Trial Outcomes & Findings for Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers (NCT NCT04588428)
NCT ID: NCT04588428
Last Updated: 2026-01-22
Results Overview
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with treatment. TEAEs: AEs with onset after administration of study medication through the end of the study, or any event that was present at baseline but worsened in intensity or was subsequently considered drug-related by the Investigator through the end of the study. TEAEs were graded based on the Toxicity Grading Scale for Healthy Adult \& Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Food and Drug Administration \[FDA\] Guidance for Industry), as Grade 1: No interference with activity, Grade 2: Some interference with activity, Grade 3: Prevents daily activity/requires medical intervention \& Grade 4: Emergency room visit/hospitalization. A causally related AE is one judged by the Investigator to have a possible, probable, or definite relationship to the administration of an investigational product (IP).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
192 participants
Primary outcome timeframe
From the first dose of the study drug up to the end of the study (up to 48.7 weeks)
Results posted on
2026-01-22
Participant Flow
Healthy adult volunteers were enrolled at 6 study sites between 21 June 2021 and 19 January 2023.
This study was planned for two parts i.e., Part 1 and Part 2. A total of 218 participants were screened for Part 1 of the study, out of which 192 participants were enrolled. Part 1 was to select the optimal dose for Part 2. However, none of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1. The data is reported only for Part 1.
Participant milestones
| Measure |
Part 1: INO-4700 Group A
Participants received one intradermal (ID) injection of 0.6 milligram (mg) of INO-4700 followed by electroporation (EP) using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group B
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group C
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group D
Participants received two ID injections (in an acceptable location on two different limbs) of 0.5 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group E
Participants received two ID injections (in an acceptable location on two different limbs) of 1.0 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group F
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group G
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group H
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group I
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
33
|
32
|
32
|
31
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
32
|
33
|
29
|
31
|
31
|
7
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
3
|
1
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1: INO-4700 Group A
Participants received one intradermal (ID) injection of 0.6 milligram (mg) of INO-4700 followed by electroporation (EP) using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group B
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group C
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group D
Participants received two ID injections (in an acceptable location on two different limbs) of 0.5 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group E
Participants received two ID injections (in an acceptable location on two different limbs) of 1.0 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group F
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group G
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group H
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group I
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Deviation
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Reason Not Specified
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Part 1: INO-4700 Group A
n=32 Participants
Participants received one ID injection of 0.6 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group B
n=33 Participants
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group C
n=32 Participants
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group D
n=32 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of 0.5 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group E
n=31 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of 1.0 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group F
n=8 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group G
n=8 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group H
n=8 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group I
n=8 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Total
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.4 years
STANDARD_DEVIATION 7.66 • n=270 Participants
|
34.2 years
STANDARD_DEVIATION 9.20 • n=4 Participants
|
34.8 years
STANDARD_DEVIATION 7.69 • n=9 Participants
|
31.5 years
STANDARD_DEVIATION 8.63 • n=220 Participants
|
35.0 years
STANDARD_DEVIATION 7.77 • n=3 Participants
|
28.4 years
STANDARD_DEVIATION 8.40 • n=18 Participants
|
34.0 years
STANDARD_DEVIATION 10.62 • n=2259 Participants
|
30.3 years
STANDARD_DEVIATION 7.52 • n=4 Participants
|
39.8 years
STANDARD_DEVIATION 6.96 • n=1 Participants
|
33.8 years
STANDARD_DEVIATION 8.37 • n=3 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=270 Participants
|
12 Participants
n=4 Participants
|
11 Participants
n=9 Participants
|
10 Participants
n=220 Participants
|
16 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
4 Participants
n=2259 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=1 Participants
|
68 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=270 Participants
|
21 Participants
n=4 Participants
|
21 Participants
n=9 Participants
|
22 Participants
n=220 Participants
|
15 Participants
n=3 Participants
|
8 Participants
n=18 Participants
|
4 Participants
n=2259 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=1 Participants
|
124 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=2259 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=2259 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=2259 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=270 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=9 Participants
|
2 Participants
n=220 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=2259 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=1 Participants
|
20 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=270 Participants
|
28 Participants
n=4 Participants
|
26 Participants
n=9 Participants
|
30 Participants
n=220 Participants
|
29 Participants
n=3 Participants
|
7 Participants
n=18 Participants
|
7 Participants
n=2259 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=1 Participants
|
172 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=2259 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=2259 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: From the first dose of the study drug up to the end of the study (up to 48.7 weeks)Population: The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. Percentages are rounded off to the nearest decimal point.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with treatment. TEAEs: AEs with onset after administration of study medication through the end of the study, or any event that was present at baseline but worsened in intensity or was subsequently considered drug-related by the Investigator through the end of the study. TEAEs were graded based on the Toxicity Grading Scale for Healthy Adult \& Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Food and Drug Administration \[FDA\] Guidance for Industry), as Grade 1: No interference with activity, Grade 2: Some interference with activity, Grade 3: Prevents daily activity/requires medical intervention \& Grade 4: Emergency room visit/hospitalization. A causally related AE is one judged by the Investigator to have a possible, probable, or definite relationship to the administration of an investigational product (IP).
