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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.
Scientific title
Queensland COVID-19 Vaccination Safety and Efficacy Trial (QoVAX SET) Program – Pilot Phase Study in adults aged 18 years and over.
Secondary ID [1] 305742 0
None
Universal Trial Number (UTN)
U1111-1271-3191
Trial acronym
QoVAX SET Pilot
Linked study record
This study is related to ACTRN12621001524886, both of which form part of the QoVAX SET Program in Queensland

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV2 virus immunity 324237 0
COVID-19 324236 0
Condition category
Condition code
Respiratory 321722 321722 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 321723 321723 0 0
Normal development and function of the immune system
Infection 321764 321764 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 322138 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 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
Timepoint [1] 329480 0
1 month post the second dose of vaccine
Primary outcome [2] 329478 0
Serum IgG antibodies to the SARS-CoV2 spike protein measured with the Abbott Architect system
Timepoint [2] 329478 0
1 month post the second dose of vaccine
Secondary outcome [1] 402771 0
Serum IgA titres to the SARS-CoV2 spike protein
Timepoint [1] 402771 0
4 weeks, 6 and 12 months post the second dose of vaccine
Secondary outcome [2] 402764 0
Saliva IgA antibodies to the SARS-CoV2 spike protein
Timepoint [2] 402764 0
4 weeks, 6 and 12 months post the second dose of vaccine
Secondary outcome [3] 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
Timepoint [3] 402765 0
6 and 12 months post the second dose of vaccine
Secondary outcome [4] 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
Timepoint [4] 402773 0
4 weeks, 6 and 12 months post the second dose of vaccine
Secondary outcome [5] 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
Timepoint [5] 402774 0
4 weeks post each dose of vaccine
Secondary outcome [6] 402772 0
Whole genome genomic sequencing (human leukocyte antigen and other immune response genes)
Timepoint [6] 402772 0
4 week, 6 and 12 months post the second dose of vaccine
Secondary outcome [7] 402770 0
Serum titre of neutralizing antibody to the SARS-CoV2 spike protein
Timepoint [7] 402770 0
4 weeks, 6 and 12 months post the second dose of vaccine

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

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
6/08/2021
Date of last participant enrolment
Anticipated
25/02/2022
Actual
24/06/2022
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
3000
Accrual to date
Final
2159
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 35898 0
4021 - Kippa-Ring
Recruitment postcode(s) [2] 35896 0
4006 - Herston
Recruitment postcode(s) [3] 35899 0
4870 - Cairns
Recruitment postcode(s) [4] 35895 0
4101 - South Brisbane
Recruitment postcode(s) [5] 35897 0
4034 - Boondall

Funding & Sponsors
Funding source category [1] 310100 0
Government body
Name [1] 310100 0
Queensland Health
Country [1] 310100 0
Australia
Primary sponsor type
Government body
Name
Metro North Hospital and Health Service
Address
Royal Brisbane and Women's Hospital
Herston Road
Herston QLD 4006
Country
Australia
Secondary sponsor category [1] 311166 0
None
Name [1] 311166 0
Address [1] 311166 0
Country [1] 311166 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309791 0
Royal Brisbane and Women’s Hospital HREC (EC00172)
Ethics committee address [1] 309791 0
Ethics committee country [1] 309791 0
Australia
Date submitted for ethics approval [1] 309791 0
20/05/2021
Approval date [1] 309791 0
05/07/2021
Ethics approval number [1] 309791 0
HREC/2021/QRBW/74899

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115398 0
Prof Janet Davies
Address 115398 0
QoVAX SET Program
Level 11, Block 7
Royal Brisbane and Women's Hospital Campus
Herston Road
HERSTON QLD 4006
Country 115398 0
Australia
Phone 115398 0
+61736471047
Fax 115398 0
Email 115398 0
QoVAXSETProgram@health.qld.gov.au
Contact person for public queries
Name 115399 0
Janet Davies
Address 115399 0
QoVAX SET Program
Level 11, Block 7
Royal Brisbane and Women's Hospital Campus
Herston Road
HERSTON QLD 4006
Country 115399 0
Australia
Phone 115399 0
+61736471047
Fax 115399 0
Email 115399 0
QoVAXSETProgram@health.qld.gov.au
Contact person for scientific queries
Name 115400 0
Janet Davies
Address 115400 0
QoVAX SET Program
Level 11, Block 7
Royal Brisbane and Women's Hospital Campus
Herston Road
HERSTON QLD 4006
Country 115400 0
Australia
Phone 115400 0
+61736471047
Fax 115400 0
Email 115400 0
QoVAXSETProgram@health.qld.gov.au

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 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.
When will data be available (start and end dates)?
From 3 months after the primary publication and no end date
Available to whom?
Researchers investigating SARS-CoV2 and COVID-19 with HREC approval
Available for what types of analyses?
For analyses specific to studies of SARS-CoV2 and COVID-19
How or where can data be obtained?
Written request to the Principal Investigator (QoVAXSETProgram@health.qld.gov.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14001Informed consent formMaster PICF QoVAX SET Program Pilot Phase v3 17.08.2021   383085-(Uploaded-10-11-2021-13-35-45)-Study-related document.pdf
14002Ethical approval2021-07-05 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.