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

NCT05228730 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: 81764
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  28-days post booster vaccination.

Study Arms (4)

Standard Pfizer-BioNTech booster group

ACTIVE COMPARATOR

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

Biological: Tozinameran - Standard dose

Fractional Pfizer-BioNTech booster group

EXPERIMENTAL

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

Biological: Tozinameran - fractional dose

Standard Elasomeran booster group

ACTIVE COMPARATOR

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

Biological: Elasomeran - standard dose

Fractional Elasomeran booster group

EXPERIMENTAL

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

Biological: Elasomeran - fractional dose

Interventions

Tozinameran - Standard dose 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.

Also known as: BNT162b2, Pfizer-BioNTech, Comirnaty

Standard Pfizer-BioNTech booster group

Tozinameran - fractional dose 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.

Also known as: BNT162b2, Comirnaty, Pfizer-BioNTech

Fractional Pfizer-BioNTech booster group

Elasomeran - standard dose 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.

Also known as: mRNA-1273, Spikevax, Moderna

Standard Elasomeran booster group

Elasomeran - fractional dose 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.

Also known as: mRNA-1273, Spikevax, Moderna

Fractional Elasomeran booster group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead
• Coalition for Epidemic Preparedness Innovations: collaborator
• The Peter Doherty Institute for Infection and Immunity: collaborator

Study Sites (1)

Royal Children's Hospital

Melbourne, Victoria, 3010, Australia

Location

Related Publications (1)

• 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.

  PMID: 34863358 BACKGROUND

Related Links

• Quarter-dose of Moderna COVID vaccine still rouses a big immune response
• US Food and Drug Administration (FDA). Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials 2007

MeSH Terms

Conditions

COVID-19

Interventions

BNT162 Vaccine; 2019-nCoV Vaccine mRNA-1273

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Limitations and Caveats

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.

Results Point of Contact

• Title: Ms Kathryn Bright
• Organization: Murdoch Children's Research Institute

kathrynbright@mcri.edu.au

+61 3 99366656

Study Officials

• Kim Mulholland, MD

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 5, 2022
• First Posted: February 8, 2022
• Study Start: May 2, 2022
• Primary Completion: July 25, 2022
• Study Completion: November 30, 2022
• Last Updated: December 16, 2024
• Results First Posted: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Individual participant data (IPD) sharing plans in development
• Access Criteria: IPD sharing plans in development

Locations

AU (1)