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

Phase 3

Terminated

• Conditions: COVID-19
• Interventions: Biological: Tozinameran - Standard dose; Biological: Tozinameran - fractional dose; Biological: Elasomeran - standard dose; Biological: Elasomeran - fractional dose

• Registration Number: NCT05228730
• Lead Sponsor: Murdoch Childrens Research Institute

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

Detailed Description

As per brief summary

Study Timeline

• Study First Submitted: 2022-02-05
• Study First Submitted QC: 2022-02-05
• Study First Posted: 2022-02-08
• Study Start: 2022-05-02
• Primary Completion: 2022-07-25
• Study Completion: 2022-11-30
• Results First Submitted: 2024-04-20
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Results First Posted: 2024-12-16
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Pfizer-BioNTech booster group	Tozinameran - Standard dose	Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine
Fractional Pfizer-BioNTech booster group	Tozinameran - fractional dose	Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine
Standard Elasomeran booster group	Elasomeran - standard dose	Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine
Fractional Elasomeran booster group	Elasomeran - fractional dose	Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine

Primary Outcome Measures

Name	Time	Method
SARS-CoV-2 Specific Immunoglobulin (Ig)G Antibodies at 28-days Post Booster Vaccination	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

Trial Locations

Locations (1)

Royal Children's Hospital; 🇦🇺 Melbourne, Victoria, Australia