COVID-19Phase 3MIACoVNCT05228730

Evaluation of Full Versus Fractional Doses of COVID-19 Vaccines Given as a Booster in Adults in Australia - Mongolia, Indonesia, Australia Coronavirus (MIACoV).

A Phase 3 study testing Tozinameran - Standard dose, Tozinameran - fractional dose and Elasomeran - standard dose in people with COVID-19, run by Murdoch Childrens Research Institute at 1 site in Australia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Tozinameran - Standard dose, Tozinameran - fractional dose and Elasomeran - standard dose
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteAustralia
Study dates: 2 May 2022to 30 Nov 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Have completed two doses of Pfizer-BioNTech or AstraZeneca vaccines with the recommended schedule 6 months prior to the date of enrolment
Willing and able to give written informed consent
Aged 18 years or above
Willing to complete the follow-up requirements of the study

Who cannot join

Received 3 doses of COVID-19 vaccine
Received 2 doses of COVID-19 less than 6 months prior to the start of the trial
Received a different Covid-19 vaccine not available in Australia
Currently on immunosuppressive medication or anti-cancer chemotherapy
HIV infection
Congenital immune deficiency syndrome

Show all 10Show fewer

Has received immunoglobulin or other blood products in the 3 months prior to vaccination
Study staff and their relatives
Have a history of a severe allergic reaction to any COVID-19 vaccines or have a medical exception to receiving further COVID-19 vaccines
Cannot read or understand English

Trial locations and contacts

1 site in 1 country.

Australia1 site

Royal Children's Hospital
Melbourne, Victoria, 3010

Other trials in Australia

About this study

Official 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

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

Read the detailed description

As per brief summary

Conditions: COVID-19
Being tested: Tozinameran - Standard dose, Tozinameran - fractional dose, Elasomeran - standard dose, Elasomeran - fractional dose
Keywords: Booster dose, Moderna, Pfizer, fractional and standard doses, COVID-19 vaccination, mRNA vaccine
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tozinameran - Standard doseBiological
Also called BNT162b2, Pfizer-BioNTech, Comirnaty
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.
Tozinameran - fractional doseBiological
Also called BNT162b2, Comirnaty, Pfizer-BioNTech
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.
Elasomeran - standard doseBiological
Also called mRNA-1273, Spikevax, Moderna
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.
Elasomeran - fractional doseBiological
Also called mRNA-1273, Spikevax, Moderna
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.

Study groups in NCT05228730
Study group	Role	What they receive
Standard Pfizer-BioNTech booster group	Active comparator	Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine Receives: Biological: Tozinameran - Standard dose
Fractional Pfizer-BioNTech booster group	Experimental	Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine Receives: Biological: Tozinameran - fractional dose
Standard Elasomeran booster group	Active comparator	Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine Receives: Biological: Elasomeran - standard dose
Fractional Elasomeran booster group	Experimental	Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine Receives: Biological: Elasomeran - fractional dose

What is being measured

The primary outcome is the main question the study is designed to answer.

SARS-CoV-2 Specific Immunoglobulin (Ig)G Antibodies at 28-days Post Booster Vaccination
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
Measured: 28-days post booster vaccination.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 May 202230 Nov 2022

First posted8 Feb 2022
Study start2 May 2022
Primary completion25 Jul 2022
Study completion30 Nov 2022

Why it stopped: Due to the small number of participants

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by Murdoch Childrens Research InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Study participants who have received two doses of either Pfizer or Astrazena vaccine as their primary vaccine will be randomised into one of four groups. The four groups consists of a standard or fractional dose of either Pfizer or Moderna vaccine.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05228730
Sponsor's protocol ID: 81764
Acronym: MIACoV
Status last verified: Dec 2024
First submitted: 5 Feb 2022
Last updated: 16 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

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.
PubMed 34863358

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT05228730
Acronym / sponsor ID: MIACoV / 81764
Conditions: COVID-19
Keywords: Booster dose, Moderna, Pfizer, fractional and standard doses, COVID-19 vaccination, mRNA vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to the small number of participants
Enrolment: 13 participants (actual)
Lead sponsor: Murdoch Childrens Research InstituteUniversity, hospital or other
Collaborators: Coalition for Epidemic Preparedness Innovations, The Peter Doherty Institute for Infection and Immunity
Study start: 2 May 2022 (actual)
Primary completion: 25 Jul 2022 (actual)
Study completion: 30 Nov 2022 (actual)
First posted: 8 Feb 2022 (actual)
Results: Posted 16 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

As per brief summary

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4
Model description: Study participants who have received two doses of either Pfizer or Astrazena vaccine as their primary vaccine will be randomised into one of four groups. The four groups consists of a standard or fractional dose of either Pfizer or Moderna vaccine.

