Trial Outcomes & Findings for DMID 21-0041; Influenza CVD 59000 (NCT NCT05666245)
NCT ID: NCT05666245
Last Updated: 2025-08-26
Results Overview
Proportion of recipients with viral confirmation of influenza infection
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
2 weeks
Results posted on
2025-08-26
Participant Flow
Participant milestones
| Measure |
Donors
Donors are persons naturally infected with influenza.
|
Control Recipients
Control recipients are participants who do not have influenza and will not be using personal protective equipment.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
28
|
|
Overall Study
COMPLETED
|
6
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DMID 21-0041; Influenza CVD 59000
Baseline characteristics by cohort
| Measure |
Donors
n=6 Participants
Donors are persons naturally infected with influenza.
|
Control Recipients
n=28 Participants
Control recipients are participants who do not have influenza and will not be using personal protective equipment.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Nasal Swab
|
6 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Influenza Symptoms Score
|
6 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Serum HAI and FRNT antibody titers
|
6 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: A total of 28 Recipients (all under control conditions) were exposed to a total of 6 Donors.
Proportion of recipients with viral confirmation of influenza infection
Outcome measures
| Measure |
Donors
n=6 Participants
Donors are persons naturally infected with influenza.
|
Control Recipients
n=28 Participants
Control recipients are participants who do not have influenza and will not be using personal protective equipment.
|
|---|---|---|
|
Viral Confirmation
|
6 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: A total of 28 Recipients (all under control conditions) were exposed to a total of 6 Donors.
Proportion of recipients with symptomatic confirmation of influenza infection
Outcome measures
| Measure |
Donors
n=6 Participants
Donors are persons naturally infected with influenza.
|
Control Recipients
n=28 Participants
Control recipients are participants who do not have influenza and will not be using personal protective equipment.
|
|---|---|---|
|
Symptomatic Confirmation
|
6 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: A total of 28 Recipients (all under control conditions) were exposed to a total of 6 Donors.
Proportion of recipients with serological confirmation of influenza infection
Outcome measures
| Measure |
Donors
n=6 Participants
Donors are persons naturally infected with influenza.
|
Control Recipients
n=28 Participants
Control recipients are participants who do not have influenza and will not be using personal protective equipment.
|
|---|---|---|
|
Serological Confirmation
|
6 Participants
|
0 Participants
|
Adverse Events
Donors
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control Recipients
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Donors
n=6 participants at risk
Donors are persons naturally infected with influenza.
|
Control Recipients
n=28 participants at risk
Control recipients are participants who do not have influenza and will not be using personal protective equipment.
|
|---|---|---|
|
Cardiac disorders
Tachycardia
|
16.7%
1/6 • Number of events 1 • From enrollment until end of follow-up, 12 weeks
|
10.7%
3/28 • Number of events 3 • From enrollment until end of follow-up, 12 weeks
|
|
Cardiac disorders
Hypertension
|
0.00%
0/6 • From enrollment until end of follow-up, 12 weeks
|
25.0%
7/28 • Number of events 7 • From enrollment until end of follow-up, 12 weeks
|
Additional Information
Wilbur Chen, MD, MS
Center for Vaccine Development and Global Health (CVD)
Phone: 410-706-5328
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place