Trial Outcomes & Findings for CORVax12: SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine Trial for COVID-19 (SARS-CoV-2) (NCT NCT04627675)
NCT ID: NCT04627675
Last Updated: 2024-10-26
Results Overview
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Day 1
Results posted on
2024-10-26
Participant Flow
Study was terminated prematurely due to lack of efficacy. Per FDA guidance, enrolled patients were followed until Day 180 for safety.
Participant milestones
| Measure |
1A: Age 18-50; CORVax
Healthy volunteers age 18-50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
1B: Age 18-50; CORVax + pIL-12
Healthy volunteers age 18-50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
2A: Age > 50; CORVax
Healthy volunteers age \> 50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
2B: Age > 50; CORVax + pIL-12
Healthy volunteers age \> 50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
2
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CORVax12: SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine Trial for COVID-19 (SARS-CoV-2)
Baseline characteristics by cohort
| Measure |
1A: Age 18-50; CORVax
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
1B: Age 18-50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
2A: Age > 50; CORVax
n=2 Participants
Healthy volunteers age \> 50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
2B: Age > 50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age \> 50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
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
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
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 (NIH/OMB)
Asian
|
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 (NIH/OMB)
Native Hawaiian or Other 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
|
|
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
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Age, Categorical
>=65 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
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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 (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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 (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
11 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Study was terminated prematurely due to lack of efficacy. Per FDA guidance, enrolled patients were followed until Day 180 for safety.
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Outcome measures
| Measure |
1A: Age 18-50; CORVax
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
1B: Age 18-50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
2A: Age > 50; CORVax
n=2 Participants
Healthy volunteers age \> 50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
2B: Age > 50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age \> 50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events Occurring on Day 1
Grade 1
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 1
Grade 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 1
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 1
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 2Population: Study was terminated prematurely due to lack of efficacy. Per FDA guidance, enrolled patients were followed until Day 180 for safety.
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Outcome measures
| Measure |
1A: Age 18-50; CORVax
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
1B: Age 18-50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
2A: Age > 50; CORVax
n=2 Participants
Healthy volunteers age \> 50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
2B: Age > 50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age \> 50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events Occurring on Day 2
Grade 1
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 2
Grade 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 2
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 2
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 3Population: Study was terminated prematurely due to lack of efficacy. Per FDA guidance, enrolled patients were followed until Day 180 for safety.
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Outcome measures
| Measure |
1A: Age 18-50; CORVax
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
1B: Age 18-50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
2A: Age > 50; CORVax
n=2 Participants
Healthy volunteers age \> 50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
2B: Age > 50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age \> 50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events Occurring on Day 3
Grade 1
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 3
Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 3
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 3
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 15Population: Study was terminated prematurely due to lack of efficacy. Per FDA guidance, enrolled patients were followed until Day 180 for safety.
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Outcome measures
| Measure |
1A: Age 18-50; CORVax
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
1B: Age 18-50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
2A: Age > 50; CORVax
n=2 Participants
Healthy volunteers age \> 50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
2B: Age > 50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age \> 50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events Occurring on Day 15
Grade 1
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 15
Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 15
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 15
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 30Population: Study was terminated prematurely due to lack of efficacy. Per FDA guidance, enrolled patients were followed until Day 180 for safety.
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Outcome measures
| Measure |
1A: Age 18-50; CORVax
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
1B: Age 18-50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
2A: Age > 50; CORVax
n=2 Participants
Healthy volunteers age \> 50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
2B: Age > 50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age \> 50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events Occurring on Day 30
Grade 1
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 30
Grade 2
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 30
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 30
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 31Population: Study was terminated prematurely due to lack of efficacy. Per FDA guidance, enrolled patients were followed until Day 180 for safety.
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Outcome measures
| Measure |
1A: Age 18-50; CORVax
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
1B: Age 18-50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
2A: Age > 50; CORVax
n=2 Participants
Healthy volunteers age \> 50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
2B: Age > 50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age \> 50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events Occurring on Day 31
Grade 1
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 31
Grade 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 31
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 31
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 32Population: Study was terminated prematurely due to lack of efficacy. Per FDA guidance, enrolled patients were followed until Day 180 for safety.
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Outcome measures
| Measure |
1A: Age 18-50; CORVax
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
1B: Age 18-50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
2A: Age > 50; CORVax
n=2 Participants
Healthy volunteers age \> 50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
2B: Age > 50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age \> 50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events Occurring on Day 32
Grade 1
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 32
Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 32
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 32
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 45Population: Study was terminated prematurely due to lack of efficacy. Per FDA guidance, enrolled patients were followed until Day 180 for safety.
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Outcome measures
| Measure |
1A: Age 18-50; CORVax
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
1B: Age 18-50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
2A: Age > 50; CORVax
n=2 Participants
Healthy volunteers age \> 50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
2B: Age > 50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age \> 50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events Occurring on Day 45
Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 45
Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 45
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 45
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 60Population: Study was terminated prematurely due to lack of efficacy. Per FDA guidance, enrolled patients were followed until Day 180 for safety.
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Outcome measures
| Measure |
1A: Age 18-50; CORVax
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
1B: Age 18-50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
2A: Age > 50; CORVax
n=2 Participants
Healthy volunteers age \> 50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
2B: Age > 50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age \> 50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events Occurring on Day 60
Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 60
Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 60
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 60
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 90Population: Study was terminated prematurely due to lack of efficacy. Per FDA guidance, enrolled patients were followed until Day 180 for safety.
