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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/NCT05228730




Registration number
NCT05228730
Ethics application status
Date submitted
5/02/2022
Date registered
8/02/2022
Date last updated
8/02/2023

Titles & IDs
Public title
Evaluation of Full Versus Fractional Doses of COVID-19 Vaccines Given as a Booster in Adults in Australia - Mongolia, Indonesia, Australia Coronavirus (MIACoV).
Scientific title
A Randomised Controlled Trial to Assess the Immunogenicity, Safety, and Reactogenicity of Standard-dose Versus Fractional Doses of COVID-19 Vaccines (Pfizer-BioNTech or Moderna) Given as an Additional Dose After Priming With Pfizer-BioNTech or AstraZeneca in Healthy Adults in Australia-MIACoV
Secondary ID [1] 0 0
81764
Universal Trial Number (UTN)
Trial acronym
MIACoV
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 - Tozinameran - Standard dose
Other interventions - Tozinameran - fractional dose
Other interventions - Elasomeran - standard dose
Other interventions - Elasomeran - fractional dose

Active Comparator: AstraZeneca (ChAdOx1-S, or Vaxzevria®)-Standard Pfizer-BioNTech booster group - Received two doses of AstraZeneca as primary COVID-19 vaccine

Experimental: AstraZeneca (ChAdOx1-S, or Vaxzevria®)-Fractional Pfizer-BioNTech booster group - Received two doses of AstraZeneca as primary COVID-19 vaccine

Active Comparator: AstraZeneca (ChAdOx1-S, or Vaxzevria®) Standard Elasomeran booster group - Received two doses of AstraZeneca as primary COVID-19 vaccine

Experimental: AstraZeneca (ChAdOx1-S, or Vaxzevria®)-Fractional Elasomeran booster group - Received two doses of AstraZeneca as primary COVID-19 vaccine

Active Comparator: Pfizer-BioNTech (BNT162b2, or Comirnaty®)-Standard Pfizer-BioNTech booster group - Received two doses of Pfizer-BioNTech as primary COVID-19 vaccine

Experimental: Pfizer-BioNTech (BNT162b2, or Comirnaty®)-Fractional Pfizer-BioNTech booster group - Received two doses of Pfizer-BioNTech as primary COVID-19 vaccine

Active Comparator: Pfizer-BioNTech (BNT162b2, or Comirnaty®)-Standard Elasomeran booster group - Received two doses of Pfizer-BioNTech as primary COVID-19 vaccine

Experimental: Pfizer-BioNTech (BNT162b2, or Comirnaty®)-Fractional Elasomeran booster group - Received two doses of Pfizer-BioNTech as primary COVID-19 vaccine


Other interventions: Tozinameran - Standard dose
Tozinamrean is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS_CoV-2). A standard dose will be administered on day 0 of the study.

Other interventions: Tozinameran - fractional dose
Tozinamrean is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS_CoV-2). A fractional dose (15mcg) of the intervention will be administered on day 0 of the study.

Other interventions: Elasomeran - standard dose
Elasomeran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2).
A single standard dose (50mcg) of the intervention will be administered on day 0 of the study.

Other interventions: Elasomeran - fractional dose
Elasomeran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2).
A fractional dose (20mcg) of the intervention 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-months post booster vaccination.
Timepoint [1] 0 0
Baseline (pre booster), and 6-months post booster vaccination
Secondary outcome [2] 0 0
SARS-CoV-2 specific neutralising antibodies at baseline (pre booster), 28 days and 6-months post booster vaccination measured by surrogate virus neutralization test (sVNT)
Timepoint [2] 0 0
Baseline (pre booster), 28 days and 6 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), 28 days-, and 6-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), 28 days-, and 6-months post booster vaccination
Secondary outcome [5] 0 0
Number of IFN? producing cells/million PBMCs
Timepoint [5] 0 0
Baseline (pre booster), 28 days-, and 6-months post booster vaccination
Secondary outcome [6] 0 0
Frequency of cytokine-expressing T cells
Timepoint [6] 0 0
Baseline (pre booster), 28 days-, and 6-months post booster vaccination
Secondary outcome [7] 0 0
Cytokine concentrations following PBMCs stimulation
Timepoint [7] 0 0
Baseline (pre booster), 28 days-, and 16-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
6 months post booster vaccination

Eligibility
Key inclusion criteria
1. Have completed two doses of Pfizer-BioNTech or AstraZeneca vaccines with the
recommended schedule 6 months prior to the date of enrolment

2. Willing and able to give written informed consent

3. Aged 18 years or above

4. 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. Received 3 doses of COVID-19 vaccine

2. Received 2 doses of COVID-19 less than 6 months prior to the start of the trial

3. Received a different Covid-19 vaccine not available in Australia

4. Currently on immunosuppressive medication or anti-cancer chemotherapy

5. HIV infection

6. Congenital immune deficiency syndrome

7. Has received immunoglobulin or other blood products in the 3 months prior to
vaccination

8. Study staff and their relatives

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

10. 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 assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/11/2022
Sample size
Target
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Children's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3010 - 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 single-blind, randomised controlled clinical trial to determine the reactogenicity
and immunogenicity of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) vaccines
(Pfizer-BioNTech or Moderna) as booster dose in adults, who have previously received either
Pfizer-BioNTech or AstraZeneca as their primary doses.

Both fractional and standard doses of Pfizer-BioNTech or Moderna will be tested.

The trial intervention will be given in line with Australian Technical Advisory Group on
Immunisation (ATAGI) recommendations for booster vaccine doses which allows booster doses
from 5 months onwards . There will be a total of 8 groups, with 100 individuals of even
spread of participants above and below 50 years in each group. The trial will be single site,
based at Royal Children's Hospital, Melbourne, Australia
Trial website
https://clinicaltrials.gov/ct2/show/NCT05228730
Trial related presentations / publications
Munro APS, Janani L, Cornelius V, Aley PK, Babbage G, Baxter D, Bula M, Cathie K, Chatterjee K, Dodd K, Enever Y, Gokani K, Goodman AL, Green CA, Harndahl L, Haughney J, Hicks A, van der Klaauw AA, Kwok J, Lambe T, Libri V, Llewelyn MJ, McGregor AC, Minassian AM, Moore P, Mughal M, Mujadidi YF, Murira J, Osanlou O, Osanlou R, Owens DR, Pacurar M, Palfreeman A, Pan D, Rampling T, Regan K, Saich S, Salkeld J, Saralaya D, Sharma S, Sheridan R, Sturdy A, Thomson EC, Todd S, Twelves C, Read RC, Charlton S, Hallis B, Ramsay M, Andrews N, Nguyen-Van-Tam JS, Snape MD, Liu X, Faust SN; COV-BOOST study group. Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial. Lancet. 2021 Dec 18;398(10318):2258-2276. doi: 10.1016/S0140-6736(21)02717-3. Epub 2021 Dec 2. Erratum In: Lancet. 2021 Dec 18;398(10318):2246.
Public notes

Contacts
Principal investigator
Name 0 0
Kim Mulholland, MD
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