Outcome measures
| Measure |
Part 1: INO-4700 Group C
n=32 Participants
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group A
n=32 Participants
Participants received one ID injection of 0.6 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group B
n=33 Participants
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group D
n=32 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of 0.5 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group E
n=31 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of 1.0 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group F
n=8 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group G
n=8 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group H
n=8 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group I
n=8 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Graded by Severity, and Treatment-related AEs
Percentage of Participants With TEAEs
|
43.8 percentage of participants
|
34.4 percentage of participants
|
30.3 percentage of participants
|
31.3 percentage of participants
|
41.9 percentage of participants
|
25.0 percentage of participants
|
75.0 percentage of participants
|
25.0 percentage of participants
|
50.0 percentage of participants
|
|
Part 1: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Graded by Severity, and Treatment-related AEs
Percentage of Participants With ≥ 1 Grade 1 TEAEs
|
28.1 percentage of participants
|
21.9 percentage of participants
|
24.2 percentage of participants
|
28.1 percentage of participants
|
32.3 percentage of participants
|
0.0 percentage of participants
|
50.0 percentage of participants
|
12.5 percentage of participants
|
25.0 percentage of participants
|
|
Part 1: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Graded by Severity, and Treatment-related AEs
Percentage of Participants With ≥ 1 Grade 2 TEAEs
|
28.1 percentage of participants
|
12.5 percentage of participants
|
12.1 percentage of participants
|
3.1 percentage of participants
|
12.9 percentage of participants
|
25.0 percentage of participants
|
50.0 percentage of participants
|
12.5 percentage of participants
|
25.0 percentage of participants
|
|
Part 1: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Graded by Severity, and Treatment-related AEs
Percentage of Participants With ≥ 1 Grade 3 TEAEs
|
6.3 percentage of participants
|
3.1 percentage of participants
|
0 percentage of participants
|
0.0 percentage of participants
|
3.2 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Part 1: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Graded by Severity, and Treatment-related AEs
Percentage of Participants With ≥ 1 Grade 4 TEAEs
|
3.1 percentage of participants
|
0.0 percentage of participants
|
3.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Part 1: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Graded by Severity, and Treatment-related AEs
Percentage of Participants With Treatment Related TEAEs
|
0.0 percentage of participants
|
3.1 percentage of participants
|
9.1 percentage of participants
|
6.3 percentage of participants
|
3.2 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
12.5 percentage of participants
|
PRIMARY outcome
Timeframe: From the first dose of the study drug up to the end of the study (up to 48.7 weeks)Population: The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. Percentages are rounded off to the nearest decimal point.
Reactions arising from the injectable product administration procedure were reported as injection site reactions. Injection site reactions were assessed in accordance with the 'Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials' FDA Guidance for Industry, September 2007. Local reactions to the injectable product such as pain, tenderness, erythema/redness, and induration/swelling were recorded. Injection site reactions were evaluated starting 30 minutes following the injection.
Outcome measures
| Measure |
Part 1: INO-4700 Group C
n=32 Participants
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group A
n=32 Participants
Participants received one ID injection of 0.6 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group B
n=33 Participants
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group D
n=32 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of 0.5 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group E
n=31 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of 1.0 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group F
n=8 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group G
n=8 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group H
n=8 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group I
n=8 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of Participants With Injection Site Reactions
Percentage of Participants With Injection Site Erythema
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
3.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Part 1: Percentage of Participants With Injection Site Reactions
Percentage of Participants With Injection Site Pruritis
|
0 percentage of participants
|
0 percentage of participants
|
3.0 percentage of participants
|
6.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: From Screening to the end of the study (up to 48.7 weeks)Population: The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. Percentage of participants are rounded off to the nearest decimal point.
