Trial Outcomes & Findings for Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure (NCT NCT04642638)
NCT ID: NCT04642638
Last Updated: 2023-12-20
Results Overview
Whole blood and serum samples were collected for the cellular immunology assessment. The antigen-specific cellular immune response to INO-4800 was measured in spot-forming units per million peripheral blood mononuclear cells (SFU/10\^6, PBMC) using ELISpot. No samples collected after Week 6 were analyzed.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
1307 participants
Primary outcome timeframe
Baseline up to Week 6
Results posted on
2023-12-20
Participant Flow
For the phase 2 segment, participants were enrolled at 16 study sites in the United States. For the Phase 3 segment, participants were enrolled at 11 study sites in Colombia and Mexico. They were enrolled between 30 November 2020 to 13 September 2022
In the Phase 2 segment, 618 participants were screened, of which 401 participants were enrolled to receive INO-4800 or placebo. In the Phase 3 segment, 978 participants were screened, of which 906 participants were enrolled to receive INO-4800 or placebo.
Participant milestones
| Measure |
Phase 2: INO-4800 Dose Group 1
Participants received one intradermal (ID) injection of 1.0 milligram (mg) of INO-4800 followed by electroporation (EP) using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: INO-4800 Dose Group 2
Participants received 2 ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 1
Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 2
Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)
Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: Placebo Dose Group
Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
151
|
149
|
50
|
51
|
603
|
303
|
|
Overall Study
Intention-to-treat (ITT) Population
|
151
|
149
|
50
|
51
|
603
|
303
|
|
Overall Study
Per Protocol (PP) Population
|
141
|
130
|
47
|
48
|
507
|
261
|
|
Overall Study
Safety Population
|
151
|
147
|
50
|
51
|
601
|
302
|
|
Overall Study
COMPLETED
|
110
|
98
|
35
|
39
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
41
|
51
|
15
|
12
|
603
|
303
|
Reasons for withdrawal
| Measure |
Phase 2: INO-4800 Dose Group 1
Participants received one intradermal (ID) injection of 1.0 milligram (mg) of INO-4800 followed by electroporation (EP) using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: INO-4800 Dose Group 2
Participants received 2 ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 1
Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 2
Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)
Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: Placebo Dose Group
Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
23
|
29
|
9
|
7
|
61
|
27
|
|
Overall Study
Lost to Follow-up
|
17
|
18
|
5
|
5
|
6
|
3
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
10
|
3
|
|
Overall Study
Reason Not Specified
|
1
|
4
|
0
|
0
|
38
|
16
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
2
|
1
|
|
Overall Study
Protocol Deviation
|
0
|
0
|
0
|
0
|
1
|
3
|
|
Overall Study
Study Terminated
|
0
|
0
|
0
|
0
|
484
|
250
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure
Baseline characteristics by cohort
| Measure |
Phase 2: INO-4800 Dose Group 1
n=151 Participants
Participants received one ID injection of 1.0 mg of INO-4800 followed by electroporation (EP) using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: INO-4800 Dose Group 2
n=149 Participants
Participants received 2 ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 1
n=50 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 2
n=51 Participants
Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)
n=603 Participants
Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: Placebo Dose Group
n=303 Participants
Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Total
n=1307 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
Age · 18-50 years
|
98 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
533 Participants
n=21 Participants
|
267 Participants
n=8 Participants
|
1061 Participants
n=8 Participants
|
|
Age, Customized
Age · 51-64 years
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
200 Participants
n=8 Participants
|
|
Age, Customized
Age · >=65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
46 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
245 Participants
n=21 Participants
|
120 Participants
n=8 Participants
|
576 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
358 Participants
n=21 Participants
|
183 Participants
n=8 Participants
|
731 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
601 Participants
n=21 Participants
|
300 Participants
n=8 Participants
|
960 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
122 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
345 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
314 Participants
n=21 Participants
|
171 Participants
n=8 Participants
|
491 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
42 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
127 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
364 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
267 Participants
n=21 Participants
|
123 Participants
n=8 Participants
|
394 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 6Population: PP population included all participants who received all doses of the trial intervention and had no key protocol violations. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' denotes the number of participants available at individual timepoints.
