Trial Outcomes & Findings for Vaccination for Recovered Inpatients With COVID-19 (VATICO) (NCT NCT04969250)
NCT ID: NCT04969250
Last Updated: 2024-03-27
Results Overview
Change in antibody level as measured by ratio of follow-up to baseline level
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
66 participants
Primary outcome timeframe
Pre-vaccination baseline and 48 weeks post-vaccination
Results posted on
2024-03-27
Participant Flow
The number of participants consented was not collected, so these numbers are the number of participants randomized.
Participant milestones
| Measure |
Group I1
Immediate, one dose. Vaccination at study entry
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group I2
Immediate, two doses. Vaccination at study entry and Week 4
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group D1
Deferred, one dose. Vaccination at Week 12 only
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group D2
Deferred, two doses. Vaccination at Week 12 and Week 16
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
18
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
15
|
13
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
3
|
8
|
Reasons for withdrawal
| Measure |
Group I1
Immediate, one dose. Vaccination at study entry
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group I2
Immediate, two doses. Vaccination at study entry and Week 4
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group D1
Deferred, one dose. Vaccination at Week 12 only
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group D2
Deferred, two doses. Vaccination at Week 12 and Week 16
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
2
|
3
|
8
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Vaccination for Recovered Inpatients With COVID-19 (VATICO)
Baseline characteristics by cohort
| Measure |
Group I1
n=16 Participants
Immediate, one dose. Vaccination at study entry
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group I2
n=18 Participants
Immediate, two doses. Vaccination at study entry and Week 4
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group D1
n=16 Participants
Deferred, one dose. Vaccination at Week 12 only
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group D2
n=16 Participants
Deferred, two doses. Vaccination at Week 12 and Week 16
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native American Indian or Alaska Native
|
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
|
|
Race/Ethnicity, Customized
Asian
|
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
Native Hawaiian or Pacific Islander
|
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
|
|
Race/Ethnicity, Customized
Black or African American
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Only ethnicity reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Pre-vaccination baseline and 48 weeks post-vaccinationPopulation: Patient counts for this analysis are less than the total number of patients followed because some patients with follow-up visits did not have blood drawn.
Change in antibody level as measured by ratio of follow-up to baseline level
Outcome measures
| Measure |
Group I1
n=12 Participants
Immediate, one dose. Vaccination at study entry
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group I2
n=15 Participants
Immediate, two doses. Vaccination at study entry and Week 4
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group D1
n=13 Participants
Deferred, one dose. Vaccination at Week 12 only
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group D2
n=11 Participants
Deferred, two doses. Vaccination at Week 12 and Week 16
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
|---|---|---|---|---|
|
Ratio of 48-Week to Baseline Neutralizing Antibody (NAb) Levels
|
0.3722 ratio of geometric mean responses
Interval -0.0566 to 0.8012
|
0.5883 ratio of geometric mean responses
Interval 0.1366 to 1.0399
|
0.2088 ratio of geometric mean responses
Interval -0.1758 to 0.5935
|
0.3073 ratio of geometric mean responses
Interval -0.1479 to 0.7624
|
SECONDARY outcome
Timeframe: Pre-vaccination baseline and 12 weeks post-vaccinationPopulation: Patient counts for this analysis are less than the total number of patients followed because some patients with follow-up visits did not have blood drawn.
Change in antibody level as measured by ratio of follow-up to baseline level
Outcome measures
| Measure |
Group I1
n=13 Participants
Immediate, one dose. Vaccination at study entry
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group I2
n=15 Participants
Immediate, two doses. Vaccination at study entry and Week 4
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group D1
n=14 Participants
Deferred, one dose. Vaccination at Week 12 only
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group D2
n=13 Participants
Deferred, two doses. Vaccination at Week 12 and Week 16
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
|---|---|---|---|---|
|
Ratio of 12-Week to Baseline Neutralizing Antibody (NAb) Levels
|
0.4827 Ratio of geometric mean responses
Interval 0.0641 to 0.9014
|
0.9206 Ratio of geometric mean responses
Interval 0.4938 to 1.3474
|
0.2418 Ratio of geometric mean responses
Interval -0.1329 to 0.6165
|
0.6533 Ratio of geometric mean responses
Interval 0.1554 to 1.1513
|
SECONDARY outcome
Timeframe: Pre-vaccination baseline and 24 weeks post-vaccinationPopulation: Patient counts for this analysis are less than the total number of patients followed because some patients with follow-up visits did not have blood drawn.
Change in antibody level as measured by ratio of follow-up to baseline level
Outcome measures
| Measure |
Group I1
n=14 Participants
Immediate, one dose. Vaccination at study entry
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group I2
n=16 Participants
Immediate, two doses. Vaccination at study entry and Week 4
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group D1
n=14 Participants
Deferred, one dose. Vaccination at Week 12 only
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group D2
n=12 Participants
Deferred, two doses. Vaccination at Week 12 and Week 16
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
|---|---|---|---|---|
|
Ratio of 24-Week to Baseline Neutralizing Antibody (NAb) Levels
|
0.3002 Ratio of geometric mean responses
Interval -0.0453 to 0.6458
|
0.7747 Ratio of geometric mean responses
Interval 0.4187 to 1.1306
|
0.2032 Ratio of geometric mean responses
Interval -0.1265 to 0.5328
|
0.3397 Ratio of geometric mean responses
Interval -0.0498 to 0.7292
|
SECONDARY outcome
Timeframe: Through Week 24 after enrollmentPopulation: Participant who withdrew consent was not included in analysis. Used Fisher's exact test rather than Chi-squared due to small N.
