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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]

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

SARS-CoV2 infection

Condition category

Condition code

Infection

Studies of infection and infectious agents

Inflammatory and Immune System

Normal development and function of the immune system

Respiratory

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

SARS-CoV-2 infection identified through participant report and notification to the Queensland notifiable infectious diseases surveillance system.

Timepoint [1]

1 - <3 months, 12 months and five years following the last dose of vaccine or after enrolment for unvaccinated participants

Primary outcome [2]

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]

1 - <3 months, 12 months and five years following the last dose of vaccine or after enrolment for unvaccinated participants

Primary outcome [3]

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]

1 - <3 months, 12 months and five years following the last dose of COVID-19 vaccine received

Secondary outcome [1]

Hospitalisation with a primary diagnosis of COVID-19 assessed via data linkage to Queensland hospitalisation datasets.

Timepoint [1]

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]

Serum IgG antibody to SARS-CoV2 spike protein

Timepoint [2]

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]

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]

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]

Government body

Name [1]

Queensland Health

Address [1]

Prevention Division, Queensland Health
33 Charlotte Street
Brisbane QLD 4001

Country [1]

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]

None

Name [1]

Not applicable

Address [1]

Not applicable

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane and Women’s Hospital HREC (EC00172)

Ethics committee address [1]

Block 7
Royal Brisbane and Women's Hospital
Butterfield Street
HERSTON QLD 4006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/12/2021

Approval date [1]

21/02/2022

Ethics approval number [1]

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

Prof Janet Davies

Address

Director, QoVAX SET Program
Level 7, Block 6
Royal Brisbane and Women's Hospital Campus
Butterfield Street
Herston QLD 4006

Country

Australia

Phone

+61736471047

Fax

[email protected]

Contact person for public queries

Name

Janet Davies

Address

Director, QoVAX SET Program
Level 7, Block 6
Royal Brisbane and Women's Hospital Campus
Butterfield Street
Herston QLD 4006

Country

Australia

Phone

+61736471047

Fax

[email protected]

Contact person for scientific queries

Name

Janet Davies

Address

Director, QoVAX SET Program
Level 7, Block 6
Royal Brisbane and Women's Hospital Campus
Butterfield Street
Herston QLD 4006

Country

Australia

Phone

+61736471047

Fax

[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.	Type	Citation	Email
14560	Study protocol	By request to the QoVAX SET Program	[email protected]
14561	Ethical approval	By request to the QoVAX SET Program	[email protected]
14562	Informed consent form	By 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.

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