Queensland COVID-19 Vaccination (QoVAX) Safety and Efficacy Trial Pilot Study in adults aged 18 years and over.
Metro North Hospital and Health ServiceDataset 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.Identifiers
Source Study
Trial name (public)
Queensland COVID-19 Vaccination (QoVAX) Safety and Efficacy Trial Pilot Study in adults aged 18 years and over.Trial acronym
QoVAX SET Pilot
Trial ID
ACTRN12621001543875
Purpose
Not available
Phase
Not Applicable
Funding
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?
Yes
Population
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
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.
Comparison
Control group Uncontrolled
Nil
Outcomes
Outcome: Serum IgG antibodies to the SARS-CoV2 spike protein measured with the Abbott Architect systemTimepoint: 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
Will individual participant data (IPD) for this trial be available?
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?
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