Trial Outcomes & Findings for Evaluation of Full Versus Fractional Doses of COVID-19 Vaccines Given as a Booster in Adults in Australia - Mongolia, Indonesia, Australia Coronavirus (MIACoV). (NCT NCT05228730)
NCT ID: NCT05228730
Last Updated: 2024-12-16
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
13 participants
Primary outcome timeframe
28-days post booster vaccination.
Results posted on
2024-12-16
Participant Flow
Participants who met the inclusion criteria and none of the exclusion criteria were randomised and assigned to one of the eight groups. However, due to the small number of participants enrolled, we have combined the groups based on the vaccine they received during the study and not stratify based on their previous vaccination history.
Participant milestones
| Measure |
Standard Pfizer-BioNTech Booster Group
Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine
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.
|
Fractional Pfizer-BioNTech Booster Group
Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine
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.
|
Standard Elasomeran Booster Group
Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine
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.
|
Fractional Elasomeran Booster Group
Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
1
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
1
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Full Versus Fractional Doses of COVID-19 Vaccines Given as a Booster in Adults in Australia - Mongolia, Indonesia, Australia Coronavirus (MIACoV).
Baseline characteristics by cohort
| Measure |
Standard Pfizer-BioNTech Booster Group
n=4 Participants
Due to the small number of participants enrolled, we have combined the groups based on the vaccine they received (i.e. Standard Pfizer-BioNTech booster group) and did not stratify based on their previous vaccination history (i.e. received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine).
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.
|
Fractional Pfizer-BioNTech Booster Group
n=1 Participants
Due to the small number of participants enrolled, we have combined the groups based on the vaccine they received (i.e. fractional Pfizer-BioNTech booster group) and did not stratify based on their previous vaccination history (i.e. received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine).
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.
|
Standard Elasomeran Booster Group
n=4 Participants
Due to the small number of participants enrolled, we have combined the groups based on the vaccine they received (i.e. standard Elasomeran booster group) and did not stratify based on their previous vaccination history (i.e. received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine).
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.
|
Fractional Elasomeran Booster Group
n=4 Participants
Due to the small number of participants enrolled, we have combined the groups based on the vaccine they received (i.e. fractional Elasomeran booster group) and did not stratify based on their previous vaccination history (i.e. received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine).
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.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Age
|
55.23 years
n=5 Participants
|
33.5 years
n=7 Participants
|
44.7 years
n=5 Participants
|
40.6 years
n=4 Participants
|
44.7 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Australian
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
8 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Filipino
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Korean
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Polish
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Serbian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Southern and East African
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Region of Enrollment
Australia
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
13 participants
n=21 Participants
|
|
Any reaction to primary vaccine
Yes
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Any reaction to primary vaccine
No
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Medical status at enrolment
*Gestational diabetes (female only)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Medical status at enrolment
*Pregnant (female only)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Medical status at enrolment
Cardiovascular disease
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Medical status at enrolment
Cigarette use
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Medical status at enrolment
Anticoagulant therapy
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Currently taking medication
No
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Currently taking medication
Yes
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ever tested positive to SARS-CoV-2
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Symptoms consistent with COVID-19
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Worst clinical spectrum of COVID-19
Mild
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Worst clinical spectrum of COVID-19
Moderate
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
BMI
|
25.5 kg/m2
n=5 Participants
|
21.9 kg/m2
n=7 Participants
|
27.8 kg/m2
n=5 Participants
|
23.0 kg/m2
n=4 Participants
|
24.4 kg/m2
n=21 Participants
|
|
Temperature
|
36.3 celsius
n=5 Participants
|
36.2 celsius
n=7 Participants
|
35.9 celsius
n=5 Participants
|
35.5 celsius
n=4 Participants
|
35.7 celsius
n=21 Participants
|
|
Pulse rate pre COVID-19 booster dose
|
75 beats/min
n=5 Participants
|
66 beats/min
n=7 Participants
|
66 beats/min
n=5 Participants
|
71 beats/min
n=4 Participants
|
67 beats/min
n=21 Participants
|
|
Respiratory rate pre COVID-19 booster dose
|
17 breaths/min
n=5 Participants
|
20 breaths/min
n=7 Participants
|
14 breaths/min
n=5 Participants
|
15 breaths/min
n=4 Participants
|
16 breaths/min
n=21 Participants
|
|
Blood pressure pre- COVID-19 booster dose
Systolic
|
125 mmHG
n=5 Participants
|
111 mmHG
n=7 Participants
|
119.5 mmHG
n=5 Participants
|
108 mmHG
n=4 Participants
|
111 mmHG
n=21 Participants
|
|
Blood pressure pre- COVID-19 booster dose
Diastolic
|
83 mmHG
n=5 Participants
|
76 mmHG
n=7 Participants
|
75 mmHG
n=5 Participants
|
73.5 mmHG
n=4 Participants
|
76 mmHG
n=21 Participants
|
PRIMARY outcome
Timeframe: 28-days post booster vaccination.Population: IgG antibody response 28-days post booster
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
Outcome measures
| Measure |
Standard Pfizer-BioNTech Booster Group
n=4 Participants
Due to the small enrolment numbers in each group, we have combined the groups based on the vaccine that they received (Standard Pfizer-BioNTech) instead of stratifying the groups based on their previous vaccines received e.g. AstraZeneca or Pfizer).
