, which means it's the first time this new vaccine is being given to people. The main aim is to make sure it's safe for humans and to understand how the body reacts to it. We want to see if your immune system produces a good response that could protect you from the Nipah virus in the future. The vaccine uses a harmless measles virus to deliver parts of the Nipah virus, teaching your body to recognise and fight it off.
To make sure the results are fair and accurate, some participants will receive the actual vaccine, and others will receive a 'placebo', which looks exactly like the vaccine but doesn't contain any active ingredients. Neither you nor the study doctors will know who gets what until the study is over. This helps us get a clear picture of the vaccine's effects. We're testing two different dose levels and seeing if one dose or two doses (given a month apart) works best.
Key takeaways
- This study is for a new Nipah virus vaccine.
- It's a very early-stage trial (Phase 1) focused on safety and immune response.
- Healthy adults aged 18-40 who haven't had Nipah are needed.
- Participants will receive the vaccine or a placebo.
- Your contribution helps develop new ways to protect people from serious diseases.
Who may be eligible?
This study is specifically looking for healthy adults. You must be at least 18 years old, and there's no upper age limit specified, though the detailed information mentions 18-40 years old. Both men and women can take part.
An important requirement is that you must not have been exposed to the Nipah virus before. This helps researchers understand the vaccine's effects on people who haven't already built up any natural protection to the virus.
There will be other health checks to make sure you are generally healthy enough to participate, as the study aims to test the vaccine in people without existing health problems that could affect the results.
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 between 18 and 40 years old?
- Are you generally healthy?
- Have you never been in contact with the Nipah virus?
- Are you able to attend all clinic visits?
What does participation involve?
If you decide to take part, you'll first have a screening visit to check if you're suitable. This will involve health checks and answering questions about your medical history. If you're eligible, you'll receive the vaccine (or placebo) via an injection just under your skin, either as a single dose or as two doses four weeks apart.
You'll have several follow-up visits to the study clinic. During these visits, the research team will monitor your health, ask how you're feeling, and take blood samples. These samples help them check for any side effects and see how your immune system is responding to the vaccine. There will also be a follow-up period after your last dose to ensure your continued safety and track long-term immune responses. The total duration of your participation, including all visits and follow-ups, would be discussed with you in detail.
Potential risks and benefits
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Common questions
What is the Nipah virus?
Nipah virus is a serious infection found in some parts of the world that can cause severe illness in people.
What does 'Phase 1 study' mean?
It means this is the first time this new vaccine is being tested in humans to check if it's safe and how the body reacts to it.
Will I get the actual vaccine or a dummy treatment?
You might get the active vaccine or a dummy treatment (placebo). Neither you nor the study team will know until the study ends.
What's the main goal of this study?
The main goals are to see if the vaccine is safe and how well it helps your body's immune system fight the Nipah virus.
Do I have to pay to join this study?
No, you will not have to pay to participate in the study. All study-related care and treatments are provided at no cost.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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