About the CANVAX Study
What is the purpose of this study?
This is a research study that is trying to understand how patients at the MGH Cancer Center respond to the SARS COV-2 (COVID19) vaccine. It will look at symptoms and immune responses to the vaccine or prior infection.
Are you providing the vaccine in this study?
No. The COVID19 vaccine rollout is managed by the Massachusetts Department of Public Health (DPH). You will receive your vaccine through the standard pathways arranged by the DPH, that may include getting it at the hospital or other community vaccine rollout sites.
Why am I being asked to participate in this study?
You are being asked to participate because you are an adult receiving care at the MGH Cancer Center and you may be eligible to receive SARS CoV-2 vaccination at MGH or any community vaccination site (including during future vaccination waves) or have received a SARS CoV-2 vaccine in the last 60 days. There is no limit on the number of patients we aim to include.
Do I have to participate in this study?
No. Taking part in this study is entirely voluntary. Your care will not be affected if you choose not to participate, or withdraw at any time.
What will happen if I agree to participate in this study?
If you agree to participate we will ask you to complete questionnaires and collect blood samples of no more than 30ml (2 tablespoons) from you to test your immune system for antibodies or other immune responses towards the SARS CoV-2 virus. The main timepoint is 4 weeks (up to 60 days) after you receive the final dose of the SARS CoV-2 vaccine. We will tell you the result of the antibody test collected at the main timepoint. If you do not have antibodies after the vaccine we will let you and your doctor know. The blood can be collected when you are at a clinic appointment or an MGH lab. We can send a fingerprick home collection kit with instructions to you so that you can collect blood from a fingerprick and send it back to us for later timepoints.
We may also collect blood/saliva if you are having blood drawn, no more frequently than weekly, or if you chose to receive the home testing kit, at additional timepoints prior to vaccination, after the first dose of the vaccine and 3, 6 and 12 months after you receive the second dose of the vaccine, to look at how long immunity may last. You can choose not to participate in some of these blood draws but still be part of the study. We will not return the results of the tests we perform on these additional timepoints.
We also encourage you to report your symptoms after receiving the vaccine using an application on your phone. If you choose to do this, we can use the data from the symptom app by linking you to the app using your name and email address.
This study also asks your permission to link the results of these analyses with clinical information that has been generated during the course of your clinical care. This way, we can relate your results to your clinical situation like what disease you have and what treatments you have received. Participation in this study is free of any cost to you.
We cannot predict all of the research questions that will be important over the next years. As we learn more, there are new research questions and new types of research related to cancer or vaccination may be done.
How will I benefit from participating in this study?
You will receive the result of your antibody test following the final dose of vaccine. Whilst we do not know exactly what being antibody positive or negative may mean, this may help you and your doctor understand your risk better. By participating you may also help us understand what we can do better to help patients like you in the future. You will not be paid to participate in this research.
Are there risks to me if I participate in this study?
The risks of participating are those of taking of blood such as pain, bruising, bleeding. Your samples and information are kept secure. There are many safeguards in place to protect your information and samples while they are stored in repositories and used for research.
Who will use my samples and see my information?
Your clinical team may see your antibody result in your medical record. Your information will be available to researchers at the MGH Cancer Center or collaborators who are approved by the Institution Review Board as part of the CANVAX study. We will not include your name or other personal identifiers on samples or data we collect. We will use your samples to study immune cells and genetics and those results will not be returned to you or form part of your medical record. We may do genetic research, including a whole genome analysis on your DNA sample, on the DNA in your tissue sample to understand how these link to cancer, immune responses or many diseases or conditions.
DNA is the material that makes up your genes. All living things are made of cells. Genes are the part of cells that contain the instructions which tell our bodies how to grow and work, and determine physical characteristics such as hair and eye color. Genes are passed from parent to child
Your tissue sample may be used to create a living tissue sample (called a “cell line”) that can be grown in the laboratory. This allows researchers to have an unlimited supply of your cells in the future without asking for more samples from you.
Your de-identified information may be used or shared with other researchers without your additional informed consent. Researchers may use your samples and information to develop a new product or medical test to be sold. The hospital, and researchers may benefit if this happens. There are no plans to pay you if your samples or information are used for this purpose.
HIPAA disclaimer and data sharing
We are required by the Health Insurance Portability and Accountability Act (HIPAA) to protect the privacy of health information obtained for research. This is an abbreviated notice, and does not describe all details of this requirement. During this study, identifiable information about you or your health will be collected and shared with the researchers conducting the research. In general, under federal law, identifiable health information is private. However, there are exceptions to this rule. In some cases, others may see your identifiable health information for purposes of research oversight, quality control, public health and safety, or law enforcement. We share your health information only when we must, and we ask anyone who receives it from us to protect your privacy. The National Institutes of Health (NIH) and other central repositories have developed special data (information) banks that analyze data and collect the results of genetic studies and we may deposit your data, with only a code number attached. We do not think that there will be further risks to your privacy and confidentiality by sharing your samples and whole genome information with these banks. However, we cannot predict how genetic information will be used in the future.
What’s next if I want to join?
We are closed for enrollment. If you have already enrolled, we will continue to follow-up with you.
What if I have a questions?
You can send us a message through the contact us section.
If you want to speak with someone not directly involved in this study you can contact the Partners Human Research Committee office on 857 282 1900.