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

Not Applicable

Active, not recruiting

• Conditions: COVID-19; SARS-CoV2 virus immunity; Respiratory - Other respiratory disorders / diseases; Inflammatory and Immune System - Normal development and function of the immune system; Infection - Other infectious diseases

• Registration Number: ACTRN12621001543875
• Lead Sponsor: Metro North Hospital and Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-12
• Last Update Posted: 16 October 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 2159

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

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

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum IgG antibodies to the SARS-CoV2 spike protein measured with the Abbott Architect system[1 month post the second dose of vaccine];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 [1 month post the second dose of vaccine]