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

NCT ID: NCT05228730

Last Updated: 2024-12-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-02

Study Completion Date

2022-11-30

Brief Summary

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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

Detailed Description

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As per brief summary

Conditions

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COVID-19

Keywords

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Booster dose Moderna Pfizer fractional and standard doses COVID-19 vaccination mRNA vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The participants and those evaluating reactogenicity will be blinded to the vaccine allocation for the first 28 days following vaccination. After that, both clinical investigators and participants will be aware of their investigational product allocation. Laboratory staff will remain blinded to the investigational product allocation during the immunology testing.

Study Groups

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Standard Pfizer-BioNTech booster group

Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine

Group Type ACTIVE_COMPARATOR

Tozinameran - Standard dose

Intervention Type BIOLOGICAL

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.

Fractional Pfizer-BioNTech booster group

Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine

Group Type EXPERIMENTAL

Tozinameran - fractional dose

Intervention Type BIOLOGICAL

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.

Standard Elasomeran booster group

Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine

Group Type ACTIVE_COMPARATOR

Elasomeran - standard dose

Intervention Type BIOLOGICAL

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.

Fractional Elasomeran booster group

Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine

Group Type EXPERIMENTAL

Elasomeran - fractional dose

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

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.

Intervention Type BIOLOGICAL

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.

Intervention Type BIOLOGICAL

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 Type BIOLOGICAL

Other Intervention Names

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BNT162b2 Pfizer-BioNTech Comirnaty BNT162b2 Comirnaty Pfizer-BioNTech mRNA-1273 Spikevax Moderna mRNA-1273 Spikevax Moderna

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Coalition for Epidemic Preparedness Innovations

OTHER

Sponsor Role collaborator

The Peter Doherty Institute for Infection and Immunity

OTHER

Sponsor Role collaborator

Murdoch Childrens Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kim Mulholland, MD

Role: PRINCIPAL_INVESTIGATOR

Murdoch Childrens Research Institute

Locations

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Royal Children's Hospital

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type BACKGROUND
PMID: 34863358 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://www.nature.com/articles/d41586-021-01893-0

Quarter-dose of Moderna COVID vaccine still rouses a big immune response

https://www.fda.gov/media/73679/download

US Food and Drug Administration (FDA). Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials 2007

Other Identifiers

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81764

Identifier Type: -

Identifier Source: org_study_id