RSV Vaccine Study
Participants needed: Pregnant women aged 18-40
RSV is a cold-like virus (germ). It infects the airways and lungs. A person with a mild RSV illness may have a cold or a sore throat. A person with severe illness may have problems breathing.
By the age of 2 years almost all children have had an RSV illness. RSV illness is one of the most common reasons why young babies are admitted to the hospital. In severe cases, babies may die from RSV illness. RSV infection can be more serious in young babies, whose airways are still very small and whose immune system cannot fight germs very well. RSV is the most common cause of bronchiolitis (infection of the breathing tubes) and some pneumonia (lung infection) in young babies.
What is the purpose of this study?
This is the first study of this RSV vaccine in pregnant women. We have already studied this vaccine in healthy women who are not pregnant. So far, we know that the vaccine can boost antibodies in these non-pregnant women.
The study will test a smaller dose and a larger dose of the vaccine. Each of these doses has been given safely to about 125 women who are not pregnant.
The study is being done to:
- Make sure the new vaccine is safe for pregnant women and their babies
- Find out how well our vaccine can boost antibodies in pregnant women
- Find out how well the boosted antibodies transferred to the baby
- Measure how long the RSV antibodies stay in the babies’ blood
- Find out how often pregnant women visit a health care provider due to a cold-like illness after they get the vaccine, and if RSV or a different germ caused the illness
- Find out how often their babies get sick with a cold-like illness, and if RSV or a different germ caused the illness.
Am I eligible to participate?
You can take part in this study if you are:
- 18 to 40 years of age.
- Between 28 to 33 weeks pregnant at the time of your vaccination.
- Experiencing an uncomplicated pregnancy and are in good health.
- Willing to consent to have your baby take part in the follow-up study.
There are other criteria that we will review at the screening visit to determine if you are eligible for the study or not.
Participation in the study involves up to 10 scheduled study visits for you and your baby. There are 8 visits for you over a 9 month period and 5 visits for your baby over a 12 month period. Some of the visits are together. You will also be contacted by the study staff monthly by a phone call or email. Throughout the study you will keep a diary in an electronic device, similar to a smart phone. This will be provided to you.
The visits will occur at the Canadian Center for Vaccinology (CCfV) located at the IWK Health Centre or (where possible) at your home. We estimate the total time commitment to participate in the study will be approximately 6-10 hours for you and your baby.
You will receive:
There will be no costs to you to take part in this study. As reimbursement for out-of-pocket expenses such as travel costs to and from study visits, you will receive $50 per visit for each visit and a parking pass at the end of each visit if required (if you park in the IWK parking garage).
Contact Pamela McIntyre