Phase 1 Clinical Trial of mRNA-based monovalent influenza vaccine candidate
Participants needed: age 18-45
A Phase 1 randomized, dose escalation study to evaluate the safety, reactogenicity and immunogenicity of a mRNA-based monovalent influenza vaccine candidate in healthy younger and older adults
What is the purpose of this study?
Flu is caused by a virus that is passed from person-to-person by coughing and sneezing or direct contact with an infected person. Flu viruses are around mainly during the fall and winter (flu season). Vaccination against flu (the flu shot) is the best way to protect yourself from catching the flu. But flu viruses are always changing and can be different every year. They change to escape the body’s defence system.
GSK is developing a new flu vaccine based on messenger ribonucleic acid (mRNA). mRNAs are molecules that work like messages for the cells of the body. They disappear after a short while once the message has been received by the body and your immune response (the level of antibodies developed in your blood) has been built. Flu mRNA vaccines teach your cells how to make a small piece of flu virus. This small piece of virus triggers your immune system to respond against a flu virus inside your body. mRNA vaccines can be manufactured more quickly than Flu vaccines that are grown in eggs. As flu viruses change often, making vaccines faster could help target specific flu viruses and protect people better against them (like when flu pandemics is ongoing).
In this study, we will test a new vaccine against one type of influenza (also known as flu) virus. This vaccine has not yet been approved by Health Canada. Therefore, this vaccine is only given to people who participate in this study. This is the first time that this vaccine is being tested in people.
This study is being done to:
- Find out if the vaccine is safe.
- Find out the dose of the vaccine that triggers a strong immune response against flu viruses.
This study will look at how the body reacts to a Flu mRNA vaccine at different doses. We will give study participants different dose levels of this vaccine (this is called dose escalation). The good and bad effects of the mRNA vaccine will be studied.
Am I eligible for the study?
Healthy adults aged 18-45 can participate in the study. Further screening will take place before you receive any doses of vaccine.
You cannot be in another research study while taking part in this study, cannot be pregnant, and cannot be breastfeeding.
What would I be expected to do?
After a screening visit at the clinic, you will be asked to come to the clinic for at least 5 planned visits and be available for at least 1 planned contact (phone calls or email). You may be asked to come for (an) unscheduled visit(s) if the study doctor thinks it is necessary.
Throughout the study, you will be asked to:
- Answer general questions from the study staff about your health, your medical history and all the medications you are taking now or have taken recently.
- Have a physical exam at screening and on the day of vaccination. This will include measuring your vital signs by checking your temperature, blood pressure, heart rate, breathing frequency, as well as listening to your breathing and measuring your oxygen blood level by placing a probe on your finger. We will measure your height and weight at Visit 1. Additional physical exams will be performed at other visits if the study doctor thinks this is needed for your health.
- Receive 1 injection of the vaccine in your arm. A member of the study staff will inject the vaccine into the muscle of your upper arm.
- Stay in the clinic for about 1 hour after the shot. This is so the study doctor or study staff can check on you for any immediate side effects. The staff may ask questions and may examine you during this time. The study staff will tell you what to do after you leave the clinic. They will also let you know when to return to the clinic for your next visit.
- Give urine samples 4 times to check your health before or during the study.
- Give blood samples 5 times. Depending on your study group, about 80 mL (about 6 tablespoons) of blood will be drawn during the entire study. This does not include possible unscheduled visits. Some of the blood samples will be tested to check your health before or during the study. Other blood samples will be tested to find out how your immune system responds to the vaccine.
- If you can get pregnant, you will be asked for a urine sample to test for pregnancy 2 times before receiving the study vaccine. This is to make sure that you are not pregnant during the study. We will tell you the results of the screening process and whether you are eligible to participate in the study or not. If any of the screening results are outside the accepted range for the study, you will be informed, and you will not be able to take part in the study.
- Enter any vaccine side effects into the study’s tracking software (an eDiary app on your phone or an eDiary provided) each day for 29 days. You will also be asked if the study vaccine affects your daily activities.
If you agree to take part in this study, the study doctor may tell your regular doctor that you are taking part in a study, which may include sharing an informed consent form.
The vaccines in the study will not be the vaccines for the 2022 strains of flu. You will be able to receive your regular 2022 flu vaccine after the study is completed, if you wish to.