Whole blood and serum samples were collected for the cellular immunology assessment. The antigen-specific cellular immune response to INO-4800 was measured in spot-forming units per million peripheral blood mononuclear cells (SFU/10\^6, PBMC) using ELISpot. No samples collected after Week 6 were analyzed.
Outcome measures
| Measure |
Phase 2: INO-4800 Dose Group 1
n=103 Participants
Participants received one ID injection of 1.0 mg of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: INO-4800 Dose Group 2
n=97 Participants
Participants received 2 ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 1
n=37 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 2
n=35 Participants
Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)
Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: Placebo Dose Group
Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
|---|---|---|---|---|---|---|
|
Phase 2: Change From Baseline in Antigen-specific Cellular Immune Response Measured by Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISpot) Assay
Baseline
|
0.00 SFU/10^6, PBMC
Interval 0.0 to 90.0
|
2.20 SFU/10^6, PBMC
Interval 0.0 to 115.6
|
0.00 SFU/10^6, PBMC
Interval 0.0 to 25.6
|
0.00 SFU/10^6, PBMC
Interval 0.0 to 95.6
|
—
|
—
|
|
Phase 2: Change From Baseline in Antigen-specific Cellular Immune Response Measured by Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISpot) Assay
Change From Baseline at Week 6
|
6.70 SFU/10^6, PBMC
Interval 0.0 to 245.6
|
13.30 SFU/10^6, PBMC
Interval 0.0 to 311.1
|
0.00 SFU/10^6, PBMC
Interval 0.0 to 81.1
|
0.00 SFU/10^6, PBMC
Interval 0.0 to 54.4
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Week 6Population: PP population included all participants who received all doses of the trial intervention and had no key protocol violations. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' denotes the number of participants available at individual timepoints.
The immune responses to INO-4800 were measured using assays that included a pseudovirus-based neutralization assay. Immunology blood samples were collected at serial timepoints. No samples collected after Week 6 were analyzed.
Outcome measures
| Measure |
Phase 2: INO-4800 Dose Group 1
n=133 Participants
Participants received one ID injection of 1.0 mg of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: INO-4800 Dose Group 2
n=120 Participants
Participants received 2 ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 1
n=47 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 2
n=45 Participants
Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)
Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: Placebo Dose Group
Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
|---|---|---|---|---|---|---|
|
Phase 2: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay
Baseline
|
34.8 inhibition dilution 50 (ID50)
Standard Deviation 0.42
|
40.6 inhibition dilution 50 (ID50)
Standard Deviation 0.52
|
30.2 inhibition dilution 50 (ID50)
Standard Deviation 0.40
|
38.0 inhibition dilution 50 (ID50)
Standard Deviation 0.45
|
—
|
—
|
|
Phase 2: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay
Change From Baseline at Week 6
|
3.1 inhibition dilution 50 (ID50)
Standard Deviation 0.49
|
4.6 inhibition dilution 50 (ID50)
Standard Deviation 0.52
|
1.2 inhibition dilution 50 (ID50)
Standard Deviation 0.39
|
1.2 inhibition dilution 50 (ID50)
Standard Deviation 0.49
|
—
|
—
|
PRIMARY outcome
Timeframe: From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126)Population: For the Phase 3 segment, as pre-specified in the protocol, an independent endpoint adjudication committee (EAC) was to review and confirm the suspected COVID-19 cases which fulfilled the definition for virologically-confirmed COVID-19 cases. As the trial was prematurely terminated, suspected COVID-19 cases were not reconciled with the EAC. Therefore, data that was planned for the EAC to reconcile was not available for efficacy analysis and data could not be reported for the outcome measure.
Participants were virologically-confirmed cases of COVID-19, if tested positive by SARS-CoV-2 RT-PCR assay, with symptoms like fever (temperature of 100.4ºF/38.0ºC or higher), chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting, diarrhoea. Participants with no prior exposure to COVID-19 at baseline were considered for the analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 days following each dose: Day 0 (Days 0 to Day 7) and Day 28 (Days 28 to Day 35)Population: Safety population included all participants who received at least one dose of the trial intervention.