An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Principal Investigator to the Sponsor can be appropriate.
Outcome measures
| Measure |
Part 1: INO-4700 Group C
n=32 Participants
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group A
n=32 Participants
Participants received one ID injection of 0.6 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group B
n=33 Participants
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group D
n=32 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of 0.5 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group E
n=31 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of 1.0 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group F
n=8 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group G
n=8 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group H
n=8 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group I
n=8 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of Participants With Adverse Events of Special Interest (AESIs)
|
3.1 percentage of participants
|
0 percentage of participants
|
6.1 percentage of participants
|
0 percentage of participants
|
6.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: At Week 6Population: The mITT population included all participants who received at least one dose of the INO-4700 or placebo. 'Overall number of participants analyzed" indicates the number of participants with data available for this outcome measure.
Whole blood and serum samples were collected for the cellular immunology assessment. MERS receptor binding domain (RBD) immunoglobulin G (IgG) concentrations in response to administration of INO-4700 in combination with EP were reported as the GMC.
Outcome measures
| Measure |
Part 1: INO-4700 Group C
n=33 Participants
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group A
n=32 Participants
Participants received one ID injection of 0.6 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group B
n=31 Participants
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group D
n=32 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of 0.5 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group E
n=31 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of 1.0 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group F
n=7 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group G
n=8 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group H
n=8 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group I
n=8 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Geometric Mean Concentration (GMC) of INO-4700 Antigen Specific Binding Antibody at Week 6
|
2.29 International Units per mL (IU/mL)
Interval 1.59 to 3.29
|
4.30 International Units per mL (IU/mL)
Interval 2.62 to 7.04
|
3.81 International Units per mL (IU/mL)
Interval 2.38 to 6.11
|
3.05 International Units per mL (IU/mL)
Interval 1.87 to 4.98
|
8.11 International Units per mL (IU/mL)
Interval 4.37 to 15.04
|
2.37 International Units per mL (IU/mL)
Interval 1.55 to 3.63
|
4.97 International Units per mL (IU/mL)
Interval 1.51 to 16.32
|
2.08 International Units per mL (IU/mL)
Interval 1.06 to 4.08
|
1.75 International Units per mL (IU/mL)
Interval 0.7 to 4.37
|
PRIMARY outcome
Timeframe: At Week 6Population: The mITT population included all participants who received at least one dose of the INO-4700 or placebo. 'Overall number of participants analyzed" indicates the number of participants with data available for this outcome measure.
Whole blood and serum samples were collected for the cellular immunology assessment. MERS RBD IgG concentrations in response to administration of INO-4700 in combination with EP were reported as the GMFR.
Outcome measures
| Measure |
Part 1: INO-4700 Group C
n=33 Participants
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group A
n=32 Participants
Participants received one ID injection of 0.6 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group B
n=31 Participants
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group D
n=32 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of 0.5 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group E
n=31 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of 1.0 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group F
n=7 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group G
n=8 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group H
n=8 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group I
n=8 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Geometric Mean Fold Rise (GMFR) of INO-4700 Antigen Specific Binding Antibody at Week 6
|
1.24 fold rise
Interval 1.01 to 1.52
|
1.93 fold rise
Interval 1.24 to 3.02
|
2.04 fold rise
Interval 1.31 to 3.18
|
1.40 fold rise
Interval 1.12 to 1.76
|
3.20 fold rise
Interval 1.93 to 5.29
|
1.10 fold rise
Interval 0.94 to 1.28
|
1.09 fold rise
Interval 0.93 to 1.28
|
1.30 fold rise
Interval 0.87 to 1.93
|
0.98 fold rise
Interval 0.92 to 1.06
|
PRIMARY outcome
Timeframe: At Week 10Population: The mITT population included all participants who received at least one dose of the INO-4700 or placebo. 'Overall number of participants analyzed" indicates the number of participants with data available for this outcome measure.
Whole blood and serum samples were collected for the cellular immunology assessment. MERS RBD IgG concentrations in response to administration of INO-4700 in combination with EP were reported as the GMC.