Count of Deaths
Outcome measures
| Measure |
Group I1
n=16 Participants
Immediate, one dose. Vaccination at study entry
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group I2
n=17 Participants
Immediate, two doses. Vaccination at study entry and Week 4
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group D1
n=16 Participants
Deferred, one dose. Vaccination at Week 12 only
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group D2
n=16 Participants
Deferred, two doses. Vaccination at Week 12 and Week 16
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
|---|---|---|---|---|
|
Number of Deaths
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through Week 24Population: Participant who withdrew consent was not included in analysis. Used Fisher's exact test rather than Chi-squared due to small N.
Count of SAEs
Outcome measures
| Measure |
Group I1
n=16 Participants
Immediate, one dose. Vaccination at study entry
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group I2
n=17 Participants
Immediate, two doses. Vaccination at study entry and Week 4
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group D1
n=16 Participants
Deferred, one dose. Vaccination at Week 12 only
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group D2
n=16 Participants
Deferred, two doses. Vaccination at Week 12 and Week 16
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
|---|---|---|---|---|
|
Number of Serious Adverse Events (SAEs)
|
2 SAEs
|
0 SAEs
|
0 SAEs
|
1 SAEs
|
SECONDARY outcome
Timeframe: Second vaccine doses were due at 4 and 16 weeks after randomization in Arm 2 and 4, respectivelyPopulation: Participant who withdrew consent was not included in analysis. Used Fisher's exact test rather than Chi-squared due to small N.
Number of participants assigned a 2nd vaccine dose who did not receive it for any reason
Outcome measures
| Measure |
Group I1
n=17 Participants
Immediate, one dose. Vaccination at study entry
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group I2
n=16 Participants
Immediate, two doses. Vaccination at study entry and Week 4
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group D1
Deferred, one dose. Vaccination at Week 12 only
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group D2
Deferred, two doses. Vaccination at Week 12 and Week 16
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
|---|---|---|---|---|
|
Number of Patients Non-adherent to 2nd Dose
|
1 Participants
|
5 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Vaccine doses were due through 16-weeks post-randomization; participants were followed for vaccination status through 48 weeks post-randomizationPopulation: Participant who withdrew consent was not included in analysis. Used Fisher's exact test rather than Chi-squared due to small N.
Number of participants who received more or less vaccine than assigned, or who received vaccines at different time points than assigned
Outcome measures
| Measure |
Group I1
n=16 Participants
Immediate, one dose. Vaccination at study entry
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group I2
n=17 Participants
Immediate, two doses. Vaccination at study entry and Week 4
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group D1
n=16 Participants
Deferred, one dose. Vaccination at Week 12 only
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group D2
n=16 Participants
Deferred, two doses. Vaccination at Week 12 and Week 16
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
|---|---|---|---|---|
|
Number of Patients Non-adherent to Assigned Treatment Strategy
|
1 Participants
|
3 Participants
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Pre-vaccination baseline and 48 weeks post-vaccinationPopulation: Patient counts for this analysis are less than the total number of patients followed because some patients with follow-up visits did not have blood drawn.
Percentage of participants with \>=4-fold change in NAb from baseline to 48 weeks
Outcome measures
| Measure |
Group I1
n=12 Participants
Immediate, one dose. Vaccination at study entry
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group I2
n=15 Participants
Immediate, two doses. Vaccination at study entry and Week 4
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group D1
n=13 Participants
Deferred, one dose. Vaccination at Week 12 only
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group D2
n=11 Participants
Deferred, two doses. Vaccination at Week 12 and Week 16
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
|---|---|---|---|---|
|
Percent of Patients With >=4-fold Difference in NAb
|
41.70 percentage of participants
|
53.30 percentage of participants
|
30.80 percentage of participants
|
27.30 percentage of participants
|
Adverse Events
Group I1
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Group I2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group D1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group D2
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group I1
n=16 participants at risk
Immediate, one dose. Vaccination at study entry
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group I2
n=17 participants at risk
Immediate, two doses. Vaccination at study entry and Week 4
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group D1
n=16 participants at risk
Deferred, one dose. Vaccination at Week 12 only
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
Group D2
n=16 participants at risk
Deferred, two doses. Vaccination at Week 12 and Week 16
Moderna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection
Pfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection
|
|---|---|---|---|---|
|
General disorders
Acute chest pain
|
6.2%
1/16 • Number of events 1 • 48 weeks
Participant who withdrew consent was not included in analysis.
|
0.00%
0/17 • 48 weeks
Participant who withdrew consent was not included in analysis.
|
0.00%
0/16 • 48 weeks
Participant who withdrew consent was not included in analysis.
|
0.00%
0/16 • 48 weeks
Participant who withdrew consent was not included in analysis.
|
|
Blood and lymphatic system disorders
Aggravation of bicytopenia
|
6.2%
1/16 • Number of events 1 • 48 weeks
Participant who withdrew consent was not included in analysis.
|
0.00%
0/17 • 48 weeks
Participant who withdrew consent was not included in analysis.
|
0.00%
0/16 • 48 weeks
Participant who withdrew consent was not included in analysis.
|
0.00%
0/16 • 48 weeks
Participant who withdrew consent was not included in analysis.
|
|
Infections and infestations
Recurrence of COVID-19 infection
|
0.00%
0/16 • 48 weeks
Participant who withdrew consent was not included in analysis.
|
0.00%
0/17 • 48 weeks
Participant who withdrew consent was not included in analysis.
|
0.00%
0/16 • 48 weeks
Participant who withdrew consent was not included in analysis.
|
6.2%
1/16 • Number of events 1 • 48 weeks
Participant who withdrew consent was not included in analysis.
|
Other adverse events
Adverse event data not reported
Additional Information
Melissa Skeans, Statistician/Protocol Manager
University of Minnesota
Phone: 612-626-9011
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place