ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622000411741

Ethics application status

Approved

Date submitted

21/02/2022

Date registered

10/03/2022

Date last updated

11/08/2024

Date data sharing statement initially provided

10/03/2022

Date results provided

1/03/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

COVID-19 vaccine boost to enhance immunity in healthy adults aged 18-65 (The Booster Study)

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

COVID-19

Condition category

Condition code

Infection

Studies of infection and infectious agents

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A booster dose of the Moderna Bivalent Omicron vaccine delivered intramuscularly on enrolment

Intervention code [1]

Prevention

Intervention code [2]

Treatment: Drugs

Comparator / control treatment

A booster dose of the Moderna Bivalent Omicron vaccine (0.5 mL) delivered intramuscularly at 3 months post- enrolment..

Control group

Active

Outcomes

Primary outcome [1]

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.

Timepoint [1]

Two weeks after the booster dose of Moderna Bivalent Omicron vaccine

Secondary outcome [1]

A composite outcome of the number of reported adverse events (AEs) and serious adverse events (SAEs) in the immediate arm and the deferred arms, as recorded in the electronic case report form (CRF). Data will be collected by study staff from participants at study visits.
Specific AEs to be collected (using a specified Grade 1 - Grade 4 scale)
1) systemic events : headache, fatigue, new or worsened muscle pain, new or worsened joint pain
2) local reactions: pain at injection site, redness, swelling
3) Fever scale
4) Clinical symptoms of myocarditis/pericarditis: chest pain, shortness of breath, feelings of a fast-beating/fluttering or pounding heart

Serious adverse events as defined by the TGA Note for Guidance on Clinical Safety Management: Definitions and Standards for Expedited Reporting (CPMP/ICH/377/95)

Timepoint [1]

At days 3, 5 and 7 after the receipt of the third vaccine dose in the immediate arm; which corresponds to at days 87, 89 and 91 in the deferred arm

Secondary outcome [2]

The difference in mean titre of blood neutralising antibodies to the SARS-CoV-2 Omicron variant in the immediate compared to that in the delayed vaccination arm.

Timepoint [2]

At time points D0 (receipt of 3rd dose), D3, D5, D7, D28, D84 and D168 in the immediate arm, which corresponds to time points D84, 87, 89, 91, 112 and 168 in the deferred arm

Secondary outcome [3]

durability of mean titre of saliva neutralising antibodies to SARS-CoV-2

Timepoint [3]

day 14, day 28, day 84 and 168 in the immediate arm; which corresponds to day 98, day 112 and day 168 in the deferred arm

Eligibility

Key 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.

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key 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

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 2

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

31/03/2022

Actual

4/11/2022

Date of last participant enrolment

Anticipated

30/09/2022

Actual

30/01/2023

Date of last data collection

Anticipated

31/10/2023

Actual

2/12/2023

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

16 Marcus St
Canberra, ACT 2061

Country [1]

Australia

Primary sponsor type

University

Name

University of Melbourne

Address

Grattan St
Parkville, Vic 3010

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Melbourne Hospital Human Research Ethics Committee

Ethics committee address [1]

Level 2
South West
300 Grattan Street
Parkville Victoria 3050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

06/10/2021

Ethics approval number [1]

HREC/78656/MH-2021

Summary

Brief summary

This study is a randomised open-label trial of the Moderna Omicron-containing bivalent booster candidate mRNA-1273.214 (mRNA-1273.214) vaccine. Participants who have received 2-3 prior doses of the any COVID-19 vaccine will be randomised into two arms:  to receive a 3rd dose of the Moderna Bivalent Omicron vaccine on enrolment or 3 months later. Both groups will be followed-up for six months after enrolment.. We hypothesise that there will be a difference in measurable SARS-CoV-2 antibody responses in people who receive a Moderna Bivalent Omicron COVID vaccine booster  immediately on enrolment in the study compared to those who wait an additional three months before receiving a booster dose.

A booster dose of the Moderna Bivalent Omicron r vaccine will be administered intramuscularly.  One dose (0.5 mL) contains 50 micrograms of mRNA-1273.214 (25-µg each ancestral Wuhan-Hu-1 and omicron B.1.1.529 spike SARS-CoV-2 mRNAs)  (embedded in lipid nanoparticles). 
This is a single-site study with interested potential participants attending the Royal Melbourne Hospital for recruitment, the consenting process and study visits.  A total of 64 participants will be recruited (32 per arm).

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Stephen Kent

Address

The Peter Doherty Institute for Infection and Immunity
792 Elizabeth Street
Melbourne, VIC 3000

Country

Australia

Phone

+61 03 8344 9939

Fax

skent@unimelb.edu.au

Contact person for public queries

Name

Jennifer Audsley

Address

The Peter Doherty Institute for Infection and Immunity
792 Elizabeth Street
Melbourne, VIC 3000

Country

Australia

Phone

+61 03 8344 3266

Fax

jennifer.audsley@unimelb.edu.au

Contact person for scientific queries

Name

Stephen Kent

Address

The Peter Doherty Institute for Infection and Immunity
792 Elizabeth Street
Melbourne, VIC 3000

Country

Australia

Phone

+61 03 8344 9939

Fax

skent@unimelb.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

After de-identification, individual participant data that underlie any published results

When will data be available (start and end dates)?

Commencing 3 months after and ending 5 years following article publication

Available to whom?

Investigators whose proposed use of the data has been approved by the Booster Study Protocol Steering Committee

Available for what types of analyses?

For individual participant meta-analysis

How or where can data be obtained?

Proposals may be submitted up to 5 years following article publication. Proposals should be directed to skent@unimelb.edu.au

To gain access data requestors will need to sign a data access agreement. Data will be available for 5 years at The University of Melbourne Research Repository which is found at:
https://melbourne.figshare.com/

What supporting documents are/will be available?

Type	Citation	Link	Email	Other Details	Attachment
Study protocol			skent@unimelb.edu.au
Ethical approval			skent@unimelb.edu.au

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes	https://doi.org/10.1172/JCI181244	https://www.jci.org/articles/view/181244

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Interim results from a phase I randomized, placebo-controlled trial of novel SARS-CoV-2 beta variant receptor-binding domain recombinant protein and mRNA vaccines as a 4th dose booster.	2023	https://dx.doi.org/10.1016/j.ebiom.2023.104878

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically