Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 59 of 126 for:    HSV-2

Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03146403
Recruitment Status : Terminated (2017 business decision to cease GEN-003 spending.)
First Posted : May 9, 2017
Results First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Genocea Biosciences, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Genital Herpes
HSV-2 Infection
Interventions Biological: GEN-003
Biological: Matrix-M2
Other: 0.9% normal saline
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GEN-003 Placebo
Hide Arm/Group Description

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.

0.9% normal saline administered as a 0.5mL intramuscular (IM) injection

0.9% normal saline: Placebo

Period Title: Overall Study
Started 16 17
Completed 14 14
Not Completed 2 3
Reason Not Completed
Withdrawal by Subject             0             3
Lost to Follow-up             2             0
Arm/Group Title GEN-003 Placebo Total
Hide Arm/Group Description

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.

0.9% normal saline administered as a 0.5mL intramuscular (IM) injection

0.9% normal saline: Placebo

Total of all reporting groups
Overall Number of Baseline Participants 16 17 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants 17 participants 33 participants
39.9
(27 to 50)
40.2
(30 to 52)
40.1
(27 to 52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 33 participants
Female
11
  68.8%
12
  70.6%
23
  69.7%
Male
5
  31.3%
5
  29.4%
10
  30.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 33 participants
Hispanic or Latino
2
  12.5%
1
   5.9%
3
   9.1%
Not Hispanic or Latino
14
  87.5%
16
  94.1%
30
  90.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 33 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   5.9%
1
   3.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  31.3%
7
  41.2%
12
  36.4%
White
11
  68.8%
8
  47.1%
19
  57.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   5.9%
1
   3.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 17 participants 33 participants
16 17 33
Weight  
Mean (Full Range)
Unit of measure:  Kilograms
Number Analyzed 16 participants 17 participants 33 participants
82.34
(54.0 to 140.5)
79.20
(53.5 to 119.3)
80.72
(53.5 to 140.5)
1.Primary Outcome
Title Percentage of Days With Genital Herpes Lesions
Hide Description Subject-reported via electronic diary
Time Frame The 6-month period after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Results for the placebo group are based on 16 subjects, after excluding one subject who reported no electronic diary lesion data.
Arm/Group Title GEN-003 Placebo
Hide Arm/Group Description:

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.

0.9% normal saline administered as a 0.5mL intramuscular (IM) injection

0.9% normal saline: Placebo

Overall Number of Participants Analyzed 16 16
Median (Full Range)
Unit of Measure: percentage of days
2.58
(0.0 to 21.8)
4.23
(0.0 to 13.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GEN-003, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7474
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Number of Genital Herpes Recurrences
Hide Description Subject-reported via electronic diary
Time Frame The 6-month period after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Results for the placebo group are based on 16 subjects, after excluding one subject who reported no electronic diary lesion data.
Arm/Group Title GEN-003 Placebo
Hide Arm/Group Description:

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.

0.9% normal saline administered as a 0.5mL intramuscular (IM) injection

0.9% normal saline: Placebo

Overall Number of Participants Analyzed 16 16
Median (Full Range)
Unit of Measure: recurrences
1.50
(0.0 to 6.0)
1.50
(0.0 to 9.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GEN-003, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6450
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Number of Subjects Without Genital Herpes Recurrence
Hide Description Subject-reported via electronic diary
Time Frame 6 months after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Results for the placebo group are based on 16 subjects, after excluding one subject who reported no electronic diary lesion data.
Arm/Group Title GEN-003 Placebo
Hide Arm/Group Description:

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.

0.9% normal saline administered as a 0.5mL intramuscular (IM) injection

0.9% normal saline: Placebo

Overall Number of Participants Analyzed 16 16
Measure Type: Count of Participants
Unit of Measure: Participants
No Recurrence
1
   6.3%
3
  18.8%
With Recurrence
13
  81.3%
12
  75.0%
Unknown
2
  12.5%
1
   6.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GEN-003, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3157
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Days Until First Genital Herpes Recurrence
Hide Description Subject-reported via electronic diary
Time Frame The 6-month period after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Results for the placebo group are based on 16 subjects, after excluding one subject who reported no electronic diary lesion data.
Arm/Group Title GEN-003 Placebo
Hide Arm/Group Description:

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.

0.9% normal saline administered as a 0.5mL intramuscular (IM) injection

0.9% normal saline: Placebo

Overall Number of Participants Analyzed 16 16
Median (95% Confidence Interval)
Unit of Measure: days
25
(6.0 to 85.0)
51
(17.0 to 116.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GEN-003, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3869
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
5.Secondary Outcome
Title Duration of Genital Herpes Recurrences
Hide Description Time in days per genital herpes recurrence
Time Frame The 6-month period after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GEN-003 Placebo
Hide Arm/Group Description:

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.

0.9% normal saline administered as a 0.5mL intramuscular (IM) injection

0.9% normal saline: Placebo

Overall Number of Participants Analyzed 13 12
Median (Full Range)
Unit of Measure: days
2.83
(1 to 7)
3.40
(1 to 6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GEN-003, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2200
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 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.
Adverse Event Reporting Description 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.
 
Arm/Group Title GEN-003 Placebo
Hide Arm/Group Description

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.

0.9% normal saline administered as a 0.5mL intramuscular (IM) injection

0.9% normal saline: Placebo

All-Cause Mortality
GEN-003 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/17 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
GEN-003 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GEN-003 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   16/16 (100.00%)   10/17 (58.82%) 
Gastrointestinal disorders     
Nausea   6/16 (37.50%)  1/16 (6.25%) 
Diarrhea   3/16 (18.75%)  1/16 (6.25%) 
General disorders     
Fatigue *  2/16 (12.50%)  0/17 (0.00%) 
Disturbance in attention *  1/16 (6.25%)  0/17 (0.00%) 
Injection Site Pain   15/16 (93.75%)  3/16 (18.75%) 
Injection Site Tenderness   15/16 (93.75%)  7/16 (43.75%) 
Injection Site Swelling   13/16 (81.25%)  3/16 (18.75%) 
Injection Site Redness   5/16 (31.25%)  2/16 (12.50%) 
Fever  [1]  3/16 (18.75%)  0/16 (0.00%) 
Chills   10/16 (62.50%)  1/16 (6.25%) 
Fatigue   14/16 (87.50%)  5/16 (31.25%) 
Infections and infestations     
Sinusitis *  1/16 (6.25%)  0/17 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscle Aches   15/16 (93.75%)  2/16 (12.50%) 
Nervous system disorders     
Headache *  1/16 (6.25%)  0/17 (0.00%) 
Headache   13/16 (81.25%)  7/16 (43.75%) 
Skin and subcutaneous tissue disorders     
Flushing *  1/16 (6.25%)  0/17 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
≥100.4°F
Small numbers of enrolled subjects likely led to a lack of statistical power. After a 2017 business decision to cease GEN-003 spending, the outcome measures were reduced to 6 months of follow up, rather than the originally planned 12 months.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jennifer LaVin
Organization: Genocea
Phone: 617-876-8191
EMail: jennifer.lavin@genocea.com
Layout table for additonal information
Responsible Party: Genocea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT03146403     History of Changes
Other Study ID Numbers: GEN-003-005
First Submitted: May 5, 2017
First Posted: May 9, 2017
Results First Submitted: December 21, 2018
Results First Posted: February 19, 2019
Last Update Posted: February 19, 2019