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Cochrane COVID-19 Studienregister
Studienbericht
ACTRN12621001543875Erstmals veröffentlicht: 2022 Jan 28Letzte Aktualisierung: 2022 Jan 28

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

  1. Studientyp
  2. Observational
  1. Studienziel
  2. Prevention
  1. Studiendesign
  2. Cross-sectional
  1. Interventionszuordnung
  2. Not Applicable
Referenzdatensätze

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

ACTRN12621001543875
Eintrag in Studienregister
Keine Ergebnisse
INTERVENTION: 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. CONDITION: COVID-19;SARS-CoV2 virus immunity; ; COVID-19 ; SARS-CoV2 virus immunity Infection - Other infectious diseases Inflammatory and Immune System - Normal development and function of the immune system Respiratory - Other respiratory disorders / diseases PRIMARY 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 [1 month post the second dose of vaccine] Serum IgG antibodies to the SARS-CoV2 spike protein measured with the Abbott Architect system[1 month post the second dose of vaccine] SECONDARY 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 [6 and 12 months post the second dose of vaccine] 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[4 weeks, 6 and 12 months post the second dose of vaccine] Local and systemic reactions to vaccines as a composite secondary outcome collected via a participant completed online survey designed specifically for this study[4 weeks post each dose of vaccine] Saliva IgA antibodies to the SARS-CoV2 spike protein[4 weeks, 6 and 12 months post the second dose of vaccine] Serum IgA titres to the SARS-CoV2 spike protein[4 weeks, 6 and 12 months post the second dose of vaccine] Serum titre of neutralizing antibody to the SARS-CoV2 spike protein[4 weeks, 6 and 12 months post the second dose of vaccine] Whole genome genomic sequencing (human leukocyte antigen and other immune response genes) [4 week, 6 and 12 months post the second dose of vaccine] 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