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' (Food and Drug Administration \[FDA\] Guidance for Industry, September 2007). Participants were provided a diary to record the solicited injection site reactions. 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. The solicited injection site reactions were recorded for 7 days after each dose.
Outcome measures
| Measure |
Phase 2: INO-4800 Dose Group 1
n=151 Participants
Participants received one ID injection of 1.0 mg of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: INO-4800 Dose Group 2
n=147 Participants
Participants received 2 ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 1
n=50 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 2
n=51 Participants
Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)
n=601 Participants
Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: Placebo Dose Group
n=302 Participants
Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
|---|---|---|---|---|---|---|
|
Phase 2 and 3: Percentage of Participants With Solicited Injection Site Reactions
Injection Site Pain
|
27.2 percentage of participants
|
36.1 percentage of participants
|
20.0 percentage of participants
|
23.5 percentage of participants
|
19.1 percentage of participants
|
21.2 percentage of participants
|
|
Phase 2 and 3: Percentage of Participants With Solicited Injection Site Reactions
Injection Site Tenderness
|
1.9 percentage of participants
|
5.4 percentage of participants
|
2.0 percentage of participants
|
3.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Phase 2 and 3: Percentage of Participants With Solicited Injection Site Reactions
Injection Site Erythema
|
17.9 percentage of participants
|
25.2 percentage of participants
|
18.0 percentage of participants
|
7.8 percentage of participants
|
6.8 percentage of participants
|
6.0 percentage of participants
|
|
Phase 2 and 3: Percentage of Participants With Solicited Injection Site Reactions
Injection Site Swelling
|
11.3 percentage of participants
|
16.3 percentage of participants
|
2.0 percentage of participants
|
2.0 percentage of participants
|
4.2 percentage of participants
|
2.6 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to Day 56Population: Safety population included all participants who received at least one dose of the trial intervention.
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 reported. Injection site reactions were evaluated starting 30 minutes following the injection. Unsolicited injection site reactions were recorded for up to 28 days after administration of dose 2.
Outcome measures
| Measure |
Phase 2: INO-4800 Dose Group 1
n=151 Participants
Participants received one ID injection of 1.0 mg of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: INO-4800 Dose Group 2
n=147 Participants
Participants received 2 ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 1
n=50 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 2
n=51 Participants
Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)
n=601 Participants
Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: Placebo Dose Group
n=302 Participants
Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
|---|---|---|---|---|---|---|
|
Phase 2 and 3: Percentage of Participants With Unsolicited Injection Site Reactions
Injection Site Pain
|
27.2 percentage of participants
|
36.7 percentage of participants
|
22.0 percentage of participants
|
23.5 percentage of participants
|
19.3 percentage of participants
|
21.5 percentage of participants
|
|
Phase 2 and 3: Percentage of Participants With Unsolicited Injection Site Reactions
Injection Site Tenderness
|
0.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
1.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Phase 2 and 3: Percentage of Participants With Unsolicited Injection Site Reactions
Injection Site Erythema
|
17.9 percentage of participants
|
25.2 percentage of participants
|
18.0 percentage of participants
|
7.8 percentage of participants
|
6.8 percentage of participants
|
6.0 percentage of participants
|
|
Phase 2 and 3: Percentage of Participants With Unsolicited Injection Site Reactions
Injection Site Swelling
|
11.3 percentage of participants
|
16.3 percentage of participants
|
2.0 percentage of participants
|
2.0 percentage of participants
|
4.2 percentage of participants
|
2.6 percentage of participants
|
SECONDARY outcome
Timeframe: 7 days following each dose: Day 0 (Days 0 to Day 7) and Day 28 (Days 28 to Day 35)Population: Safety population included all participants who received at least one dose of the trial intervention.
An AE is defined as any untoward medical occurrence in a participant administered a trial intervention that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Participants were provided a diary to record the solicited systemic AEs. The solicited AEs were recorded for 7 days after each dose.
