Frequently Asked Questions
My Health & Safety
Q. What is the BCG vaccine?
Bacillus Calmette Guerin (BCG) is a well- known, extensively studied vaccine routinely given against tuberculosis. It has been used for more than 80 years and is one of the most widely used vaccines in the world. Previous research has already indicated that BCG might have the ability to improve the body’s immune response and provide protection against other infectious diseases. BCG has been modified to produce a better safety and efficacy profile and has been approved by Health Canada for the purpose of this research study.
Q. Is this vaccination safe? What are the side effects?
The BCG vaccine has been given to billions of people around the world. It has been shown to be safe with adverse events reported as very rare, short-lasting, and mild in nature.
More information about possible side effects, can be found here.
Q. What is the medical benefit of taking this vaccine? How could I benefit?
Previous research has already indicated that BCG might have the ability to improve the body’s immune response and provide protection against other infectious diseases, in particular viral diseases. This means the BCG vaccine might increase the ability of a vaccinated person to fight off a viral disease, like Covid-19. The clinical trial is aimed at gathering further evidence to support this theory.
Individuals vaccinated by the modified BCG could experience the following benefits if they come in contact with someone infected with Covid-19:
- They may present with milder symptoms if they contract the disease, or
- They may present with no symptoms at all compared to an unvaccinated person.
Q. Should I consult with my family physician?
You are not required to consult with your family physician for the purpose of participating in the study but you are encouraged to speak with them to discuss the materials presented in the consent form.
Q. Who will have access to my personal medical information?
While the study team will need your telephone number to connect with you by text or phone call, your data will not be linked with your name or identifiable information. Your medical history and limited clinical information will be stored in a de-identified manner and will only be accessed by:
- Representatives of the University Health Network (UHN) including the UHN Research Ethics Board
- Verity Inc. or their representatives. This is the manufacturer of the drug.
- Representatives of Health Canada
Q. Will I be compensated for my participation in this study?
There will be no cost for participation in this study and you will not be paid for participating in this research study.
Q. Is this vaccine only being tested in Canada?
Similar clinical trials are currently taking place with first responders, including health workers and police services, in the Netherlands, South Africa, Australia, Greece, Germany, Denmark, and the United States.
Clinical Trial / UHN
Q. What is a clinical trial?
Clinical trials are research studies that involve people. They are the final step in a long process that begins with research in a lab and often ends with better, safer treatments for illness, infection and disease.
For more information on clinical trials, please click here.
The University Health Network is running several clinical trials to evaluate new approaches to fight Covid-19. More information on other trials running at UHN can be found here.
Q. How will the clinical trial be run? Where do I go to get vaccinated?
The study team from UHN will operate a remote vaccination clinic at various facilities in the GTA.
If you are interested in participating, please contact the study team at 416-946-4501 x 7510 or email us at email@example.com.
Q. If I am participating in the clinical trial and contract Covid-19, what do I do?
If you contracted or think you may have contracted COVID-19, please visit https://www.ontario.ca/page/covid-19-stop-spread to help stop the spread of COVID-19.
Q. Will I be screened at the start of the clinical trial to determine if I previously had Covid-19 and have since recovered?
You will not be screened at the start of the clinical trial. You will, however, be asked by the study team if you have previously tested positive for Covid-19.
Q. What if I previously had Covid-19, can I still participate?
No. You will not be eligible to participate in the trial if you have already had Covid-19.
Q. Can I withdraw my participation at any time during the trial?
Yes, you can withdraw your participation at any time.
Q. Are there any factors that would make me ineligible to participate?
The following factors would make you ineligible to participate:
- If you have already had Covid-19
- If you have already received the BCG vaccination (except for routine vaccination against tuberculosis in childhood)
- If you have had tuberculosis
- If you are pregnant, or plan to become pregnant in the next seven months
- If you are breastfeeding
- If you have a current suspected viral or bacterial infection
- If you have an immune system deficiency (congenital or caused by disease, drugs, or other therapy)
- If you have a known HIV infection
- If you have had a previous allergic reaction to the BCG vaccine
Q. When will I know the results of the study?
The study is conducted in a blinded manner, which means that neither you nor the staff administering the vaccine will know whether you are receiving BCG or a placebo. This is considered to be the highest standard of clinical trials, and ensures the results of the study are not biased. This also means the results will not be known until the last participant has completed the study (seven months following the last injection). Data analysis is expected in November/December 2021 and all publications will be posted on this website once available.
Q. When the study is complete, will I find out if I was administered the placebo or the vaccine?
Yes, the study participants will be notified by the study team as to whether they were given the placebo or the vaccine. This notification will happen at the end of the clinical trial.
Q. If a COVID-19 vaccine becomes available in the next 7 months, will I be able to receive it if I agree to participate in this study?
There is no known reason why you would not be able to get the COVID-19 vaccine, when available, if you have taken part in this study and received the BCG vaccine