COVID-19 vaccine boost to enhance immunity (The Booster Study)

Phase 2

Completed

• Conditions: COVID-19; Infection - Studies of infection and infectious agents; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12622000411741
• Lead Sponsor: niversity of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-10
• Study Completion: 2023-12-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Aged 18-65 years
•Healthy with no significant immunosuppressive illnesses. These include but are not limited to:
- cancer or treatment of cancer or organ transplantation
- treatment of auto-immune or inflammatory conditions such as inflammatory arthritis or inflammatory bowel disease
- use of corticosteroid, TNF inhibitor, interleukins, interferons, cyclosporine or other immunosuppressive medications
- significant renal or liver disease

• Two or 3 prior doses of a COVID-19 vaccine, the last dose at least 4 months prior to recruitment
•No previous significant adverse events to 2-3 prior doses of COVID-19 vaccine, according to the criteria below. Severe grading indicates the event prevented daily activity, temperature >40.0°C or >10.0 cm in diameter for redness and swelling at the site of injection

- severe systemic events (fatigue, headache, fever, muscle or joint pain)
- severe local events (pain at injection site, redness and swelling
- any event requiring emergency department visit or hospitalisation
•No prior anaphylaxis to any cause, including to prior CIVID-19 vaccines
•No prior cardiac inflammatory condition (myocarditis, pericarditis), including to prior COVID-19 vaccines
•Willing and available to have regular blood and saliva samples taken per the schedule of events
•Willing to be randomly assigned to receive a booster dose of Moderna Bivalent Omicron vaccine either upon enrolment or 3 months later
•Willing to provide a signed and dated informed consent form.

Exclusion Criteria

•Prior COVID-19 infection
•Pregnant or breastfeeding women and women planning to become pregnant
•Unwilling to use reliable contraception around the timing of the vaccine (one month before and one month after)
•Receiving medication that might reduce immune responses. These include but are not limited to:
- systemic corticosteroids
- interleukins
- interferons
- cyclosporine
- systemic chemotherapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of participants with a titre of blood neutralising antibodies to the SARS-CoV-2 Omicron variant of >1:100 in the immediate vaccination group. [ Two weeks after the booster dose of Moderna Bivalent Omicron vaccine]