Trial Outcomes & Findings for VAccination to Improve Clinical outComes in Heart Failure Trial: a Feasibility Study (VACC-HeFT) (NCT NCT02268500)
NCT ID: NCT02268500
Last Updated: 2021-06-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
48 participants
Primary outcome timeframe
4 weeks
Results posted on
2021-06-09
Participant Flow
Participant milestones
| Measure |
Standard Dose Influenza Vaccine
Standard dose (45ug) influenza vaccine will be administered intramuscularly
Influenza vaccine: Influenza vaccine
|
High Dose Influenza Vaccine
High dose (180ug) influenza vaccine will be administered intramuscularly
Influenza vaccine: Influenza vaccine
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
VAccination to Improve Clinical outComes in Heart Failure Trial: a Feasibility Study (VACC-HeFT)
Baseline characteristics by cohort
| Measure |
Standard Dose Influenza Vaccine
n=24 Participants
Standard dose (45ug) influenza vaccine will be administered intramuscularly
Influenza vaccine: Influenza vaccine
|
High Dose Influenza Vaccine
n=24 Participants
High dose (180ug) influenza vaccine will be administered intramuscularly
Influenza vaccine: Influenza vaccine
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.4 years
STANDARD_DEVIATION 12.2 • n=99 Participants
|
62.5 years
STANDARD_DEVIATION 13.1 • n=107 Participants
|
59.45 years
STANDARD_DEVIATION 12.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Left Ventricular Ejection Fraction (LVEF) percentage
|
38.8 percentage of ejection fraction
STANDARD_DEVIATION 9.8 • n=99 Participants
|
40.3 percentage of ejection fraction
STANDARD_DEVIATION 10.2 • n=107 Participants
|
39.55 percentage of ejection fraction
STANDARD_DEVIATION 10 • n=206 Participants
|
|
Body mass index (BMI)
|
33.7 kg/m^2
STANDARD_DEVIATION 10 • n=99 Participants
|
30.9 kg/m^2
STANDARD_DEVIATION 6.8 • n=107 Participants
|
32.3 kg/m^2
STANDARD_DEVIATION 8.4 • n=206 Participants
|
|
number of current tobacco users
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Participants with Diabetes mellitus
|
4 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Participants with Atrial fibrillation
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Participants with Ischemic etiology
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Aspirin users
|
12 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) users
|
23 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Beta blocker users
|
22 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Mineralocorticoid Receptor Antagonists (MRA) users
|
17 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Diuretic users
|
20 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Long acting nitrate users
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Number of Digoxin users
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: 1 participant from 'standard dose influenza vaccine' arm and 1 participant from 'high dose influenza vaccine' arm were excluded as the sample was inadequate to run the assay.
Outcome measures
| Measure |
Standard Dose Influenza Vaccine
n=23 Participants
Standard dose (45ug) influenza vaccine will be administered intramuscularly
Influenza vaccine: Influenza vaccine
|
High Dose Influenza Vaccine
n=23 Participants
High dose (180ug) influenza vaccine will be administered intramuscularly
Influenza vaccine: Influenza vaccine
|
|---|---|---|
|
Number of Participants With 4 Fold Rise in Serum Antibody Concentration of A/H1N1 Vaccine Antigens
|
11 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: 1 participant from 'standard dose influenza vaccine' arm and 1 participant from 'high dose influenza vaccine' arm were excluded as the sample was inadequate to run the assay.
Outcome measures
| Measure |
Standard Dose Influenza Vaccine
n=23 Participants
Standard dose (45ug) influenza vaccine will be administered intramuscularly
Influenza vaccine: Influenza vaccine
|
High Dose Influenza Vaccine
n=23 Participants
High dose (180ug) influenza vaccine will be administered intramuscularly
Influenza vaccine: Influenza vaccine
|
|---|---|---|
|
Number of Participants With 4 Fold Rise in Serum Antibody Concentration of A/H3N2 Vaccine Antigens
|
15 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: 1 participant from 'standard dose influenza vaccine' arm and 1 participant from 'high dose influenza vaccine' arm were excluded as the sample was inadequate to run the assay.
Outcome measures
| Measure |
Standard Dose Influenza Vaccine
n=23 Participants
Standard dose (45ug) influenza vaccine will be administered intramuscularly
Influenza vaccine: Influenza vaccine
|
High Dose Influenza Vaccine
n=23 Participants
High dose (180ug) influenza vaccine will be administered intramuscularly
Influenza vaccine: Influenza vaccine
|
|---|---|---|
|
Number of Participants With 4 Fold Rise in Serum Antibody Concentration of B-type Vaccine Antigens
|
7 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 8 monthsInfluenza Like Illness is not considered adverse event.
Outcome measures
| Measure |
Standard Dose Influenza Vaccine
n=24 Participants
Standard dose (45ug) influenza vaccine will be administered intramuscularly
Influenza vaccine: Influenza vaccine
|
High Dose Influenza Vaccine
n=24 Participants
High dose (180ug) influenza vaccine will be administered intramuscularly
Influenza vaccine: Influenza vaccine
|
|---|---|---|
|
Number of Participants With Influenza Like Illness
|
8 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 8 monthsAll-cause hospitalizations are not considered adverse events.
Outcome measures
| Measure |
Standard Dose Influenza Vaccine
n=24 Participants
Standard dose (45ug) influenza vaccine will be administered intramuscularly
Influenza vaccine: Influenza vaccine
|
High Dose Influenza Vaccine
n=24 Participants
High dose (180ug) influenza vaccine will be administered intramuscularly
Influenza vaccine: Influenza vaccine
|
|---|---|---|
|
Number of All-cause Hospitalizations
|
15 hospitalizations
|
6 hospitalizations
|
Adverse Events
Standard Dose Influenza Vaccine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
High Dose Influenza Vaccine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Orly Vardeny, Associate Professor of Medicine
University of Minnesota
Phone: 612.467.4586
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place