Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05228730
Registration number
NCT05228730
Ethics application status
Date submitted
5/02/2022
Date registered
8/02/2022
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).
Query!
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
Query!
Secondary ID [1]
0
0
81764
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
MIACoV
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
COVID-19
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Respiratory
0
0
0
0
Query!
Other respiratory disorders / diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Other - Tozinameran - Standard dose
Treatment: Other - Tozinameran - fractional dose
Treatment: Other - Elasomeran - standard dose
Treatment: Other - 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
Treatment: Other: 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.
Treatment: Other: 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.
Treatment: Other: 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.
Treatment: Other: 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.
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
SARS-CoV-2 specific Immunoglobulin (Ig)G antibodies at 28-days post booster vaccination
Query!
Assessment method [1]
0
0
Serum samples collected at 28-days post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using the commercial Euroimmun S1 IgG ELISA. Data will be reported as binding antibody units/mL and presented as geometric mean concentration and 95% confidence intervals
Query!
Timepoint [1]
0
0
28-days post booster vaccination.
Query!
Primary outcome [2]
0
0
Total incidence of solicited reactions (systemic and local)
Query!
Assessment method [2]
0
0
Questionnaire to document solicited reactions is developed specifically for this study. Data will be reported as the proportion of participants who report by each intervention arm. Solicited reactions such as pain, tenderness, erythema/redness, induration/swelling, fever, nausea/vomiting, headache, fatigue/malaise, myalgia, arthralgia will be collected from the participants 7 days post-vaccination.
Query!
Timepoint [2]
0
0
Total incidence of solicited reactions will be measured for 7 days post booster vaccination
Query!
Secondary outcome [1]
0
0
SARS-CoV-2 specific IgG antibodies at baseline (pre booster), and 6-months post booster vaccination.
Query!
Assessment method [1]
0
0
Serum samples collected at baseline (pre booster), and 6-months post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using the commercial Euroimmun S1 IgG ELISA . Data will be reported as binding antibody units/mL and presented as geometric mean concentration and 95% confidence intervals
Query!
Timepoint [1]
0
0
Baseline (pre booster), and 6-months post booster vaccination
Query!
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)
Query!
Assessment method [2]
0
0
Serum samples collected at baseline (pre booster), 28 days- and 6-months post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific neutralising antibodies using the GenScript® cPass surrogate virus neutralization test (sVNT) for both wild-type and Delta variant. Neutralising antibody response will be reported as percentage (%) inhibition of receptor binding domain-angiotensin-converting enzyme 2 (RBD-ACE2) binding relative to a positive control.
Query!
Timepoint [2]
0
0
Baseline (pre booster), 28 days and 6 months post booster vaccination
Query!
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
Query!
Assessment method [3]
0
0
A subset of samples from all four timepoints will be assessed using a SARS-CoV-2 microneutralisation assay to both the wild type (vaccine) strain and for two SARS-CoV-2 Variants of concern. Neutralizing antibody will be reported as endpoint titre.
Query!
Timepoint [3]
0
0
Baseline (pre booster), 28 days-, and 6-months post booster vaccination
Query!
Secondary outcome [4]
0
0
Interferon gamma (IFN?) concentrations in International Units (IU)/mL
Query!
Assessment method [4]
0
0
Interferon gamma (IFN?) concentrations as a measurement of cellular immunity will be assessed on a subset (40%) of the participants from each group. QuantiFERON Human IFN-? SARS-CoV-2 (Qiagen) will be used to stimulate IFN-? production in peripheral blood mononuclear cells (PBMCs) and then IFN-? production will be measured using ELISA. Data will be presented as geometric mean concentration (GMC) and 95% confidence intervals (CI).
Query!
Timepoint [4]
0
0
Baseline (pre booster), 28 days-, and 6-months post booster vaccination
Query!
Secondary outcome [5]
0
0
Number of IFN? producing cells/million PBMCs
Query!
Assessment method [5]
0
0
IFN? producing cells as a measurement of cellular immunity will be assessed on a subset (40%) of the participants from each group. IFN-? Enzyme-Linked ImmunoSpot (Elispot) assay will be performed on isolated peripheral blood mononuclear cells (PBMCs). Data will be reported as number of IFN? producing cells/million and presented using means and 95% confidence intervals.
Query!
Timepoint [5]
0
0
Baseline (pre booster), 28 days-, and 6-months post booster vaccination
Query!
Secondary outcome [6]
0
0
Frequency of cytokine-expressing T cells
Query!
Assessment method [6]
0
0
Frequency of cytokine-expressing T cells will be assessed on a subset (40%) of participants using Flow cytometry (intracellular staining) on PBMCs samples. Data will be reported as frequency (%) of cytokine-expressing T cells presented as means and 95% CI.
Query!
Timepoint [6]
0
0
Baseline (pre booster), 28 days-, and 6-months post booster vaccination
Query!
Secondary outcome [7]
0
0
Cytokine concentrations following PBMCs stimulation
Query!
Assessment method [7]
0
0
Cytokine concentrations following PBMCs stimulation will be assessed on a subset (40%) of participants using multiplex cytokine assays.Data will be reported as cytokine concentrations in pg/ml and presented as GMC and 95% CI.
Query!
Timepoint [7]
0
0
Baseline (pre booster), 28 days-, and 16-months post booster vaccination
Query!
Secondary outcome [8]
0
0
Incidence of unsolicited adverse events (AE)
Query!
Assessment method [8]
0
0
All unsolicited AE will be collected for 28 days post booster vaccination. Data will be presented as proportion of participants who report unsolicited AE.
Query!
Timepoint [8]
0
0
28 days-post booster vaccination
Query!
Secondary outcome [9]
0
0
Incidence of medically attended adverse events (AE)
Query!
Assessment method [9]
0
0
Participants with medically attended AE will be collected for 3 months post booster vaccination. Data will be presented as proportion of participants who report unsolicited AE.
Query!
Timepoint [9]
0
0
3 months post booster vaccination
Query!
Secondary outcome [10]
0
0
Incidence of serious adverse events (SAE)
Query!
Assessment method [10]
0
0
SAE will be collected throughout the follow-up period of 6 months post booster vaccination. Data will be presented as a proportion of participants who report unsolicited SAE.
Query!
Timepoint [10]
0
0
6 months post booster vaccination
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
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
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
2/05/2022
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
30/11/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
13
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Royal Children's Hospital - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
3010 - Melbourne
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Murdoch Childrens Research Institute
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Coalition for Epidemic Preparedness Innovations
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
The Peter Doherty Institute for Infection and Immunity
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Ethics approval
Ethics application status
Query!
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
Query!
Trial website
https://clinicaltrials.gov/study/NCT05228730
Query!
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. doi: 10.1016/S0140-6736(21)02785-9.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Kim Mulholland, MD
Query!
Address
0
0
Murdoch Childrens Research Institute
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
We will share de-identified data to ethically approved studies in cases where participants have indicated on the consent form that they consent to the use of their data and where consistent with terms of collaboration agreements.
Supporting document/s available: Study protocol, Informed consent form (ICF)
Query!
When will data be available (start and end dates)?
Individual participant data (IPD) sharing plans in development
Query!
Available to whom?
IPD sharing plans in development
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05228730