The NZ Genomics Study is one component of the NZ Gold Study that includes a suite of observational studies to assess the risk of adverse events of special interest following COVID-19 and mpox vaccines in Aotearoa New Zealand using a gold standard approach. The studies are being run by the Global Vaccine Data Network (GVDN). More information is available on our NZ Gold Study webpage.
The NZ Genomics Study is contributing to the investigation of COVID-19 vaccine-related inflammation of the heart (i.e., myocarditis and pericarditis) in a global GVDN study being conducted in Canada.
The global study is investigating three conditions: Guillain-Barré syndrome (GBS) when a person’s own immune system attacks their body’s nerves, vaccine-induced immune thrombotic thrombocytopenia (VITT) or thrombosis with thrombocytopenia syndrome (TTS) when a person has serious blood clots combined with low platelets), and myocarditis and pericarditis (inflammation of the heart).
The purpose of this study
The purpose of the study is to understand more about how genes may contribute to the risk of having an adverse event following COVID-19 vaccination. The long-term goal is to prevent adverse events for those people who may be at risk.
Individual genetic differences in people may be the reason that some people's bodies respond differently to immunisation than others. DNA (the material inside a cell that contains our genes) may play a role in how a vaccine is broken down and used in the body. There are probably other reasons, that we do not yet understand, to explain why some people may experience adverse events or side effects after a vaccine while others do not. Right now, there is no way to know quickly and reliably who has an increased chance of having a vaccine-related adverse event after a COVID-19 vaccine.
This blog by Dr Bruce Carleton, the lead-investigator in Canada, “Unravelling the genetics of adverse events following immunisation” explains how studying genes can make medicines, including vaccines, safer for people.
Who can take part
People who have received at least one COVID-19 immunisation, and:
- Have NEVER had any of the conditions included in the global study OR
- Who HAD myocarditis or pericarditis during the six weeks after receiving a COVID-19 immunisation AND did not have myocarditis or pericarditis in the year before their first COVID-19 immunisation AND their medical records confirm how the doctors diagnosed their condition.
All COVID-19 vaccine types and brands being used around the world are included in the global study and in NZs contribution to the global study.
The information and saliva from around 500 people living in NZ will be analysed together with the information and samples from over 6,000 other people that are being collected from people around the world as part of the global GVDN study.
What participation in this study involves
Participation in the study is voluntary. People who agree to take part in the study can change their mind at any time and do not need to give any reason for their decision. People who are interested in participating in this study will be given a Participant Information Sheet and, if they agree to participate, asked to sign a consent form.
Participants will be asked to complete a questionnaire and provide a sample of saliva by spitting into a special collection tube. They will also be asked for permission for the researchers to look at their vaccination history recorded in the Aotearoa Immunisation Register and, if they had myocarditis or pericarditis, for permission to access hospital records related to their hospital admission. This information will help identify how the doctors diagnosed their condition.
Participating in this study is expected to take around 60 minutes.
There are no known direct or immediate benefits to research participants. However, we hope that the information learned about the role of genes in the risk of adverse events following immunisation may be used in the future to improve the safety of COVID-19 immunisation programmes world-wide.
Participant information and saliva samples
When you consent to participate in this study, you will be assigned a unique study ID number (code) and the tube containing your saliva sample will be labelled with a barcode number. All your information and your saliva sample will be labelled with only your study code and the barcode number from the saliva sample tube. The saliva sample tube will only be labelled with a barcode number.
Only your deidentified (coded) information and saliva sample tube will be sent to the study laboratory of the Canadian Pharmacogenomics Network for Drug Safety (CPNDS) located at the British Columbia Children’s Hospital Research Institute (BCCHRI) in Canada for testing.
Any data in that could identify you (e.g., your name, date of birth, or personal health number [NHI number]) will be stored securely on a server at the University of Auckland and access will be restricted to the Principal Investigator and Research Nurse/Project Manager.
Māori data sovereignty
People may hold beliefs about a sacred and shared value of all or any tissue samples removed. Māori data sovereignty is about protecting information or knowledge that is about (or comes from) Māori people. We recognise the taonga of the data and samples collected for this study. To help protect this taonga:
- The GVDN has a Māori Governance Committee who has been consulted about the collection, ownership, and use of study data.
- People are encouraged to discuss cultural issues associated with sending saliva samples overseas and/or storing their tissue with their family/whānau as appropriate.
- Participants and their family/whānau will be supported if they choose to have a Poroporoaki (farewell ceremony) to acknowledge transfer of their saliva.
- A karakia will be completed in NZ before samples are sent overseas.
Incidental findings will not be uncovered during this study as researchers are only looking for genes that may be related to adverse events after COVID-19 vaccination. Participants will not be given individual results regarding the analyses undertaken in this research project. However, if they are interested, they will be able to obtain general information on the progress of this research project by visiting the GVDN website.
How to get more information or sign up
People who would like to receive a Participant Information Sheet and Consent Form, or ask any questions, can:
Send an email to email@example.com.
Approved by the Health and Disability Ethics Committee reference 2023 FULL 15170
The study investigators are based at Waipapa Taumata Rau, University of Auckland; Starship Children’s Hospital; Auckland City Hospital; Auckland UniServices Limited; and the British Columbia Children’s Hospital Research Institute, Canada.
The NZ Gold Study is supported by Te Whatu Ora – Health New Zealand (HNZ) and the Centers for Disease Control and Prevention (CDC) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award totalling US$10,108,491with 100% funded by CDC/HHS. The contents are those of the author and do not necessarily represent the official views of, nor an endorsement, by CDC/HHS, or the U.S. Government. For more information, please visit cdc.gov.