COVID-19 vaccine study in persons with and without HIV: information for prospective participants

What is the purpose of this study?

Our study seeks to understand immune responses to COVID-19 vaccines among people living with HIV, and those without HIV.  We also seek to understand whether COVID-19 vaccines may have any effect on the HIV strains that persist in the body even during HIV treatment.

 

Who is doing the study?

Scientists at the BC Centre for Excellence in HIV/AIDS, SFU, Providence Health Care and UBC are doing this study. The lead scientist is Dr. Zabrina Brumme.

 

Who can participate?

You may be able to participate if you are:

  • An adult aged 19 years or older who is generally in good health
  • Planning to receive a COVID-19 vaccine when you are eligible
  • For people living with HIV: undetectable viral load (below 40 copies/mL) for at least one year on a stable antiretroviral treatment (one “blip” to less than 1000 copies/mL is OK)

 

Who cannot participate?

You cannot participate if you have already been vaccinated for COVID-19. If you are person without HIV, you cannot participate if you have any health condition or are taking any medication that could reduce your immune response to vaccines. There are some other exclusion criteria too; please contact the study team for more information.

 

If I participate, will I get the vaccine faster?

No. Participation in the study will not influence how quickly you will become eligible to get the COVID-19 vaccine in BC.

 

What will I be asked to do?

You will complete a minimum of four or five visits over the course of approximately one year (the number depends on what vaccine you get). The first visit needs to happen before you get your first COVID-19 vaccine dose. Each visit will involve a blood draw (84 mL, or about 5.5 tablespoons for participants with HIV; and 44 mL, or about 3 tablespoons, for participants without HIV). Each visit will take about 20 minutes. We will also ask you to complete a baseline survey questionnaire (20 minutes) and periodic follow-up questionnaires (less than 10 minutes). These are completed online. There are also one-page “diaries” to record any side effects you experience from the vaccine, and any symptoms that you experience if you get COVID-19 during the study. We may also access specific information in your health records that are relevant to study data interpretation. Your study results may be put into a national COVID-19 research database.

 

What are the potential benefits of participation?

You will not receive any direct benefit from participating, but we hope that the information learned from this study will help protect people from COVID-19. Also, if you choose to participate, you can request the results of your COVID-19 antibody tests to “track” your responses to the vaccine over time.

 

Will I be remunerated?

We will provide a small honorarium for every regular study visit completed.

 

How will my privacy be protected?

Your name will not appear on your blood samples, any published research or any research database. To protect your identity, we will assign a unique coded identifier to your blood samples and data. The records linking you to this unique code will be safeguarded by Dr. Zabrina Brumme. Only approved researchers will have access to your samples, and you will not be identifiable by technical staff performing the tests.

 

What if participate and then change my mind?

You can withdraw any time without giving reasons.

 

Interested? Please contact us at 604 376-1787 (text OK), or by email at [email protected]

Note: If you choose to be contacted by email, you need to know that emails sent to some webmail services (e.g. Gmail, Hotmail, etc.), may be stored/routed outside of Canada (for example, in the United States) and governed by foreign laws. Due to the fact that future emails will contain personal information about you, including your name and information about your health, the Freedom of Information and Protection of Privacy Act requires that we obtain your consent before we continue. All of the information which you provide to us will be kept completely confidential. Providing your email address means that you voluntarily agree and give your consent for the study team to use email to communicate with you.