Trial Outcomes & Findings for Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection (NCT NCT03146403)
NCT ID: NCT03146403
Last Updated: 2019-02-19
Results Overview
Subject-reported via electronic diary
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
The 6-month period after vaccination
Results posted on
2019-02-19
Participant Flow
Participant milestones
| Measure |
GEN-003
60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection
GEN-003: HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D
Matrix-M2: Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
|
Placebo
0.9% normal saline administered as a 0.5mL intramuscular (IM) injection
0.9% normal saline: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
GEN-003
60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection
GEN-003: HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D
Matrix-M2: Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
|
Placebo
0.9% normal saline administered as a 0.5mL intramuscular (IM) injection
0.9% normal saline: Placebo
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection
Baseline characteristics by cohort
| Measure |
GEN-003
n=16 Participants
60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection
GEN-003: HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D
Matrix-M2: Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
|
Placebo
n=17 Participants
0.9% normal saline administered as a 0.5mL intramuscular (IM) injection
0.9% normal saline: Placebo
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.9 years
n=5 Participants
|
40.2 years
n=7 Participants
|
40.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
17 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Weight
|
82.34 kilograms
n=5 Participants
|
79.20 kilograms
n=7 Participants
|
80.72 kilograms
n=5 Participants
|
PRIMARY outcome
Timeframe: The 6-month period after vaccinationPopulation: Results for the placebo group are based on 16 subjects, after excluding one subject who reported no electronic diary lesion data.
Subject-reported via electronic diary
Outcome measures
| Measure |
GEN-003
n=16 Participants
60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection
GEN-003: HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D
Matrix-M2: Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
|
Placebo
n=16 Participants
0.9% normal saline administered as a 0.5mL intramuscular (IM) injection
0.9% normal saline: Placebo
|
|---|---|---|
|
Percentage of Days With Genital Herpes Lesions
|
2.58 percentage of days
Interval 0.0 to 21.8
|
4.23 percentage of days
Interval 0.0 to 13.5
|
SECONDARY outcome
Timeframe: The 6-month period after vaccinationPopulation: Results for the placebo group are based on 16 subjects, after excluding one subject who reported no electronic diary lesion data.
Subject-reported via electronic diary
Outcome measures
| Measure |
GEN-003
n=16 Participants
60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection
GEN-003: HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D
Matrix-M2: Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
|
Placebo
n=16 Participants
0.9% normal saline administered as a 0.5mL intramuscular (IM) injection
0.9% normal saline: Placebo
|
|---|---|---|
|
Number of Genital Herpes Recurrences
|
1.50 recurrences
Interval 0.0 to 6.0
|
1.50 recurrences
Interval 0.0 to 9.0
|
SECONDARY outcome
Timeframe: 6 months after vaccinationPopulation: Results for the placebo group are based on 16 subjects, after excluding one subject who reported no electronic diary lesion data.
Subject-reported via electronic diary
Outcome measures
| Measure |
GEN-003
n=16 Participants
60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection
GEN-003: HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D
Matrix-M2: Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
|
Placebo
n=16 Participants
0.9% normal saline administered as a 0.5mL intramuscular (IM) injection
0.9% normal saline: Placebo
|
|---|---|---|
|
Number of Subjects Without Genital Herpes Recurrence
No Recurrence
|
1 Participants
|
3 Participants
|
|
Number of Subjects Without Genital Herpes Recurrence
With Recurrence
|
13 Participants
|
12 Participants
|
|
Number of Subjects Without Genital Herpes Recurrence
Unknown
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: The 6-month period after vaccinationPopulation: Results for the placebo group are based on 16 subjects, after excluding one subject who reported no electronic diary lesion data.
Subject-reported via electronic diary
Outcome measures
| Measure |
GEN-003
n=16 Participants
60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection
GEN-003: HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D
Matrix-M2: Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
|
Placebo
n=16 Participants
0.9% normal saline administered as a 0.5mL intramuscular (IM) injection
0.9% normal saline: Placebo
|
|---|---|---|
|
Days Until First Genital Herpes Recurrence
|
25 days
Interval 6.0 to 85.0
|
51 days
Interval 17.0 to 116.0
|
SECONDARY outcome
Timeframe: The 6-month period after vaccinationTime in days per genital herpes recurrence
Outcome measures
| Measure |
GEN-003
n=13 Participants
60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection
GEN-003: HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D
Matrix-M2: Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
|
Placebo
n=12 Participants
0.9% normal saline administered as a 0.5mL intramuscular (IM) injection
0.9% normal saline: Placebo
|
|---|---|---|
|
Duration of Genital Herpes Recurrences
|
2.83 days
Interval 1.0 to 7.0
|
3.40 days
Interval 1.0 to 6.0
|
Adverse Events
GEN-003
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GEN-003
n=16 participants at risk
60μg of each GEN-003 antigen with 50μg Matrix-M2 adjuvant, administered as a 0.5mL intramuscular (IM) injection
GEN-003: HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D
Matrix-M2: Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
|
Placebo
n=17 participants at risk
0.9% normal saline administered as a 0.5mL intramuscular (IM) injection
0.9% normal saline: Placebo
|
|---|---|---|
|
General disorders
Fatigue
|
87.5%
14/16 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
31.2%
5/16 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
|
Infections and infestations
Sinusitis
|
6.2%
1/16 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
0.00%
0/17 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
|
Nervous system disorders
Headache
|
81.2%
13/16 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
43.8%
7/16 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
|
General disorders
Disturbance in attention
|
6.2%
1/16 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
0.00%
0/17 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
6.2%
1/16 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
0.00%
0/17 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
|
General disorders
Injection Site Pain
|
93.8%
15/16 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
18.8%
3/16 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
|
General disorders
Injection Site Tenderness
|
93.8%
15/16 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
43.8%
7/16 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
|
General disorders
Injection Site Swelling
|
81.2%
13/16 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
18.8%
3/16 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
|
General disorders
Injection Site Redness
|
31.2%
5/16 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
12.5%
2/16 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
|
General disorders
Fever
|
18.8%
3/16 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
0.00%
0/16 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
|
General disorders
Chills
|
62.5%
10/16 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
6.2%
1/16 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
|
Gastrointestinal disorders
Nausea
|
37.5%
6/16 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
6.2%
1/16 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
|
Gastrointestinal disorders
Diarrhea
|
18.8%
3/16 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
6.2%
1/16 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
|
Musculoskeletal and connective tissue disorders
Muscle Aches
|
93.8%
15/16 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
12.5%
2/16 • Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.
Systematic AE results for the placebo group are based on 16 subjects since one subject who withdrew from the study did not report local reactions and systemic events data.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place