Outcome measures
| Measure |
Part 1: INO-4700 Group C
n=33 Participants
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group A
n=32 Participants
Participants received one ID injection of 0.6 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group B
n=31 Participants
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group D
n=32 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of 0.5 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group E
n=31 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of 1.0 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group F
n=7 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group G
n=8 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group H
n=8 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group I
n=8 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Geometric Mean Concentration (GMC) of INO-4700 Antigen Specific Binding Antibody at Week 10
|
3.49 International Units per mL (IU/mL)
Interval 2.07 to 5.9
|
5.07 International Units per mL (IU/mL)
Interval 3.09 to 8.32
|
6.68 International Units per mL (IU/mL)
Interval 3.8 to 11.72
|
7.33 International Units per mL (IU/mL)
Interval 3.56 to 15.09
|
11.92 International Units per mL (IU/mL)
Interval 6.02 to 23.58
|
1.99 International Units per mL (IU/mL)
Interval 1.36 to 2.92
|
5.36 International Units per mL (IU/mL)
Interval 1.88 to 15.25
|
1.84 International Units per mL (IU/mL)
Interval 0.94 to 3.6
|
1.68 International Units per mL (IU/mL)
Interval 0.62 to 4.52
|
PRIMARY outcome
Timeframe: At Week 10Population: The mITT population included all participants who received at least one dose of the INO-4700 or placebo. 'Overall number of participants analyzed" indicates the number of participants with data available for this outcome measure.
Whole blood and serum samples were collected for the cellular immunology assessment. MERS RBD IgG concentrations in response to administration of INO-4700 in combination with EP were reported as the GMFR.
Outcome measures
| Measure |
Part 1: INO-4700 Group C
n=33 Participants
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group A
n=32 Participants
Participants received one ID injection of 0.6 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group B
n=31 Participants
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group D
n=32 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of 0.5 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group E
n=31 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of 1.0 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group F
n=7 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group G
n=8 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group H
n=8 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group I
n=8 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Geometric Mean Fold Rise (GMFR) of INO-4700 Antigen Specific Binding Antibody at Week 10
|
1.88 fold rise
Interval 1.24 to 2.84
|
2.31 fold rise
Interval 1.52 to 3.5
|
3.60 fold rise
Interval 2.09 to 6.2
|
3.38 fold rise
Interval 1.88 to 6.05
|
4.69 fold rise
Interval 2.57 to 8.53
|
0.94 fold rise
Interval 0.84 to 1.05
|
1.22 fold rise
Interval 0.97 to 1.53
|
1.14 fold rise
Interval 0.82 to 1.58
|
0.95 fold rise
Interval 0.76 to 1.19
|
PRIMARY outcome
Timeframe: At Week 6Population: The mITT population included all participants who received at least one dose of the INO-4700 or placebo. 'Overall number of participants analyzed" indicates the number of participants with data available for this outcome measure.
The immune responses to INO-4700 were measured using assays that included a pseudovirus-based neutralization assay. Immunology blood samples were collected at serial time points. A MERS pseudovirus neutralizing antibody responder was defined as a participant with a sample post-treatment 50% inhibitory dose (ID50) that was \>20. Percentage responders were calculated based on number of responders at specified visit divided by number of participants evaluable at specified visit.
Outcome measures
| Measure |
Part 1: INO-4700 Group C
n=32 Participants
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group A
n=32 Participants
Participants received one ID injection of 0.6 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group B
n=31 Participants
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group D
n=32 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of 0.5 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group E
n=31 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of 1.0 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group F
n=7 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group G
n=8 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group H
n=8 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group I
n=8 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage Neutralizing Antibody Responders at Week 6
|
6.25 percentage of responders
|
12.50 percentage of responders
|
12.90 percentage of responders
|
6.25 percentage of responders
|
12.90 percentage of responders
|
0 percentage of responders
|
0 percentage of responders
|
0 percentage of responders
|
0 percentage of responders
|
PRIMARY outcome
Timeframe: At Week 10Population: The mITT population included all participants who received at least one dose of the INO-4700 or placebo. 'Overall number of participants analyzed" indicates the number of participants with data available for this outcome measure.
The immune responses to INO-4700 were measured using assays that included a pseudovirus-based neutralization assay. Immunology blood samples were collected at serial time points. A MERS pseudovirus neutralizing antibody responder was defined as a participant with a sample post-treatment 50% inhibitory dose (ID50) that was \>20. Percentage responders were calculated based on number of responders at specified visit divided by number of participants evaluable at specified visit.
