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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05658523




Registration number
NCT05658523
Ethics application status
Date submitted
19/12/2022
Date registered
20/12/2022
Date last updated
1/11/2023

Titles & IDs
Public title
COVID-19 Booster Study in Healthy Adults in Australia
Scientific title
A Randomised Controlled Trial to Assess the Immunogenicity, Safety and Reactogenicity of a Bivalent mRNA Moderna COVID-19 Vaccine or a Protein-based Novavax COVID-19 Vaccine Given as a Fourth Dose in Healthy Adults in Australia
Secondary ID [1] 0 0
91108
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Bivalent Moderna
Other interventions - Novavax

Active Comparator: Bivalent Moderna (mRNA-1273.214) - Participants who have received three doses of COVID-19 vaccine, with the last dose at least 6 months prior to the study, will receive a booster dose of bivalent mRNA Moderna COVID-19 vaccine (mRNA-1273.214)
The mRNA-1273.214 encodes the prefusion stabilized S protein of SARS-CoV-2 formulated in RNA-lipid nanoparticles composed of 4 lipids and 1-monomethoxypolyethyleneglycol-2, 3-dimyristylglycerol with polyethylene glycol. 25µg of each mRNA sequence that encode the prefusion stabilized spike glycoproteins of the ancestral SARS-CoV-2 (Wuhan-Hu-1) and the Omicron variant (B.1.1.529 [BA.1]).

Active Comparator: Novavax - Participants who have received three doses of COVID-19 vaccine, with the last dose at least 6 months prior to the study, will receive a booster dose of Novavax COVID-19 protein subunit vaccine.
Novavax contains 5µg of SARS-CoV-2 spike protein and is adjuvanted with Matrix-M. Adjuvant Matrix-M contains, per 0.5 mL dose: Quillaja saponaria saponins fraction A (42.5 micrograms) and Quillaja saponaria saponins fraction C (7.5 micrograms).

No Intervention: Control group- no vaccine - Participants who have received three doses of COVID-19 vaccine, with the last dose at least 6 months prior to the study, will be recruited but will not receive any COVID-19 vaccine.


Other interventions: Bivalent Moderna
A single standard dose of the bivalent Moderna (mRNA-1273.214) COVID-19 vaccine containing equal amounts of mRNAs (25µg of each mRNA sequence) that encode the prefusion stabilized spike glycoproteins of the ancestral SARS-CoV-2 (Wuhan-Hu-1) and the Omicron variant (B.1.1.529 [BA.1]) with mRNAs encapsulated in lipid nanoparticles, will be administered on day 0 of the study.

Other interventions: Novavax
A single dose of Novavax contains 5µg of SARS-CoV-2 spike protein and is adjuvanted with Matrix-M. Adjuvant Matrix-M contains, per 0.5 mL dose: Quillaja saponaria saponins fraction A (42.5 micrograms) and Quillaja saponaria saponins fraction C (7.5 micrograms), will be administered on day 0 of the study.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
SARS-CoV-2 specific Immunoglobulin (Ig)G antibodies at 28-days post booster vaccination
Timepoint [1] 0 0
28-days post booster vaccination
Primary outcome [2] 0 0
Total incidence of solicited reactions (systemic and local)
Timepoint [2] 0 0
Total incidence of solicited reactions will be measured for 7 days post booster vaccination
Secondary outcome [1] 0 0
SARS-CoV-2 specific IgG antibodies at baseline (pre booster), and 6- and 12-months post booster vaccination
Timepoint [1] 0 0
Baseline (pre booster), 6-months and 12-months post booster vaccination
Secondary outcome [2] 0 0
SARS-CoV-2 specific neutralising antibodies at baseline (pre booster), 28 days, 6- and 12-months post booster vaccination measured by surrogate virus neutralization test (sVNT)
Timepoint [2] 0 0
Baseline (pre booster), 6-months and 12-months post booster vaccination
Secondary outcome [3] 0 0
SARS-CoV-2 specific neutralising antibodies at baseline (pre booster), 28 days and 6- months post booster vaccination measured by SARS-CoV-2 microneutralisation assay
Timepoint [3] 0 0
Baseline (pre booster), 6-months and 12-months post booster vaccination
Secondary outcome [4] 0 0
Interferon gamma (IFN?) concentrations in International Units (IU)/mL
Timepoint [4] 0 0
Baseline (pre booster), 6-months and 12-months post booster vaccination
Secondary outcome [5] 0 0
Number of IFN? producing cells/million PBMCs
Timepoint [5] 0 0
Baseline (pre booster), 6-months and 12-months post booster vaccination
Secondary outcome [6] 0 0
Frequency of cytokine-expressing T cells
Timepoint [6] 0 0
Baseline (pre booster), 6-months and 12-months post booster vaccination
Secondary outcome [7] 0 0
Cytokine concentrations following PBMCs stimulation
Timepoint [7] 0 0
Baseline (pre booster), 6-months and 12-months post booster vaccination
Secondary outcome [8] 0 0
Incidence of unsolicited adverse events (AE)
Timepoint [8] 0 0
28 days-post booster vaccination
Secondary outcome [9] 0 0
Incidence of medically attended adverse events (AE)
Timepoint [9] 0 0
3 months post booster vaccination
Secondary outcome [10] 0 0
Incidence of serious adverse events (SAE)
Timepoint [10] 0 0
12 months post booster vaccination

Eligibility
Key inclusion criteria
1. Have received three doses of COVID-19 vaccines at least 6 months earlier.

2. No confirmed SARS-CoV-2 infection on PCR or RAT within the last 3 months.

3. Willing and able to give written informed consent.

4. Aged 18 years or above.

5. Willing to complete the follow-up requirements of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Currently receiving immunosuppressive medication or anti-cancer chemotherapy.

2. Known HIV infection.

3. Congenital immune deficiency syndrome.

4. Received immunoglobulin or other blood products in the three months prior to potential
study booster vaccination.

5. Study staff and their relatives.

6. Have a history of a severe allergic reaction to any COVID-19 vaccines or have a
medical exemption to receiving further COVID-19 vaccines.

7. Cannot read or understand English.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
Accrual to date
Final
497
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Children's Hospital, Murdoch Children's Research Institute - Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Coalition for Epidemic Preparedness Innovations
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The Peter Doherty Institute for Infection and Immunity
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a double-blinded, randomised study to determine the safety, reactogenicity, and
immunogenicity of a bivalent mRNA Moderna COVID-19 vaccine or a protein-based Novavax
COVID-19 vaccine given as a fourth dose in healthy adults in Australia.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05658523
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kim Mulholland, MD/Prof
Address 0 0
Murdoch Childrens Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries