None listed
Conditions
Brief summary
The overarching primary research question for the QoVAX SET Statewide study is; In the Queensland community statewide, what level of short-term vaccine humoral immunity induced at one to three months post vaccination is associated with i) protection from community acquired SARS-CoV-2 infection with known or emergent variants of concern, and ii) severe health outcomes of community acquired COVID-19. The QoVAX Statewide study will address these specific research questions; 1. What are the host intrinsic (level of antibody response, , HLA type) and extrinsic factors (socio-economic health determinants, environmental exposures e.g. smoking) associated with i) vaccine efficacy, and ii) severe COVID-19? 2. Do members of the community who identify as Aboriginal and/or Torres Strait and/or South Sea Islander, or as being from diverse ethnic backgrounds, show similar vaccine responses, and associations with i) vaccine efficacy, and ii) severe COVID-19, and the general Queensland population? 3. Do certain pre-existing health conditions (autoimmunity, cancer, immunodeficiency), and medication use effect i) vaccine efficacy, and ii) vulnerability to severe COVID-19? A statewide recruitment campaign will be undertaken and participants will self-enrol via the study website. A questionnaire will be completed and blood samples collected at 1 - < 3 months following the last dose of a COVID-19 vaccine or at enrolment for unvaccinated participants. Participants will be followed over the long term via both repeat questionnaires and data linkage with administrative health datasets to ascertain study outcomes.
Interventions
Any dose of a COVID-19 vaccine in the previous 12 months OR have not been vaccinated. At each study timepoint (baseline and 12 and 24 months post enrolment), participants complete a questionnaire (approx 15 minutes duration) and a subset have a blood sample taken. At each timepoint, participant data are linked to administrative health datasets to ascertain study outcomes. The overall duration of observation for each participant is five years
Sponsors
Metro North Hospital and Health Service
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
People who reside in Queensland who: 1. are 18 years of age or older, 2. have received any of the Pfizer (BNT162b2), Moderna (MRNA-1273) or AstraChAdOx1 or Novavax COVID19 vaccines, the last of which was received between one and three months prior to giving consent OR have not received any COVID-19 vaccines
Exclusion criteria
People who: 1. are unable or decline to give informed consent. 2. do not read well enough the English or translated version of the participant information and consent form, and give informed consent, may be excluded if there is no interpreter available to assist and ensure the individual is properly informed and understands what is involved in participation. 3. do not have access to a smart phone or computer to read the participant information and complete the consent form and fill the questionnaire. 4. People who are unable or unwilling to reach a pathology collection centre to donate samples and/or have a contraindication to venepuncture will be excluded from the specimen subset.
Outcome results
None listed