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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).
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
Treatment: Other - Tozinameran - Standard dose
Treatment: Other - Tozinameran - fractional dose
Treatment: Other - Elasomeran - standard dose
Treatment: Other - Elasomeran - fractional dose

Active comparator: Standard Pfizer-BioNTech booster group - Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine

Experimental: Fractional Pfizer-BioNTech booster group - Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine

Active comparator: Standard Elasomeran booster group - Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine

Experimental: Fractional Elasomeran booster group - Received two doses of AstraZeneca or 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.
Intervention code [1] 0 0
Treatment: Other
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
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
Timepoint [1] 0 0
28-days 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
Stopped early
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
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Coalition for Epidemic Preparedness Innovations
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The Peter Doherty Institute for Infection and Immunity
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol Study Protocol and Statistical Analysis Plan
Statistical analysis plan Study Protocol and Statistical Analysis Plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT05228730