Nil
ACTRN12621001524886
Not available
Not Applicable
Government body,Queensland Health
Prof Janet Davies
The overarching primary research question for the QoVax SET Mixed Dose 1 and 2 study is; In the Queensland community, do heterologous COVID-19 vaccine doses 1 and 2 compared with homologous doses 1 and 2, offer higher recall levels of spike IgG, spike IgA, neutralizing IgG, and cell mediated immunity at 4 months post dose 2. The QoVAX Mixed Dose 1 and 2 study will address these specific research questions; 1. What are the host intrinsic (HLA type, genetic traits, immunological T and B cell recep .... Read more
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,
1. Unable or decline to give informed consent 2. Have a contraindication to venepuncture 3. Insufficient literacy to read and understand the English or translated version of the participant information and consent forms who do not have a family member or interpreter to assist 4. Do not posses a smart phone or computer to access the participant information and complete the consent form and fill the questionnaire. 5. Are unable or unwilling to reach a pathology collection centre to donate samples.
Yes
Sample Size 586
Min. age 18 Years
Max. age No limit
Sex Both males and females
Condition category COVID-19 , SARS-CoV-2
Condition code Infection , Inflammatory and Immune System , Respiratory
Intervention code Not applicable
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 4 weeks after the COVID-19 booster dose, and 12-months post the date of recruitment.
Control group Active
Homologous COVID-19 vaccines BNT162b2/BNT162b2 (BioNTech, Pfizer) or ChAdOx1/ChAdOx1 (Oxford, AstraZeneca) 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 4 weeks after the COVID-19 booster dose, and at 12-months post the date of recruitment.
Outcome: Serum IgG antibodies titres to the SARS-CoV2 spike protein measured using Abbott Core Laboratories' chemiluminescent microparticle immunoassay (CMIA) Timepoint: 4 - 6 months from the second dose of vaccine and repeated at 4 weeks after the COVID-19 booster dose, and at 12 months following the date of recruitment.
yes
De-identified participant data and biological samples for which the participant has consented to the future use of their data and samples.
Immediately following publication and no end date.
Researchers undertaking projects specific to COVID-19.
Analyses for specific COVID-19 related research approved by a Human Research Ethics Committee.