Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12621001543875
Ethics application status
Approved
Date submitted
8/11/2021
Date registered
12/11/2021
Date last updated
11/10/2022
Date data sharing statement initially provided
12/11/2021
Type of registration
Retrospectively registered
Titles & IDs
Public title
Queensland COVID-19 Vaccination (QoVAX) Safety and Efficacy Trial Pilot Study in adults aged 18 years and over.
Query!
Scientific title
Queensland COVID-19 Vaccination Safety and Efficacy Trial (QoVAX SET) Program – Pilot Phase Study in adults aged 18 years and over.
Query!
Secondary ID [1]
305742
0
None
Query!
Universal Trial Number (UTN)
U1111-1271-3191
Query!
Trial acronym
QoVAX SET Pilot
Query!
Linked study record
This study is related to ACTRN12621001524886, both of which form part of the QoVAX SET Program in Queensland
Query!
Health condition
Health condition(s) or problem(s) studied:
COVID-19
324236
0
Query!
SARS-CoV2 virus immunity
324237
0
Query!
Condition category
Condition code
Respiratory
321722
321722
0
0
Query!
Other respiratory disorders / diseases
Query!
Inflammatory and Immune System
321723
321723
0
0
Query!
Normal development and function of the immune system
Query!
Infection
321764
321764
0
0
Query!
Other infectious diseases
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
False
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
COVID-19 vaccines: BNT162b2 (BioNTech, Pfizer) or ChAdOx1 (Oxford, AstraZeneca)
Participants will be recruited prior to the first dose of vaccine. A participant completed questionnaire and blood and saliva samples are collected prior to vaccination. The survey and blood and saliva specimens are repeated just prior to the second dose of vaccine and then at 4 weeks, 6 months and 12 months post the second dose of vaccine.
Query!
Intervention code [1]
322138
0
Not applicable
Query!
Comparator / control treatment
Nil
Query!
Control group
Uncontrolled
Query!
Outcomes
Primary outcome [1]
329478
0
Serum IgG antibodies to the SARS-CoV2 spike protein measured with the Abbott Architect system
Query!
Assessment method [1]
329478
0
Query!
Timepoint [1]
329478
0
1 month post the second dose of vaccine
Query!
Primary outcome [2]
329480
0
Cytokine response including gamma interferon and other cytokines involved in cell mediated adaptive immune response to virus (IL1 alpha, TNFalpha, IL-2, IL-6, IL-8, IL-10, IL-5) will be tested on either freshly collected whole blood or cryopreserved peripheral blood (QuantiFERON gold assay and by stimulating cryopreserved peripheral blood mono nuclear cells and cytokine bead array analysis (Legendplex) of culture supernatants
Query!
Assessment method [2]
329480
0
Query!
Timepoint [2]
329480
0
1 month post the second dose of vaccine
Query!
Secondary outcome [1]
402764
0
Saliva IgA antibodies to the SARS-CoV2 spike protein
Query!
Assessment method [1]
402764
0
Query!
Timepoint [1]
402764
0
4 weeks, 6 and 12 months post the second dose of vaccine
Query!
Secondary outcome [2]
402765
0
Cytokine response including gamma interferon and other cytokines involved in cell mediated adaptive immune response to virus (IL1 alpha, TNFalpha, IL-2, IL-6, IL-8, IL-10, IL-5) will be tested on either freshly collected whole blood or cryopreserved peripheral blood (QuantiFERON gold assay and by stimulating cryopreserved peripheral blood mono nuclear cells and cytokine bead array analysis (Legendplex) of culture supernatants
Query!
Assessment method [2]
402765
0
Query!
Timepoint [2]
402765
0
6 and 12 months post the second dose of vaccine
Query!
Secondary outcome [3]
402770
0
Serum titre of neutralizing antibody to the SARS-CoV2 spike protein
Query!
Assessment method [3]
402770
0
Query!
Timepoint [3]
402770
0
4 weeks, 6 and 12 months post the second dose of vaccine
Query!
Secondary outcome [4]
402771
0
Serum IgA titres to the SARS-CoV2 spike protein
Query!
