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Trial registered on ANZCTR


Registration number
ACTRN12622000020785
Ethics application status
Approved
Date submitted
23/12/2021
Date registered
11/01/2022
Date last updated
11/10/2022
Date data sharing statement initially provided
11/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
QoVAX Statewide: Long-term COVID-19 Study in adults aged 18 years and older living in Queensland, Australia
Scientific title
QoVAX SET Statewide Long-term COVID-19 Study in adults aged 18 years and older living in Queensland, Australia.
Secondary ID [1] 306093 0
None
Universal Trial Number (UTN)
U1111-1272-7118
Trial acronym
Not applicable
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
COVID-19 324754 0
SARS-CoV2 infection 324755 0
Condition category
Condition code
Infection 322205 322205 0 0
Studies of infection and infectious agents
Inflammatory and Immune System 322206 322206 0 0
Normal development and function of the immune system
Respiratory 322235 322235 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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
Intervention code [1] 322502 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329973 0
SARS-CoV-2 infection identified through participant report and notification to the Queensland notifiable infectious diseases surveillance system.
Timepoint [1] 329973 0
1 - <3 months, 12 months and five years following the last dose of vaccine or after enrolment for unvaccinated participants
Primary outcome [2] 330003 0
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 [2] 330003 0
1 - <3 months, 12 months and five years following the last dose of vaccine or after enrolment for unvaccinated participants
Primary outcome [3] 330004 0
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 [3] 330004 0
1 - <3 months, 12 months and five years following the last dose of COVID-19 vaccine received
Secondary outcome [1] 404561 0
Hospitalisation with a primary diagnosis of COVID-19 assessed via data linkage to Queensland hospitalisation datasets.
Timepoint [1] 404561 0
1 - <3 months, 12 months and five years following the last dose of COVID-19 vaccine received or from enrolment in unvaccinated participants.
Secondary outcome [2] 404562 0
Serum IgG antibody to SARS-CoV2 spike protein
Timepoint [2] 404562 0
1 - <3 months, 12 months and five years following the last dose of COVID-19 vaccine received or from date of enrolment in unvaccinated participants
Secondary outcome [3] 404563 0
gDNA Genomic array sequencing (including targeted HLA sequencing) on blood samples. This an exploratory component of the study to potentially identify genomic susceptibilities to COVID-19 and impaired immune response to COVID-19 vaccines
Timepoint [3] 404563 0
1 - <3 months, 12 months and five years following the last dose of COVID-19 vaccine received or from date of enrolment in unvaccinated participants

Eligibility
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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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 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.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Relationships between the outcomes described above and SARS-CoV-2 spike IgG, demographics, general health and wellbeing, immunocompromised state, type of medication known to lessen immune system, ethnicity, age, HLA-type, comorbidities, socio-economic health determinants and environmental exposures will be examined using regression analysis at three months post vaccination or enrolment if unvaccinated, 12 months and 24 months or more (depending on resource approval). Separate models will be examined for the full study population completing the questionnaire and the subset with biological data. Rates of COVID positive and severe COVID will be compared with the unvaccinated Queensland population.

Medium-term health analysis of participants will be evaluated by integration of test results with vaccine notification data, hospital presentation and admission data as well as MBS and PBS datasets, to investigate vaccine efficacy outcomes in relation to immune response and data on other health and social determinants.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
17/01/2022
Actual
25/03/2022
Date of last participant enrolment
Anticipated
30/09/2022
Actual
30/09/2022
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
20000
Accrual to date
Final
7446
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 310434 0
Government body
Name [1] 310434 0
Queensland Health
Country [1] 310434 0
Australia
Primary sponsor type
Government body
Name
Metro North Hospital and Health Service
Address
Royal Brisbane and Women's Hospital Campus
Butterfield Street
Herston QLD 4006
Country
Australia
Secondary sponsor category [1] 311610 0
None
Name [1] 311610 0
Not applicable
Address [1] 311610 0
Not applicable
Country [1] 311610 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310073 0
Royal Brisbane and Women’s Hospital HREC (EC00172)
Ethics committee address [1] 310073 0
Block 7
Royal Brisbane and Women's Hospital
Butterfield Street
HERSTON QLD 4006
Ethics committee country [1] 310073 0
Australia
Date submitted for ethics approval [1] 310073 0
01/12/2021
Approval date [1] 310073 0
21/02/2022
Ethics approval number [1] 310073 0
HREC/2021/QRBW/81904

Summary
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.
Trial website
https://www.health.qld.gov.au/research-reports/research-projects/qovax-set-covid-19-vaccine-research-program
Trial related presentations / publications
Nil at present
Public notes

Contacts
Principal investigator
Name 116394 0
Prof Janet Davies
Address 116394 0
Director, QoVAX SET Program
Level 7, Block 6
Royal Brisbane and Women's Hospital Campus
Butterfield Street
Herston QLD 4006
Country 116394 0
Australia
Phone 116394 0
+61736471047
Fax 116394 0
Email 116394 0
[email protected]
Contact person for public queries
Name 116395 0
Janet Davies
Address 116395 0
Director, QoVAX SET Program
Level 7, Block 6
Royal Brisbane and Women's Hospital Campus
Butterfield Street
Herston QLD 4006
Country 116395 0
Australia
Phone 116395 0
+61736471047
Fax 116395 0
Email 116395 0
[email protected]
Contact person for scientific queries
Name 116396 0
Janet Davies
Address 116396 0
Director, QoVAX SET Program
Level 7, Block 6
Royal Brisbane and Women's Hospital Campus
Butterfield Street
Herston QLD 4006
Country 116396 0
Australia
Phone 116396 0
+61736471047
Fax 116396 0
Email 116396 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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 (start and end dates)?
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.
How or where can data be obtained?
Currently, by request to the QoVAX SET Program ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14560Study protocolBy request to the QoVAX SET Program  [email protected]
14561Ethical approvalBy request to the QoVAX SET Program  [email protected]
14562Informed consent formBy request to the QoVAX SET Program [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.