|
Fractional Pfizer-BioNTech Booster Group
n=1 Participants
Due to the small enrolment numbers in each group, we have combined the groups based on the vaccine that they received (Fractional Pfizer-BioNTech) instead of stratifying the groups based on their previous vaccines received e.g. AstraZeneca or Pfizer).
|
Standard Elasomeran Booster Group
n=4 Participants
Due to the small enrolment numbers in each group, we have combined the groups based on the vaccine that they received (Standard Elasomeran) instead of stratifying the groups based on their previous vaccines received e.g. AstraZeneca or Pfizer).
|
Fractional Elasomeran Booster Group
n=4 Participants
Due to the small enrolment numbers in each group, we have combined the groups based on the vaccine that they received (Fractional Elasomeran) instead of stratifying the groups based on their previous vaccines received e.g. AstraZeneca or Pfizer).
|
|---|---|---|---|---|
|
SARS-CoV-2 Specific Immunoglobulin (Ig)G Antibodies at 28-days Post Booster Vaccination
|
1927.1 binding antibody units (BAU/mL)
Interval 1665.4 to 3043.5
|
13707.2 binding antibody units (BAU/mL)
Interval 13707.2 to 13707.2
|
5118.6 binding antibody units (BAU/mL)
Interval 3837.6 to 8756.9
|
5908.7 binding antibody units (BAU/mL)
Interval 4926.0 to 6741.3
|
Adverse Events
Standard Pfizer-BioNTech Booster Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Fractional Pfizer-BioNTech Booster Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Elasomeran Booster Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Fractional Elasomeran Booster Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Pfizer-BioNTech Booster Group
n=4 participants at risk
Due to the low enrolment numbers, the groups were combined based on the vaccine they received (Standard Pfizer-BioNTech) and not stratified based on their vaccination history (AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine).
|
Fractional Pfizer-BioNTech Booster Group
n=1 participants at risk
Due to the low enrolment numbers, the groups were combined based on the vaccine they received (Fractional Pfizer-BioNTech) and not stratified based on their vaccination history (AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine).
|
Standard Elasomeran Booster Group
n=4 participants at risk
Due to the low enrolment numbers, the groups were combined based on the vaccine they received (Standard Elasomeran) and not stratified based on their vaccination history (AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine).
|
Fractional Elasomeran Booster Group
n=4 participants at risk
Due to the low enrolment numbers, the groups were combined based on the vaccine they received (Fractional Elasomeran) and not stratified based on their vaccination history (AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine).
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Throat infection
|
0.00%
0/4 • 7 days post vaccination
Any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and does not necessarily have a causal relationship with this treatment.
|
0.00%
0/1 • 7 days post vaccination
Any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and does not necessarily have a causal relationship with this treatment.
|
25.0%
1/4 • Number of events 1 • 7 days post vaccination
Any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • 7 days post vaccination
Any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and does not necessarily have a causal relationship with this treatment.
|
|
Investigations
Tiredness
|
25.0%
1/4 • Number of events 1 • 7 days post vaccination
Any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and does not necessarily have a causal relationship with this treatment.
|
0.00%
0/1 • 7 days post vaccination
Any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • 7 days post vaccination
Any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and does not necessarily have a causal relationship with this treatment.
|
0.00%
0/4 • 7 days post vaccination
Any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and does not necessarily have a causal relationship with this treatment.
|
Additional Information
Ms Kathryn Bright
Murdoch Children's Research Institute
Phone: +61 3 99366656
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place