Outcome measures
| Measure |
Phase 2: INO-4800 Dose Group 1
n=151 Participants
Participants received one ID injection of 1.0 mg of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: INO-4800 Dose Group 2
n=147 Participants
Participants received 2 ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 1
n=50 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 2
n=51 Participants
Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)
n=601 Participants
Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: Placebo Dose Group
n=302 Participants
Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
|---|---|---|---|---|---|---|
|
Phase 2 and 3: Percentage of Participants With Solicited Adverse Events (AEs)
|
72.2 percentage of participants
|
83.7 percentage of participants
|
70.0 percentage of participants
|
56.9 percentage of participants
|
31.6 percentage of participants
|
31.5 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to Day 56Population: Safety population included all participants who received at least one dose of the trial intervention.
An AE is defined as any untoward medical occurrence in a participant administered a trial intervention that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AEs were recorded for up to 28 days after administration of dose 2.
Outcome measures
| Measure |
Phase 2: INO-4800 Dose Group 1
n=151 Participants
Participants received one ID injection of 1.0 mg of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: INO-4800 Dose Group 2
n=147 Participants
Participants received 2 ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 1
n=50 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 2
n=51 Participants
Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)
n=601 Participants
Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: Placebo Dose Group
n=302 Participants
Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
|---|---|---|---|---|---|---|
|
Phase 2 and 3: Percentage of Participants With Unsolicited AEs
|
74.2 percentage of participants
|
85.0 percentage of participants
|
74.0 percentage of participants
|
62.7 percentage of participants
|
38.8 percentage of participants
|
37.1 percentage of participants
|
SECONDARY outcome
Timeframe: Phase 2: From first dose of study drug up to Day 393; Phase 3: From first dose of study drug up to Day 126Population: Safety population included all participants who received at least one dose of the trial intervention.
An AE is defined as any untoward medical occurrence in a participant administered a trial intervention that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly or birth defect.
Outcome measures
| Measure |
Phase 2: INO-4800 Dose Group 1
n=151 Participants
Participants received one ID injection of 1.0 mg of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: INO-4800 Dose Group 2
n=147 Participants
Participants received 2 ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 1
n=50 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 2
n=51 Participants
Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)
n=601 Participants
Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: Placebo Dose Group
n=302 Participants
Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
|---|---|---|---|---|---|---|
|
Phase 2 and 3: Percentage of Participants With Serious Adverse Events (SAEs)
|
2.6 percentage of participants
|
1.4 percentage of participants
|
6.0 percentage of participants
|
3.9 percentage of participants
|
0.7 percentage of participants
|
1.3 percentage of participants
|
SECONDARY outcome
Timeframe: Phase 2: From first dose of study drug up to Day 393; Phase 3: From first dose of study drug up to Day 126Population: Safety population included all participants who received at least one dose of the trial intervention.
An AE is defined as any untoward medical occurrence in a participant administered a trial intervention that does not necessarily have a causal relationship with this treatment. An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate.
Outcome measures
| Measure |
Phase 2: INO-4800 Dose Group 1
n=151 Participants
Participants received one ID injection of 1.0 mg of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: INO-4800 Dose Group 2
n=147 Participants
Participants received 2 ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 1
n=50 Participants
Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 2
n=51 Participants
Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)
n=601 Participants
Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: Placebo Dose Group
n=302 Participants
Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
|---|---|---|---|---|---|---|
|
Phase 2 and 3: Percentage of Participants With Adverse Events of Special Interest (AESIs)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
2.0 percentage of participants
|
0.3 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 126Population: Safety population included all participants who received at least one dose of the trial intervention.
Outcome measures
| Measure |
Phase 2: INO-4800 Dose Group 1
n=601 Participants
Participants received one ID injection of 1.0 mg of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: INO-4800 Dose Group 2
n=302 Participants
Participants received 2 ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 1
Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 2
Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)
Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: Placebo Dose Group
Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
|---|---|---|---|---|---|---|
|
Phase 3: Number of Participants With Death From All Causes
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126)Population: For the Phase 3 segment, as pre-specified in the protocol, an independent EAC was to review and confirm the suspected COVID-19 cases which fulfilled the definition for virologically-confirmed COVID-19 cases. As the trial was prematurely terminated, suspected COVID-19 cases were not reconciled with the EAC. Therefore, data that was planned for the EAC to reconcile was not available for efficacy analysis and data could not be reported for the outcome measure.