Assessment method [4]
402771
0
Query!
Timepoint [4]
402771
0
4 weeks, 6 and 12 months post the second dose of vaccine
Query!
Secondary outcome [5]
402772
0
Whole genome genomic sequencing (human leukocyte antigen and other immune response genes)
Query!
Assessment method [5]
402772
0
Query!
Timepoint [5]
402772
0
4 week, 6 and 12 months post the second dose of vaccine
Query!
Secondary outcome [6]
402773
0
Full blood Immunosenescence profile assessed with differential analysis of lymphocyte subsets CD20, CD4, CD8,CD28, CD56, CD27, with additional CD8 immunosenescence markers; CD28 and CD57. This will be a composite secondary outcome
Query!
Assessment method [6]
402773
0
Query!
Timepoint [6]
402773
0
4 weeks, 6 and 12 months post the second dose of vaccine
Query!
Secondary outcome [7]
402774
0
Local and systemic reactions to vaccines as a composite secondary outcome collected via a participant completed online survey designed specifically for this study
Query!
Assessment method [7]
402774
0
Query!
Timepoint [7]
402774
0
4 weeks post each dose of vaccine
Query!
Eligibility
Key inclusion criteria
People over 18 years of age who:
a) are eligible for the Queensland Health (QH) COVID vaccine program
b) register to receive the vaccine at participating QH sites
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
a) Not resident in Queensland
b) Unable or decline to give informed consent
c) Have a contraindication to venepuncture
d) do not speak/read English well enough to understand the participant information form and complete the surveys
Query!
Study design
Purpose
Screening
Query!
Duration
Longitudinal
Query!
Selection
Defined population
Query!
Timing
Prospective
Query!
Statistical methods / analysis
The proposed analysis of the core research outcomes will initially employ descriptive statistical analysis of continuous variables; for example specific units of IgG binding, titres of neutralizing antibody, and concentrations (picograms/ml) of cytokine induced (e.g. gamma interferon) per ml of blood generated at one month post vaccine boost in comparison to baseline measures for individuals.
Cross-sectional comparative descriptive analysis of distribution of primary outcome measures between genders and between age groups; 18-50 years and over 50 years, and between healthy vaccine recipients, and those who report autoimmune conditions or immune suppression. Multivariate analysis including continuous explanatory variables describing baseline lymphocyte count and subset ratios, proportion of CD8+ T cells expressing activation/senescence markers; CD28, or CD57, percentage of CD20+, CD27+ B cells, with humoral and cellular immune outcomes will be investigated. Furthermore, the presence of genetic markers, including but not limited to human leukocyte antigen classes will be examined in relation to immune response markers (lymphocyte
subsets and induction of SARS-CoV2 spike antibody and whole blood cytokine induction) at one month post vaccination.
Associations with demographic, health, social and wellbeing, medication indicators and immune response outcomes at baseline and one month post vaccine boost will be examined. The effect of other environmental exposures; airborne pollen, air quality indicators (PM2.5, PM10), smoking, or weather (temperature, humidity, precipitation, solar radiation) will be considered in secondary analysis of factors effecting vaccine outcomes and vaccine induced immune responses.
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
6/08/2021
Query!
Date of last participant enrolment
Anticipated
25/02/2022
Query!
Actual
24/06/2022
Query!
Date of last data collection
Anticipated
30/06/2023
Query!
Actual
Query!
Sample size
Target
3000
Query!
Accrual to date
Query!
Final
2159
Query!
Recruitment in Australia
Recruitment state(s)
QLD
Query!
Recruitment postcode(s) [1]
35895
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [2]
35896
0
4006 - Herston
Query!
Recruitment postcode(s) [3]
35897
0
4034 - Boondall
Query!
Recruitment postcode(s) [4]
35898
0
4021 - Kippa-Ring
Query!
Recruitment postcode(s) [5]
35899
0
4870 - Cairns
Query!
Funding & Sponsors
Funding source category [1]
310100
0
Government body
Query!
