Trial Outcomes & Findings for KBP-201 COVID-19 Vaccine Trial in Healthy Volunteers (NCT NCT04473690)
NCT ID: NCT04473690
Last Updated: 2025-05-18
Results Overview
Occurrence of Adverse Events
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
102 participants
Primary outcome timeframe
7 days following the first vaccination on day 1 and 7 days following the second vaccination on day 22, up to 29 days
Results posted on
2025-05-18
Participant Flow
Participant milestones
| Measure |
Low Dose KBP-COVID-19 and Adjuvant
Two age groups.
Part A (18-49 years).
Part B (50-85 years).
All subjects in these groups will receive the low dose of KBP-COVID-19
Low Dose of KBP-COVID-19: Low Dose of KBP-COVID-19 and adjuvant
|
High Dose KBP-COVID-19 and Adjuvant
Two age groups.
Part A (18-49 years).
Part B (50-85 years).
All subjects in these groups will receive the high dose of KBP-COVID-19
High Dose of KBP-COVID-19: High Dose of KBP-COVID-19 and adjuvant
|
Placebo
Two age groups.
Part A (18-49 years).
Part B (50-85 years).
All subjects in these groups will receive placebo
Placebo: Buffered saline solution
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
30
|
36
|
|
Overall Study
COMPLETED
|
31
|
28
|
32
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
KBP-201 COVID-19 Vaccine Trial in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Low Dose KBP-COVID-19 and Adjuvant
n=36 Participants
Two age groups.
Part A (18-49 years).
Part B (50-85 years).
All subjects in these groups will receive the low dose of KBP-COVID-19
Low Dose of KBP-COVID-19: Low Dose of KBP-COVID-19 and adjuvant
|
High Dose KBP-COVID-19 and Adjuvant
n=30 Participants
Two age groups.
Part A (18-49 years).
Part B (50-85 years).
All subjects in these groups will receive the high dose of KBP-COVID-19
High Dose of KBP-COVID-19: High Dose of KBP-COVID-19 and adjuvant
|
Placebo
n=36 Participants
Two age groups.
Part A (18-49 years).
Part B (50-85 years).
All subjects in these groups will receive placebo
Placebo: Buffered saline solution
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
101 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
58 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
44 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
88 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 7 days following the first vaccination on day 1 and 7 days following the second vaccination on day 22, up to 29 daysPopulation: number of subjects with solicited site reactions 7 day after two vaccinations
Occurrence of Adverse Events
Outcome measures
| Measure |
Low Dose KBP-COVID-19 and Adjuvant
n=34 Participants
Two age groups.
Part A (18-49 years).
Part B (50-85 years).
All subjects in these groups will receive the low dose of KBP-COVID-19
Low Dose of KBP-COVID-19: Low Dose of KBP-COVID-19 and adjuvant
|
High Dose KBP-COVID-19 and Adjuvant
n=29 Participants
Two age groups.
Part A (18-49 years).
Part B (50-85 years).
All subjects in these groups will receive the high dose of KBP-COVID-19
High Dose of KBP-COVID-19: High Dose of KBP-COVID-19 and adjuvant
|
Placebo
n=35 Participants
Two age groups.
Part A (18-49 years).
Part B (50-85 years).
All subjects in these groups will receive placebo
Placebo: Buffered saline solution
|
|---|---|---|---|
|
Solicited Administration Site Reactions
|
19 participants
|
15 participants
|
20 participants
|
PRIMARY outcome
Timeframe: 7 days following the first vaccination on day 1 and 7 days following the second vaccination on day 22, up to 29 daysPopulation: Medically attended adverse reaction
Occurrence of Adverse Events
Outcome measures
| Measure |
Low Dose KBP-COVID-19 and Adjuvant
n=34 Participants
Two age groups.
Part A (18-49 years).
Part B (50-85 years).
All subjects in these groups will receive the low dose of KBP-COVID-19
Low Dose of KBP-COVID-19: Low Dose of KBP-COVID-19 and adjuvant
|
High Dose KBP-COVID-19 and Adjuvant
n=29 Participants
Two age groups.
Part A (18-49 years).
Part B (50-85 years).
All subjects in these groups will receive the high dose of KBP-COVID-19
High Dose of KBP-COVID-19: High Dose of KBP-COVID-19 and adjuvant
|
Placebo
n=35 Participants
Two age groups.
Part A (18-49 years).
Part B (50-85 years).
All subjects in these groups will receive placebo
Placebo: Buffered saline solution
|
|---|---|---|---|
|
Solicited Systemic Events
|
3 Number of events
|
2 Number of events
|
0 Number of events
|
Adverse Events
Low Dose KBP-COVID-19 and Adjuvant
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
High Dose KBP-COVID-19 and Adjuvant
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Dose KBP-COVID-19 and Adjuvant
n=36 participants at risk
Two age groups.
Part A (18-49 years).
Part B (50-85 years).
All subjects in these groups will receive the low dose of KBP-COVID-19
Low Dose of KBP-COVID-19: Low Dose of KBP-COVID-19 and adjuvant
|
High Dose KBP-COVID-19 and Adjuvant
n=30 participants at risk
Two age groups.
Part A (18-49 years).
Part B (50-85 years).
All subjects in these groups will receive the high dose of KBP-COVID-19
High Dose of KBP-COVID-19: High Dose of KBP-COVID-19 and adjuvant
|
Placebo
n=36 participants at risk
Two age groups.
Part A (18-49 years).
Part B (50-85 years).
All subjects in these groups will receive placebo
Placebo: Buffered saline solution
|
|---|---|---|---|
|
Investigations
Injection site reactions
|
13.9%
5/36 • Number of events 6 • From dosing to Day 43
|
13.3%
4/30 • Number of events 5 • From dosing to Day 43
|
8.3%
3/36 • Number of events 8 • From dosing to Day 43
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place