The efficacy of INO-4800 in the prevention of COVID-19 disease was evaluated according to the degrees of COVID-19 disease severity in participants. Participants were confirmed cases of COVID-19, if tested positive by SARS-CoV-2 RT-PCR assay, with symptoms like fever (temperature of 100.4ºF/38.0ºC or higher), chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting, diarrhoea. The case definition of severe COVID-19 was participants with COVID-19 having clinical signs at rest indicative of severe systemic illness, respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to an intensive care unit, or death. The case definition for non-severe COVID-19 was participants with confirmed COVID-19, and which did not meet the case definition of severe COVID-19.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126)Population: For the Phase 3 segment, as pre-specified in the protocol, an independent EAC was to review and confirm the suspected COVID-19 cases which fulfilled the definition for virologically-confirmed COVID-19 cases. As the trial was prematurely terminated, suspected COVID-19 cases were not reconciled with the EAC. Therefore, data that was planned for the EAC to reconcile was not available for efficacy analysis and data could not be reported for the outcome measure.
The efficacy of INO-4800 in the prevention of COVID-19 disease was evaluated according to the degrees of COVID-19 disease severity in participants. Participants were confirmed cases of COVID-19, if tested positive by SARS-CoV-2 RT-PCR assay, with symptoms like fever (temperature of 100.4ºF/38.0ºC or higher), chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting, diarrhoea. The case definition of severe COVID-19 was participants with COVID-19 having clinical signs at rest indicative of severe systemic illness, respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to an intensive care unit, or death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126)Population: For the Phase 3 segment, as pre-specified in the protocol, an independent EAC was to review and confirm the suspected COVID-19 cases which fulfilled the definition for virologically-confirmed COVID-19 cases. As the trial was prematurely terminated, suspected COVID-19 cases were not reconciled with the EAC. Therefore, data that was planned for the EAC to reconcile was not available for efficacy analysis and data could not be reported for the outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126)Population: For the Phase 3 segment, as pre-specified in the protocol, an independent EAC was to review and confirm the suspected COVID-19 cases which fulfilled the definition for virologically-confirmed COVID-19 cases. As the trial was prematurely terminated, suspected COVID-19 cases were not reconciled with the EAC. Therefore, data that was planned for the EAC to reconcile was not available for efficacy analysis and data could not be reported for the outcome measure.
Participants were virologically-confirmed cases of COVID-19, if tested positive by SARS-CoV-2 RT-PCR assay, with symptoms like fever (temperature of 100.4ºF/38.0ºC or higher), chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting, diarrhoea. Participants with prior exposure to COVID-19 at baseline were considered for the analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Day 126Population: Due to the early termination of the study, immunogenicity analysis that was pre-specified in the protocol was not performed in the Phase 3 segment of the study. Hence, data for this outcome measure was not collected.
Whole blood and serum samples were collected for the cellular immunology assessment. The antigen-specific cellular immune response to INO-4800 were measured using ELISpot.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Day 126Population: Due to the early termination of the study, immunogenicity analysis that was pre-specified in the protocol was not performed in the Phase 3 segment of the study. Hence, data for this outcome measure was not collected.
The immune responses to INO-4800 were measured using assays that included a pseudovirus-based neutralization assay.