Outcome measures
| Measure |
Part 1: INO-4700 Group C
n=33 Participants
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group A
n=32 Participants
Participants received one ID injection of 0.6 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group B
n=30 Participants
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group D
n=32 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of 0.5 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group E
n=31 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of 1.0 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group F
n=7 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group G
n=8 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group H
n=8 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group I
n=8 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage Neutralizing Antibody Responders at Week 10
|
9.09 percentage of responders
|
15.63 percentage of responders
|
10.00 percentage of responders
|
15.63 percentage of responders
|
12.90 percentage of responders
|
14.29 percentage of responders
|
0 percentage of responders
|
0 percentage of responders
|
0 percentage of responders
|
PRIMARY outcome
Timeframe: At Week 6Population: The mITT population included all participants who received at least one dose of the INO-4700 or placebo. 'Overall number of participants analyzed" indicates the number of participants with data available for this outcome measure.
Assessments of cellular immune responses to INO-4700 were performed using the immune response measured by interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) assay on peripheral blood mononuclear cells (PBMCs). A MERS spike ELISpot responder was defined as a participant with a post-treatment level that was \> baseline + 2 standard deviations of replicate. Percentage responders were calculated as on number of responders at specified visit divided by number of participants evaluable at specified visit.
Outcome measures
| Measure |
Part 1: INO-4700 Group C
n=26 Participants
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group A
n=28 Participants
Participants received one ID injection of 0.6 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group B
n=26 Participants
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group D
n=27 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of 0.5 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group E
n=25 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of 1.0 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group F
n=8 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group G
n=8 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group H
n=8 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group I
n=5 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of Antigen Specific Cellular Immune Responders at Week 6
|
0 percentage of responders
|
14.29 percentage of responders
|
11.54 percentage of responders
|
3.70 percentage of responders
|
24.00 percentage of responders
|
0 percentage of responders
|
0 percentage of responders
|
0 percentage of responders
|
20.00 percentage of responders
|
PRIMARY outcome
Timeframe: At Week 10Population: The mITT population included all participants who received at least one dose of the INO-4700 or placebo. 'Overall number of participants analyzed" indicates the number of participants with data available for this outcome measure.
Assessments of cellular immune responses to INO-4700 were performed using the immune response measured by interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) assay on peripheral blood mononuclear cells (PBMCs). A MERS spike ELISpot responder was defined as a participant with a post-treatment level that was \> baseline + 2 standard deviations of replicate. Percentage responders were calculated as on number of responders at specified visit divided by number of participants evaluable at specified visit.
Outcome measures
| Measure |
Part 1: INO-4700 Group C
n=26 Participants
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group A
n=31 Participants
Participants received one ID injection of 0.6 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group B
n=27 Participants
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group D
n=29 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of 0.5 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group E
n=29 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of 1.0 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group F
n=8 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group G
n=8 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group H
n=8 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group I
n=7 Participants
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of Antigen Specific Cellular Immune Responders at Week 10
|
23.08 percentage of responders
|
6.45 percentage of responders
|
7.41 percentage of responders
|
24.14 percentage of responders
|
17.24 percentage of responders
|
0 percentage of responders
|
0 percentage of responders
|
0 percentage of responders
|
14.29 percentage of responders
|
PRIMARY outcome
Timeframe: From the first dose of the study drug up to the end of the study (up to 68 weeks)Population: None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have causal relationship with treatment.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From the first dose of the study up to the end of the study (up to 68 weeks)Population: None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted.
Reactions arising from the injectable product administration procedure were reported as injection site reactions. Injection site reactions were assessed in accordance with the 'Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials' (FDA Guidance for Industry, September 2007). Local reactions to the injectable product such as pain, tenderness, erythema/redness, and induration/swelling were recorded. Injection site reactions were evaluated starting 30 minutes following the injection.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From Screening up to the end of the study (up to 68 weeks)Population: None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted.
An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Principal Investigator to the Sponsor can be appropriate. These included respiratory distress syndrome, pneumonia, neurologic, hematologic, immunologic, and other events (including local or systemic SAEs, acute renal failure, SARS-CoV-2 infection, or death). In addition, anxiety and pain related to the EP procedure were monitored.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At Week 12Population: None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted.
Whole blood and serum samples were collected for the cellular immunology assessment. MERS receptor binding domain (RBD) immunoglobulin G (IgG) concentrations in response to administration of INO-4700 in combination were to be assessed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At Week 12Population: None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted.
