Tdap Vaccine Study
Participants needed: Ages 19-21
About Pertussis, Diphtheria and Tetanus
Pertussis, also known as “whooping cough”, is a highly contagious respiratory disease. Pertussis, is caused by a germ called Bordetella pertussis. The bacteria enter the respiratory system and release substances that cause the airways to swell. These changes to the respiratory system result in coughing fits (uncontrollable, violent coughing) which often makes it hard to breath.
Pertussis can spread easily from person to person. When someone with pertussis coughs or sneezes, he or she releases germs into the air. Pertussis is spread when a healthy person breathes these germs into their mouth, nose, throat, and lungs.
Pertussis vaccines are often mixed with other vaccines that protect against other illnesses such as diphtheria and tetanus. These three combined vaccines can be given as a single shot, which is called tetanus, diphtheria and pertussis vaccine or Tdap. The Tdap vaccine is part of the recommended vaccines for adults.
What is the purpose of this study?
The vaccine to be studied in this clinical study is an investigational Tdap booster vaccine, and is being developed to protect people 10 years of age and older against tetanus, diphtheria and pertussis diseases. A booster vaccine is an additional dose of vaccine needed periodically to help those already vaccinated increase their resistance to infection or immunity.
The investigational Tdap booster vaccine will be compared to a Tdap vaccine licensed in Canada called Adacel®.The vaccine has been made to protect against tetanus, diphtheria and pertussis disease. Older children, teens, and adults usually have milder symptoms.
Are you eligible to participate?
You can take part in this study if:
1. You are between 19-21 years of age.
2. You are available for all the study visits.
3. You are in good health.
4. You have not received a previous Tdap vaccine in the past 4 years.
5. You are willing to use a reliable form of birth control or abstinence (if female) from at least 4 weeks prior to the first vaccination until at least 3 months after the last vaccination.
You will be in the study for about 12 to 14 months, including a 12-month follow-up. Participation in the study involves 6 or 10 study visits depending on which vaccine group you are assigned to. We estimate the total time required to participate in the study will be approximately 2-3 hours if you have 6 study visits or 3-4 hours if you have 10 study visits.
You will receive:
There will be no costs to you to take part in this study. You will receive $50 per visit (to cover travel expenses) for each visit and a parking pass at the end of each visit if required (if you park in the IWK parking garage).
You will receive reimbursement in the form of a $50 gift card at each study visit. If you are in the study group with 6 study visits you will receive $300 total if you complete all the study visits. If you are in the study group with 10 visits you will receive $500 total if you complete all the study visits.
If you prefer, payment can be made by cheque through Dalhousie University. You will be asked to sign a form to receive the cheque. If for any reason you do not complete the study, you will be compensated for the total number of visits completed up to that time and you will receive a cheque approximately 6 weeks after signing the form.
Contact Cathy Brown