Outcome measures
Outcome data not reported
Adverse Events
Phase 2: INO-4800 Dose Group 1
Serious events: 4 serious events
Other events: 115 other events
Deaths: 0 deaths
Phase 2: INO-4800 Dose Group 2
Serious events: 2 serious events
Other events: 127 other events
Deaths: 0 deaths
Phase 2: Placebo Dose Group 1
Serious events: 3 serious events
Other events: 42 other events
Deaths: 1 deaths
Phase 2: Placebo Dose Group 2
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)
Serious events: 4 serious events
Other events: 279 other events
Deaths: 2 deaths
Phase 3: Placebo Dose Group
Serious events: 4 serious events
Other events: 140 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Phase 2: INO-4800 Dose Group 1
n=151 participants at risk
Participants received one ID injection of 1.0 mg of INO-4800 followed by electroporation (EP) using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: INO-4800 Dose Group 2
n=147 participants at risk
Participants received 2 ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 1
n=50 participants at risk
Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 2
n=51 participants at risk
Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)
n=601 participants at risk
Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: Placebo Dose Group
n=302 participants at risk
Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.17%
1/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.99%
3/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.33%
1/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
2.0%
1/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
2.0%
1/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.66%
1/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the cervix
|
0.00%
0/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
2.0%
1/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.66%
1/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
2.0%
1/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
2.0%
1/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Infections and infestations
Pyelonephritis
|
0.66%
1/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.17%
1/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.68%
1/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
2.0%
1/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.68%
1/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion incomplete
|
0.00%
0/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.17%
1/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.66%
1/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.17%
1/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.33%
1/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.17%
1/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.33%
1/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.66%
1/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
2.0%
1/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.66%
1/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.66%
1/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
2.0%
1/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
Other adverse events
| Measure |
Phase 2: INO-4800 Dose Group 1
n=151 participants at risk
Participants received one ID injection of 1.0 mg of INO-4800 followed by electroporation (EP) using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: INO-4800 Dose Group 2
n=147 participants at risk
Participants received 2 ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 1
n=50 participants at risk
Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 2: Placebo Dose Group 2
n=51 participants at risk
Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit)
n=601 participants at risk
Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
Phase 3: Placebo Dose Group
n=302 participants at risk
Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
|
|---|---|---|---|---|---|---|
|
General disorders
Injection site pruritus
|
37.1%
56/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
55.1%
81/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
26.0%
13/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
21.6%
11/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
10.0%
60/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
8.6%
26/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
General disorders
Injection site pain
|
27.8%
42/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
36.7%
54/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
22.0%
11/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
23.5%
12/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
19.5%
117/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
21.5%
65/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
General disorders
Fatigue
|
29.1%
44/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
38.8%
57/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
44.0%
22/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
21.6%
11/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
General disorders
Injection site erythema
|
18.5%
28/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
25.2%
37/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
18.0%
9/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
7.8%
4/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
7.2%
43/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
6.3%
19/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
General disorders
Injection site swelling
|
11.3%
17/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
16.3%
24/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
2.0%
1/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
2.0%
1/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
General disorders
Injection site bruising
|
2.6%
4/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
7.5%
11/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
3.9%
2/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
General disorders
Chills
|
4.0%
6/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
2.0%
3/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
6.0%
3/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
General disorders
Pyrexia
|
0.66%
1/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
4.1%
6/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
6.0%
3/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
5.5%
33/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
4.0%
12/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.5%
28/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
33.3%
49/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
26.0%
13/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
17.6%
9/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
6.5%
39/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
9.6%
29/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.6%
16/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
19.0%
28/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
10.0%
5/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
7.8%
4/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Nervous system disorders
Headache
|
27.8%
42/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
38.1%
56/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
42.0%
21/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
29.4%
15/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
10.1%
61/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
11.6%
35/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.3%
8/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
7.5%
11/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
8.0%
4/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
3.9%
2/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.6%
7/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
6.8%
10/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
6.0%
3/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
2.0%
1/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.6%
4/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
6.8%
10/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
10.0%
5/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.6%
4/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
2.0%
3/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
5.9%
3/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Gastrointestinal disorders
Nausea
|
9.3%
14/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
10.2%
15/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
10.0%
5/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
9.8%
5/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
General disorders
Malaise
|
0.00%
0/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
8.3%
50/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
8.9%
27/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
9.7%
58/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
10.3%
31/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
|
Infections and infestations
Influenza
|
0.00%
0/151 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/147 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/50 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
0.00%
0/51 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
6.2%
37/601 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
4.3%
13/302 • Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place