The immune responses to INO-4700 were to be measured using assays that included a pseudovirus-based neutralization assay. Immunology blood samples were to be collected at serial timepoints.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At Week 12Population: None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted.
Assessments of cellular immune responses to INO-4700 were to be performed using the immune response measured by interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) assay on peripheral blood mononuclear cells (PBMCs).
Outcome measures
Outcome data not reported
Adverse Events
Part 1: INO-4700 Group A
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1: INO-4700 Group B
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Part 1: INO-4700 Group C
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Part 1: INO-4700 Group D
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Part 1: INO-4700 Group E
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Part 1: Placebo Group F
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1: Placebo Group G
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1: Placebo Group H
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1: Placebo Group I
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: INO-4700 Group A
n=32 participants at risk
Participants received one ID injection of 0.6 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group B
n=33 participants at risk
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group C
n=32 participants at risk
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group D
n=32 participants at risk
Participants received two ID injections (in an acceptable location on two different limbs) of 0.5 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group E
n=31 participants at risk
Participants received two ID injections (in an acceptable location on two different limbs) of 1.0 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group F
n=8 participants at risk
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group G
n=8 participants at risk
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group H
n=8 participants at risk
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group I
n=8 participants at risk
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
3.0%
1/33 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/31 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/33 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
3.1%
1/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/31 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
Other adverse events
| Measure |
Part 1: INO-4700 Group A
n=32 participants at risk
Participants received one ID injection of 0.6 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group B
n=33 participants at risk
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: INO-4700 Group C
n=32 participants at risk
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group D
n=32 participants at risk
Participants received two ID injections (in an acceptable location on two different limbs) of 0.5 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: INO-4700 Group E
n=31 participants at risk
Participants received two ID injections (in an acceptable location on two different limbs) of 1.0 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group F
n=8 participants at risk
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
Part 1: Placebo Group G
n=8 participants at risk
Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group H
n=8 participants at risk
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
|
Part 1: Placebo Group I
n=8 participants at risk
Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/33 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
6.2%
2/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/31 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/33 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/31 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
12.5%
1/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
|
General disorders
Fatigue
|
6.2%
2/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
3.0%
1/33 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
3.1%
1/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/31 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
|
General disorders
Pyrexia
|
3.1%
1/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
3.0%
1/33 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
6.2%
2/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/31 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
|
General disorders
Injection site pruritus
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
3.0%
1/33 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
6.2%
2/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/31 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
|
Infections and infestations
COVID-19
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
6.1%
2/33 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
6.2%
2/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
3.2%
1/31 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
12.5%
1/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/33 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
6.2%
2/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
9.7%
3/31 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
12.5%
1/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
6.1%
2/33 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
9.4%
3/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/31 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
6.1%
2/33 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
6.2%
2/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/31 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
|
Infections and infestations
Malaria
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/33 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
6.2%
2/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/31 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/33 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/31 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
12.5%
1/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
|
Infections and infestations
Urethritis
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/33 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/31 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
12.5%
1/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
|
Investigations
Blood glucose increased
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
3.0%
1/33 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
12.5%
4/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
9.7%
3/31 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
12.5%
1/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
12.5%
1/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
|
Investigations
Aspartate aminotransferase increased
|
3.1%
1/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/33 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
6.2%
2/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/31 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
12.5%
1/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/33 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
6.2%
2/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
3.2%
1/31 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
12.5%
1/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
|
Investigations
Red blood cells urine
|
3.1%
1/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/33 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/31 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
12.5%
1/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
|
Investigations
Platelet count decreased
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/33 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/31 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
12.5%
1/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.2%
2/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
6.1%
2/33 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
9.4%
3/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
3.1%
1/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
6.5%
2/31 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
12.5%
1/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
12.5%
1/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/33 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
3.1%
1/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/31 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
12.5%
1/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/33 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/31 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
12.5%
1/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
|
Nervous system disorders
Headache
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
12.1%
4/33 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
3.1%
1/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
3.1%
1/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
6.5%
2/31 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
12.5%
1/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
12.5%
1/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
|
Psychiatric disorders
Depression
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/33 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/31 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
12.5%
1/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
|
Vascular disorders
Hypertension
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/33 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/32 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/31 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
12.5%
1/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
0.00%
0/8 • From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place