Data

QoVAX Statewide: Long-term COVID-19 Study in adults aged 18 years and older living in Queensland, Australia

Queensland Health

Dataset description

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-enroll 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 enrollment 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. (2023-04-19)
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Source Study

Trial acronym

Not applicable

Trial ID

ACTRN12622000020785

Purpose

Not available

Phase

Not Applicable

Funding

Government body,Queensland Health

Scientific enquiries

Prof Janet Davies

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 int ....
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Key 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

Key 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 questionn ....
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Can healthy volunteers participate?

Yes

 

Population

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

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

Comparison

Control group Uncontrolled

No control group

Outcomes

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

Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

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

When will data be available?

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

Available to whom?

Researchers investigating COVID-19

Available for what types of analyses?

Epidemiological and biological analyses of factors associated with SARS-CoV-2 infection and COVID-19 disease.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au