A Phase 1 Clinical Trial of Adjuvanted Protein-based HCV Vaccine Candidates (HCV Vaccine Trial)
This research is looking at a new vaccine designed to prevent Hepatitis C, a serious liver infection. The main goals are to check if the vaccine is safe for people and if it can help your body create protective antibodies – special cells that fight off germs. This is a "Phase 1" study, which means it's one of the first times the vaccine is being tested in humans. Participants will be healthy adults between 18 and 45 years old. Hepatitis C can lead to severe liver problems, and currently, there isn’t a vaccine to stop it, so finding one is very important.
At a glance
What is this study about?
Hepatitis C is a common virus that mainly affects your liver. It's spread through blood contact, for example, from shared needles or, in the past, through blood transfusions. While treatments exist that can cure Hepatitis C for many people, these treatments are expensive and don't stop you from getting infected again if you’re exposed to the virus. What's more, there's currently no vaccine available to prevent Hepatitis C infection in the first place.
This is why finding a vaccine is so important. If left untreated, Hepatitis C can cause serious liver damage, including lifelong liver problems, liver failure, and even liver cancer. A vaccine could offer a way to protect people, especially those at higher risk, from ever getting this challenging infection.
This particular study is a very early stage of testing, called a Phase 1 trial. This means scientists are primarily focused on two things: making sure the new vaccine is safe for people and checking if it can help your body produce germ-fighting cells, called antibodies, against the Hepatitis C virus. It's a crucial step in developing a potential new shield against this significant health problem.
Key takeaways
- Exploring a new vaccine for Hepatitis C.
- Aimed at healthy adults aged 18-45.
- Checks vaccine safety and ability to create 'germ fighters'.
- Requires commitment for about one year, including local residency.
- Not for those with current Hepatitis C or who are pregnant/breastfeeding.
- Your involvement helps advance medical science.
Who may be eligible?
To join this study, you need to be a healthy adult aged between 18 and 45 years old. It's important that you understand what the study involves and are happy to give your permission to take part. You also need to not be pregnant or breastfeeding, and if you can get pregnant, you must agree to use effective birth control throughout the study. We’ll do some health checks, including a medical history, blood tests, and a physical exam, to make sure you're in good health to participate.
There are also some specific things that would mean you can't join. For example, if you already have Hepatitis C antibodies (meaning you've been exposed to the virus before), or if you've had a bad reaction to a vaccine in the past. You also can't be taking part in another medical study at the same time, or planning to donate blood during this trial.
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 45 years old?
- Are you generally healthy and not currently pregnant or breastfeeding?
- Have you never had Hepatitis C before?
- Are you able to use reliable birth control if you can get pregnant?
- Can you commit to study visits for about a year and stay in the local area?
- Are you NOT currently participating in another medical study?
What does participation involve?
If you decide to take part, you'll receive either the experimental vaccine called AVIHepC1 or a harmless saline (saltwater) injection, both given in your arm. You will need to stay in the local area for about 12 months for follow-up appointments and agree not to travel outside of Canada for at least 14 days after each vaccine shot. During the study, you'll have several visits for blood samples and health checks. You'll also be asked to avoid intense physical exercise for a few days before and after each study shot and blood test. The total duration of your involvement will vary, but it will involve multiple visits over approximately one year to monitor your health and the vaccine's effects.
Potential risks and benefits
Locations (3)
- University of Alberta HospitalVerified postcodeEdmonton, Canada
- Ottawa Hospital - General CampusVerified postcodeOttawa, Canada
- Toronto General Hospital - Toronto Centre for Liver DiseaseVerified postcodeToronto, Canada
Common questions
What is Hepatitis C?
Hepatitis C is a virus that can cause serious damage to your liver over time. It's usually spread through contact with infected blood.
What does 'Phase 1' mean for a study?
Phase 1 means this is one of the first times this new vaccine is being tested in healthy people. The main goals are to check if it's safe and how your body reacts to it.
Will I get the actual vaccine?
You will either receive the experimental Hepatitis C vaccine or a saltwater injection, like a dummy treatment. This is common in studies to compare results.
Can I get pregnant during the study?
No, if you can get pregnant, you must agree not to become pregnant and to use reliable birth control throughout the study to ensure your safety and the study's accuracy.
How long will I be involved in the study?
Your involvement will last for about 12 months, with several visits for check-ups and blood tests during that time.
How to find out more
Kelly Kim, BSc, BA
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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