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Studienbericht
ACTRN12621001524886Erstmals veröffentlicht: 2022 Jan 28Letzte Aktualisierung: 2022 Jan 28

Queensland COVID-19 Vaccination (QoVAX) Safety and Efficacy Trial Program: mixed Dose 1 and 2 Study

  1. Studientyp
  2. Observational
  1. Studienziel
  2. Prevention
  1. Studiendesign
  2. Other
  1. Interventionszuordnung
  2. Not Applicable
Referenzdatensätze

Queensland COVID-19 Vaccination (QoVAX) Safety and Efficacy Trial Program: mixed Dose 1 and 2 Study

ACTRN12621001524886
Eintrag in Studienregister
Keine Ergebnisse
INTERVENTION: Heterologous COVID-19 vaccines (BNT162b2 (BioNTech, Pfizer)/ChAdOx1 (Oxford, AstraZeneca) or ChAdOx1/BNT162b2) for doses 1 and 2 Participants complete a questionnaire and have blood and saliva samples collected at 4 - 6 months post the second vaccine dose. The questionnaire and samples are repeated at 12-months post the date of recruitment. CONDITION: COVID-19;SARS-CoV-2; ; COVID-19 ; SARS-CoV-2 Infection - Other infectious diseases Inflammatory and Immune System - Normal development and function of the immune system Respiratory - Other respiratory disorders / diseases PRIMARY OUTCOME: Serum IgG antibodies titres to the SARS-CoV2 spike protein measured using Abbott Core Laboratories' chemiluminescent microparticle immunoassay (CMIA) [4 - 6 months from the second dose of vaccine and at 12 months following the date of recruitment] SECONDARY OUTCOME: Cellular immune responses including IFN-gamma, IL-2 and TNF production. Activation-induced marker (OX40+CD137+) CD4+ T and (CD69+CD137+) CD8+ T cells, memory T cell responses defined using CD45RO, CCR7 and CD62L, and Granzyme-B and Perforin expression by activated CD8 T cells, and CD20+ and CD27+ memory B cells. These will be assessed as a composite secondary outcome [4 - 6 months post the second dose of vaccine and at 12 months following the date of recruitment] Concentration of cytokines in peripheral blood mononuclear cells (IL-1 alpha, IFN-gamma 2, IFN gamma, TNF, MCP-1 CCL2, IL-6, IL-8 CXCL8, IL-10, IL-12p70, IL-17A, IL-18, IL-23 and IL-33) using Biolegend LegendPlex Inflammation Panel Kit. These will be assessed as a composite secondary outcome.[4 - 6 months post the second vaccine dose and at 12 months following the date of recruitment] Genetic array sequences affecting immunity to heterologous and homologous doses of COVID-19 vaccines (human leukocyte antigen loci, other immune response genes). These will be assessed as a composite secondary outcome.[4 - 6 months post second dose of vaccine and at 12 months following the date of recruitment] Immunocompetence assessed via full blood counts with differential analysis of (CD20, CD4, CD8, CD28, CD56, CD27, with additional CD8 immunosenescence markers; CD28 and CD57, and senescent B cells; CD19 pos CD27 neg IgD negative. All components will be assessed as a composite outcome.[4 - 6 months post the second dose of vaccine and at 12 months following the date of recruitment] Participant reported local and systemic reactions following each dose of vaccine. These will be assessed as a composite secondary outcome.[Data collected at 4 -6 months post dose two] Saliva IgA antibody titres to the SARS-CoV-2 spike protein measured using the Euroimmune SARS-CoV-2 domain IgA enzyme-linked immunosorbent assay (ELISA) [4 - 6 months post the second dose of vaccine and 12 months from the date of recruitment] Serum IgA antibody titres to the SARS-CoV-2 spike protein measured using the Euroimmune SARS-CoV-2 domain IgA enzyme-linked immunosorbent assay (ELISA) [4 - 6 months post the second dose of vaccine and at 12 months following the date of recruitment] Serum IgG antibody titres to SARS-CoV-2 nucleocapsid protein measured by using Abbott Laboratories' chemiluminescent microparticle immunoassay (CMIA) [4 -6 months post the second dose of vaccine and at 12 months following the date of recruitment] Titre of neutralizing antibody to the SARS-CoV2 spike protein for variants of concern (UK, RSA. Delta and QLD02), These will be assessed as a composite secondary outcome[4 - 6 months post the second vaccine dose and at 12 months following the date of recruitment ] INCLUSION CRITERIA: People in Queensland 18 years of age and older, who have received two doses of BNT162b2 or ChAdOx1 COVID vaccines, the second of which was received between 120-180 days prior to giving consent,