Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Phase I Study to Evaluate Safety and Immunogenicity of DNA Vaccine N-pVAX1 against Crimean Congo Hemorrhagic Fever (CCHF-NP-1)

This research is looking at a new vaccine, called N-pVAX1, designed to protect against Crimean Congo Hemorrhagic Fever (CCHF). CCHF is a serious illness, and currently, there isn't a widely available vaccine to prevent it. This study is a very early stage of testing, meaning it's the first time this specific vaccine will be given to human volunteers. The main goals are to check if the vaccine is safe and if it helps the body produce a protective response. By understanding these early findings, researchers hope to move closer to developing an effective way to prevent this disease. It's an important step in public health efforts.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Karolinska Institutet

Enrolment target

Start

03 May 2024

Crimean Congo Hemorrhagic Fever

What is this study about?

Imagine your body as having a special army that fights off germs and illnesses. Vaccines work by showing your army a picture of the germ so it knows how to fight it if it ever comes across the real thing. This study is testing a brand new vaccine called N-pVAX1. It's designed to protect people from a serious illness called Crimean Congo Hemorrhagic Fever, or CCHF for short.

CCHF is caused by a virus and can make people very sick, sometimes even dangerously so. Right now, there isn't a vaccine widely available that can prevent CCHF. That's why scientists are working hard to find new ways to protect people, and this new vaccine is one of their promising ideas.

This particular study is a very early step in testing. It's called a 'Phase I' study, which means it's the first time this vaccine is being given to people. The main things the scientists want to find out are whether the vaccine is safe to use and whether it helps your immune system (your body's army) learn to fight off the CCHF virus. If these early tests go well, it could eventually lead to a vaccine that can be used to protect many people from this serious disease.

Key takeaways

This study is testing a new DNA vaccine for Crimean Congo Hemorrhagic Fever (CCHF).
It's a very early-stage study, the first time this vaccine is given to people.
The main goals are to check for safety and whether the body creates a protective response.
Adults aged 18 and over, both men and women, are invited to consider taking part.
Participation involves receiving the vaccine and having regular medical check-ups and blood tests.
You can withdraw from the study at any time without affecting your usual medical care.

Who may be eligible?

This study is open to adults who are 18 years old or older. There is no upper age limit, meaning older adults can also take part. Both men and women are welcome to participate in this research.

However, the study will have other specific health requirements to make sure it's safe for everyone involved. For example, people with certain ongoing health conditions or those taking particular medications might not be able to join. These details are very important for your safety and for making sure the study results are clear.

To find out if you might be suitable, a doctor or nurse from the study team would need to review your full health history. They will check to see if you meet all the necessary health conditions to safely take part.

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 able to attend regular clinic visits?
Are you generally in good health?
Do you understand that this is a new vaccine being tested for the first time in humans?
Are you comfortable with having blood tests and medical examinations?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the investigational vaccine, N-pVAX1. Because this is the first time the vaccine is given to humans, you would be carefully monitored by the study doctors and nurses. This would involve a series of visits to the study clinic over a period of time. At these visits, you would have medical check-ups, blood tests to see how your body is reacting to the vaccine, and possibly other assessments. The study team would explain the exact schedule of these visits and tests before you agree to participate. You would likely need to complete a number of follow-up visits after receiving the vaccine, and the total duration from your first visit to your last follow-up could span several weeks or months. All procedures and tests would be clearly explained to you.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of helping scientists develop a vaccine against a serious illness, contributing to public health. However, as with any new medicine or vaccine, there are potential risks. You might experience side effects like soreness at the injection site, fever, or other reactions. We don't yet know all the possible side effects because this is the first time it’s being tested in people. You would be closely monitored for any reactions, and your safety is the top priority. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Sweden

Common questions

What is Crimean Congo Hemorrhagic Fever (CCHF)?

CCHF is a serious illness caused by a virus, often spread by ticks. It can cause fever, muscle aches, headaches, and bleeding problems.

What does 'Phase I' mean for a study?

Phase I means this is the very first time the vaccine is being given to people. The main goals are to check if it's safe and to see how the body reacts to it.

Will I get CCHF from the vaccine?

No, this is a DNA vaccine, meaning it doesn't contain the live virus. It is designed to teach your body to fight the virus without actually giving you the disease.

How long will I be involved in the study?

The total time you'd be involved, from your first visit to your last check-up, could be several weeks or months. The study team will give you a detailed timeline.

Will I be paid to take part?

The study information doesn't mention payment, but it’s common for studies to cover travel expenses. You should ask the study team about this.