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Outcome measures
| Measure |
1A: Age 18-50; CORVax
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
1B: Age 18-50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
2A: Age > 50; CORVax
n=2 Participants
Healthy volunteers age \> 50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
2B: Age > 50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age \> 50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events Occurring on Day 90
Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 90
Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 90
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Occurring on Day 90
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 30Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs).
Outcome measures
| Measure |
1A: Age 18-50; CORVax
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
1B: Age 18-50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
2A: Age > 50; CORVax
n=2 Participants
Healthy volunteers age \> 50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
2B: Age > 50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age \> 50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
|---|---|---|---|---|
|
Medically Attended Adverse Events (MAAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 60Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs)
Outcome measures
| Measure |
1A: Age 18-50; CORVax
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
1B: Age 18-50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
2A: Age > 50; CORVax
n=2 Participants
Healthy volunteers age \> 50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
2B: Age > 50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age \> 50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
|---|---|---|---|---|
|
Medically Attended Adverse Events (MAAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 90Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs)
Outcome measures
| Measure |
1A: Age 18-50; CORVax
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
1B: Age 18-50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
2A: Age > 50; CORVax
n=2 Participants
Healthy volunteers age \> 50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
2B: Age > 50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age \> 50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
|---|---|---|---|---|
|
Medically Attended Adverse Events (MAAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Month 6Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs)
Outcome measures
| Measure |
1A: Age 18-50; CORVax
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
1B: Age 18-50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
2A: Age > 50; CORVax
n=2 Participants
Healthy volunteers age \> 50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
2B: Age > 50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age \> 50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
|---|---|---|---|---|
|
Medically Attended Adverse Events (MAAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Month 12Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs)
Outcome measures
| Measure |
1A: Age 18-50; CORVax
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
1B: Age 18-50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
2A: Age > 50; CORVax
n=2 Participants
Healthy volunteers age \> 50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
2B: Age > 50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age \> 50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
|---|---|---|---|---|
|
Medically Attended Adverse Events (MAAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Month 18Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs)
Outcome measures
| Measure |
1A: Age 18-50; CORVax
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
1B: Age 18-50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age 18-50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
2A: Age > 50; CORVax
n=2 Participants
Healthy volunteers age \> 50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
2B: Age > 50; CORVax + pIL-12
n=3 Participants
Healthy volunteers age \> 50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
|---|---|---|---|---|
|
Medically Attended Adverse Events (MAAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
1A: Age 18-50; CORVax
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
1B: Age 18-50; CORVax + pIL-12
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
2A: Age > 50; CORVax
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
2B: Age > 50; CORVax + pIL-12
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1A: Age 18-50; CORVax
n=3 participants at risk
Healthy volunteers age 18-50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
1B: Age 18-50; CORVax + pIL-12
n=3 participants at risk
Healthy volunteers age 18-50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
2A: Age > 50; CORVax
n=2 participants at risk
Healthy volunteers age \> 50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
2B: Age > 50; CORVax + pIL-12
n=3 participants at risk
Healthy volunteers age \> 50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
|---|---|---|---|---|
|
Investigations
Increased CPK
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
33.3%
1/3 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
Other adverse events
| Measure |
1A: Age 18-50; CORVax
n=3 participants at risk
Healthy volunteers age 18-50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
1B: Age 18-50; CORVax + pIL-12
n=3 participants at risk
Healthy volunteers age 18-50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
2A: Age > 50; CORVax
n=2 participants at risk
Healthy volunteers age \> 50 will receive CORVax
CORVax: DNA-encodable coronaviral vaccine
Cliniporator: electroporation system
|
2B: Age > 50; CORVax + pIL-12
n=3 participants at risk
Healthy volunteers age \> 50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
33.3%
1/3 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
33.3%
1/3 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
33.3%
1/3 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
General disorders
Chills
|
33.3%
1/3 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
33.3%
1/3 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
Investigations
Decreased hemoglobin
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
33.3%
1/3 • Number of events 2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
33.3%
1/3 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
33.3%
1/3 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
50.0%
1/2 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
Investigations
Elevated creatinine
|
33.3%
1/3 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
100.0%
3/3 • Number of events 3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
General disorders
Fever
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
33.3%
1/3 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
66.7%
2/3 • Number of events 3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
66.7%
2/3 • Number of events 2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
3/3 • Number of events 4 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
66.7%
2/3 • Number of events 3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
33.3%
1/3 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
Investigations
Increased BUN
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
33.3%
1/3 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
Investigations
Increased CPK
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
33.3%
1/3 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
33.3%
1/3 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
General disorders
Injection site redness
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
33.3%
1/3 • Number of events 2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
50.0%
1/2 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
General disorders
Injection site swelling
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
33.3%
1/3 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
50.0%
1/2 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
50.0%
1/2 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
33.3%
1/3 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
General disorders
Pain at electroporation site
|
66.7%
2/3 • Number of events 2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
33.3%
1/3 • Number of events 2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
General disorders
Pain at injection site
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
100.0%
3/3 • Number of events 3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
50.0%
1/2 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
Skin and subcutaneous tissue disorders
Pruritus at injection site
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
33.3%
1/3 • Number of events 2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
33.3%
1/3 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
Metabolism and nutrition disorders
Reduced appetite
|
33.3%
1/3 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
33.3%
1/3 • Number of events 1 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
33.3%
1/3 • Number of events 2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/2 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
0.00%
0/3 • For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place