Name [1]
310100
0
Queensland Health
Query!
Address [1]
310100
0
33 Charlotte Street
Brisbane, QLD, 4001
Query!
Country [1]
310100
0
Australia
Query!
Primary sponsor type
Government body
Query!
Name
Metro North Hospital and Health Service
Query!
Address
Royal Brisbane and Women's Hospital
Herston Road
Herston QLD 4006
Query!
Country
Australia
Query!
Secondary sponsor category [1]
311166
0
None
Query!
Name [1]
311166
0
Query!
Address [1]
311166
0
Query!
Country [1]
311166
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
309791
0
Royal Brisbane and Women’s Hospital HREC (EC00172)
Query!
Ethics committee address [1]
309791
0
Level 7, Block 7 Royal Brisbane and Women's Hospital Campus Herston Road HERSTON QLD 4006
Query!
Ethics committee country [1]
309791
0
Australia
Query!
Date submitted for ethics approval [1]
309791
0
20/05/2021
Query!
Approval date [1]
309791
0
05/07/2021
Query!
Ethics approval number [1]
309791
0
HREC/2021/QRBW/74899
Query!
Summary
Brief summary
The QoVax SET research pilot study is designed to investigate intrinsic and extrinsic host and viral determinants of vaccine safety, immunity and efficacy in Queensland. Specifically, the QoVax SET Program seeks to determine whether the vaccines administered by Queensland Health facilities are safe and effective in the Queensland community to; • Induce SARS-CoV2 immunity, • Limit the severity of virus-induced disease, and • Sustain immunity and protection from SARS-CoV2 disease in QLD.
Query!
Trial website
https://www.health.qld.gov.au/research-reports/research-projects/qovax-set-covid-19-vaccine-research-program
Query!
Trial related presentations / publications
Nil
Query!
Public notes
Query!
Contacts
Principal investigator
Name
115398
0
Prof Janet Davies
Query!
Address
115398
0
QoVAX SET Program
Level 11, Block 7
Royal Brisbane and Women's Hospital Campus
Herston Road
HERSTON QLD 4006
Query!
Country
115398
0
Australia
Query!
Phone
115398
0
+61736471047
Query!
Fax
115398
0
Query!
Email
115398
0
[email protected]
Query!
Contact person for public queries
Name
115399
0
Janet Davies
Query!
Address
115399
0
QoVAX SET Program
Level 11, Block 7
Royal Brisbane and Women's Hospital Campus
Herston Road
HERSTON QLD 4006
Query!
Country
115399
0
Australia
Query!
Phone
115399
0
+61736471047
Query!
Fax
115399
0
Query!
Email
115399
0
[email protected]
Query!
Contact person for scientific queries
Name
115400
0
Janet Davies
Query!
Address
115400
0
QoVAX SET Program
Level 11, Block 7
Royal Brisbane and Women's Hospital Campus
Herston Road
HERSTON QLD 4006
Query!
Country
115400
0
Australia
Query!
Phone
115400
0
+61736471047
Query!
Fax
115400
0
Query!
Email
115400
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
De-identified participant data and biological specimens.
The Guidelines of the NHMRC Management of Data and Information Research (2019), NHMRC Open Access Policy (April 2020 update) and the FAIR (Findable, Accessible, Interoperable, Reusable) data principles will apply.
Query!
When will data be available (start and end dates)?
From 3 months after the primary publication and no end date
Query!
Available to whom?
Researchers investigating SARS-CoV2 and COVID-19 with HREC approval
Query!
Available for what types of analyses?
For analyses specific to studies of SARS-CoV2 and COVID-19
Query!
How or where can data be obtained?
Written request to the Principal Investigator (
[email protected]
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
14001
Informed consent form
Master PICF QoVAX SET Program Pilot Phase v3 17.08.2021
383085-(Uploaded-10-11-2021-13-35-45)-Study-related document.pdf
14002
Ethical approval
2021-07-05 QoVAX SET Pilot MN HREC approval
383085-(Uploaded-08-11-2021-15-55-18)-Study-related document.pdf
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.
Download to PDF