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NCT05228730: MIACoV

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

Terminated Phase 3 Results posted Last updated 16 December 2024
What this trial tests

Phase 3 trial testing Tozinameran - Standard dose in COVID-19 in 13 participants. Terminated before completion.

Timeline
2 May 2022
Primary endpoint
25 July 2022
30 November 2022

Quick facts

Lead sponsorMurdoch Childrens Research Institute
PhasePhase 3
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment13
Start date2 May 2022
Primary completion25 July 2022
Estimated completion30 November 2022
Sites1 location across Australia

Drugs / interventions tested

Conditions studied

Sponsor

Murdoch Childrens Research Institute

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

GroupValue95% CI
Standard Pfizer-BioNTech Booster Group1927.11665.4 – 3043.5
Fractional Pfizer-BioNTech Booster Group13707.213707.2 – 13707.2
Standard Elasomeran Booster Group5118.63837.6 – 8756.9
Fractional Elasomeran Booster Group5908.74926 – 6741.3

Adverse events — posted to ClinicalTrials.gov

Time frame: 7 days post vaccination. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Standard Pfizer-BioNTech Booster Group
Serious: 0/4 (0%)
Deaths: 0/4
Fractional Pfizer-BioNTech Booster Group
Serious: 0/1 (0%)
Deaths: 0/1
Standard Elasomeran Booster Group
Serious: 0/4 (0%)
Deaths: 0/4
Fractional Elasomeran Booster Group
Serious: 0/4 (0%)
Deaths: 0/4
Other adverse events (2 terms — click to expand)

ReactionSystemStandard Pfizer-BioNTech B…Fractional Pfizer-BioNTech…Standard Elasomeran Booste…Fractional Elasomeran Boos…
Throat infectionRespiratory, thoracic and mediastinal disorders
TirednessInvestigations

Data from ClinicalTrials.gov NCT05228730 adverse events section.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Nanoparticles in clinical trials of COVID-19: An update.
    Rauf A, Abu-Izneid T, Khalil AA, Hafeez N, et al · · 2022 · cited 22× · PMID 35953020 · DOI 10.1016/j.ijsu.2022.106818
  2. An assessment of the strategy and status of COVID-19 vaccination in India.
    Gupta SL, Goswami S, Anand A, Naman N, et al · · 2023 · cited 5× · PMID 37041424 · DOI 10.1007/s12026-023-09373-5

Verify or expand the search:

Other recruiting trials for COVID-19

Currently open trials in the same condition.

Other Murdoch Childrens Research Institute trials

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Data sources for this page

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