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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12621001524886

Acronym

Nil

Enrollment

586

Registered

2021-11-09

Start date

2022-01-07

Completion date

2022-05-03

Last updated

2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

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 receptor repertoires) and extrinsic factors (socio-economic health determinants, environmental exposures e.g. smoking) associated with variation in immune outcomes following vaccination? 2. Do members of the community who identify as Aboriginal and/or Torres Strait and/or South Sea Islander, or as being from diverse ethnic backgrounds, show similar vaccine responses? 3. Do certain pre-existing health conditions (autoimmunity, cancer, immunodeficiency), and medication use effect response variation of primary immune outcome measures? Further research objectives are to investigate medium-term health outcomes of vaccinated research participants at 12 months following recruitment, to identify factors associated with i) safety outcomes, and ii) vaccine efficacy outcomes in the study cohort.

Interventions

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.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

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,

Exclusion criteria

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.

Outcome results