Arm	Type	Receives
Standard Pfizer-BioNTech booster group	Active comparator	Biological: Tozinameran - Standard doseReceived two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine
Fractional Pfizer-BioNTech booster group	Experimental	Biological: Tozinameran - fractional doseReceived two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine
Standard Elasomeran booster group	Active comparator	Biological: Elasomeran - standard doseReceived two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine
Fractional Elasomeran booster group	Experimental	Biological: Elasomeran - fractional doseReceived two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Have completed two doses of Pfizer-BioNTech or AstraZeneca vaccines with the recommended schedule 6 months prior to the date of enrolment
Willing and able to give written informed consent
Aged 18 years or above
Willing to complete the follow-up requirements of the study

Key exclusion criteria (10 listed)

Received 3 doses of COVID-19 vaccine
Received 2 doses of COVID-19 less than 6 months prior to the start of the trial
Received a different Covid-19 vaccine not available in Australia
Currently on immunosuppressive medication or anti-cancer chemotherapy
HIV infection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tozinameran - Standard doseAlso: BNT162b2, Pfizer-BioNTech, ComirnatyTozinamrean 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.	Biological	Standard Pfizer-BioNTech booster group
Tozinameran - fractional doseAlso: BNT162b2, Comirnaty, Pfizer-BioNTechTozinamrean 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.	Biological	Fractional Pfizer-BioNTech booster group
Elasomeran - standard doseAlso: mRNA-1273, Spikevax, ModernaElasomeran 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.	Biological	Standard Elasomeran booster group
Elasomeran - fractional doseAlso: mRNA-1273, Spikevax, ModernaElasomeran 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.	Biological	Fractional Elasomeran booster group

Primary outcome

SARS-CoV-2 Specific Immunoglobulin (Ig)G Antibodies at 28-days Post Booster Vaccination
Time frame: 28-days post booster vaccination.
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

Results and safety

Results posted to the registry on 16 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Pfizer-BioNTech Booster Group	4	4
Fractional Pfizer-BioNTech Booster Group	1	1
Standard Elasomeran Booster Group	4	4
Fractional Elasomeran Booster Group	4	4

Primary outcome: SARS-CoV-2 Specific Immunoglobulin (Ig)G Antibodies at 28-days Post Booster Vaccination

Time frame: 28-days post booster vaccination.. Median (Inter-Quartile Range). Unit: binding antibody units (BAU/mL)

Measure	Standard Pfizer-BioNTech Booster Group n = 4	Fractional Pfizer-BioNTech Booster Group n = 1	Standard Elasomeran Booster Group n = 4	Fractional Elasomeran Booster Group n = 4
Value	1927.1 (1665.4 to 3043.5)	13707.2 (13707.2 to 13707.2)	5118.6 (3837.6 to 8756.9)	5908.7 (4926 to 6741.3)

Population analysed: IgG antibody response 28-days post booster

Adverse events

Time frame: 7 days post vaccination. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Pfizer-BioNTech Booster Group	0 of 4 (0%)	1 of 4 (25%)	0 of 4
Fractional Pfizer-BioNTech Booster Group	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Standard Elasomeran Booster Group	0 of 4 (0%)	1 of 4 (25%)	0 of 4
Fractional Elasomeran Booster Group	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Limitations and caveats (from the sponsor): Enrolment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 34863358Munro 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.
Quarter-dose of Moderna COVID vaccine still rouses a big immune responseLink provided by the sponsor.
US Food and Drug Administration (FDA). Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials 2007Link provided by the sponsor.
Australian Technical Advisory Group on Immunisation (ATAGI). ATAGI recommendations on the use of a booster dose of COVID-19 vaccine 2021Link provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kim Mulholland, MD principal investigator

Murdoch Childrens Research Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SARS-CoV-2 Specific Immunoglobulin (Ig)G Antibodies at 28-days Post Booster Vaccination (time frame: 28-days post booster vaccination.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05228730, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.