Queensland COVID-19 Vaccination (QoVAX) Safety and Efficacy Trial Pilot Study in adults aged 18 years and over.

Metro North Hospital and Health Service

Dataset description

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 well-being, 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.
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Source Study

Trial acronym


Trial ID



Not available


Not Applicable


Government body,Queensland Health

Scientific enquiries

Prof Janet Davies

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.

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

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

Can healthy volunteers participate?




Sample Size    2159

Min. age    18 Years

Max. age    No limit

Sex    Both males and females

Condition category    COVID-19 , SARS-CoV2 virus immunity

Condition code    Infection , Inflammatory and Immune System , Respiratory


Intervention code Not applicable

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.


Control group Uncontrolled



Outcome: Serum IgG antibodies to the SARS-CoV2 spike protein measured with the Abbott Architect system
Timepoint: 1 month post the second dose of vaccine

Outcome: 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 month post the second dos ....

Read more

Study Protocol: Not Available
Data Dictionary: Not Available

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


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?

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

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