Not applicable
ACTRN12622000020785
Not available
Not Applicable
Government body,Queensland Health
Prof Janet Davies
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 int .... Read more
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
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 questionn .... Read more
Yes
Sample Size 7446
Min. age 18 Years
Max. age No limit
Sex Both males and females
Condition category COVID-19 , SARS-CoV2 infection
Condition code Infection , Inflammatory and Immune System , Respiratory
Intervention code Not applicable
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
Control group Uncontrolled
No control group
Outcome: SARS-CoV-2 infection identified through participant report and notification to the Queensland notifiable infectious diseases surveillance system.Timepoint: 1 - <3 months, 12 months and five years following the last dose of vaccine or after enrolment for unvaccinated participants
Outcome: Severe COVID-19 disease following the last dose of COVID-19 vaccine or from enrolment in unvaccinated participants. Severe disease is defined a hospitalisation requiring intensive care admission with a primary diagnosis of COVID-19. The outcome will assessed via data linkage to Queensland hospitalisation datasets.Timepoint: 1 - <3 months, 12 months and five years following the last dose of vaccine or after enrolment for unvaccinated participants
Outcome: Participant reported or an Adverse Event Following Immunisation Surveillance System (QLD) report of any adverse event following any dose of a COVID-19 vaccine. Timepoint: 1 - <3 months, 12 months and five years following the last dose of COVID-19 vaccine received
yes
De-identified participant data, including biological specimens will be made available through an integrated data and biobank administered by Queensland Health that is currently in development
Data availability will commence at the end of the recruitment period (31 March 2022) and there will be no specific end-date given the establishment of the data/biobank
Researchers investigating COVID-19
Epidemiological and biological analyses of factors associated with SARS-CoV-2 infection and COVID-19 disease.