Trial Outcomes & Findings for GLS-5700 in Dengue Virus-Naïve Adults (NCT NCT02809443)
NCT ID: NCT02809443
Last Updated: 2024-12-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Day 0 through Week 60
Results posted on
2024-12-24
Participant Flow
Participant milestones
| Measure |
GLS-5700 at 1 mg
DNA/dose
GLS-5700: GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus
|
GLS-5700 at 2 mg
DNA/dose
GLS-5700: GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
17
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GLS-5700 in Dengue Virus-Naïve Adults
Baseline characteristics by cohort
| Measure |
GLS-5700 at 1 mg
n=20 Participants
DNA/dose
GLS-5700: GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus
|
GLS-5700 at 2 mg
n=20 Participants
DNA/dose
GLS-5700: GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
39.8 years
STANDARD_DEVIATION 13.19 • n=5 Participants
|
42.6 years
STANDARD_DEVIATION 14.25 • n=7 Participants
|
41.2 years
STANDARD_DEVIATION 13.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 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
|
0 Participants
n=7 Participants
|
0 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
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
31 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 through Week 60Outcome measures
| Measure |
GLS-5700 at 1 mg
n=20 Participants
DNA/dose
GLS-5700: GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus
|
GLS-5700 at 2 mg
n=20 Participants
DNA/dose
GLS-5700: GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus
|
|---|---|---|
|
Number of Participants With Serious Adverse Events From Day 0 Through Week 60
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 14 (2 weeks after the 3rd dose)Population: Participants who had received all 3 doses of GLS-5700 in a 1-mg or 2-mg dose.
Serum samples were analyzed on enzyme-linked immunosorbent assay (ELISA) to measure binding-antibody responses to recombinant vaccine-matched ZIKV envelope (rZIKV-E) protein and reported as the number of participants who responded.
Outcome measures
| Measure |
GLS-5700 at 1 mg
n=20 Participants
DNA/dose
GLS-5700: GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus
|
GLS-5700 at 2 mg
n=19 Participants
DNA/dose
GLS-5700: GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus
|
|---|---|---|
|
Binding Antibody Response to Zika Envelope
|
20 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Maximum response over follow up period up to 60 weeks.PBMCs were tested in enzyme-linked immunospot (ELISPOT) assay to detect the production of interferon-γ-secreting cells in response to stimulation with ZIKV premembrane and envelope peptides
Outcome measures
| Measure |
GLS-5700 at 1 mg
n=18 Participants
DNA/dose
GLS-5700: GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus
|
GLS-5700 at 2 mg
n=19 Participants
DNA/dose
GLS-5700: GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus
|
|---|---|---|
|
T Cell Response
|
35 Spot Forming Units per million cells
Interval 15.0 to 72.0
|
154 Spot Forming Units per million cells
Interval 42.0 to 283.0
|
Adverse Events
GLS-5700 at 1 mg
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
GLS-5700 at 2 mg
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GLS-5700 at 1 mg
n=20 participants at risk
DNA/dose
GLS-5700: GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus
|
GLS-5700 at 2 mg
n=20 participants at risk
DNA/dose
GLS-5700: GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus
|
|---|---|---|
|
Surgical and medical procedures
Pain at injection site
|
100.0%
20/20 • Number of events 20 • Adverse Event data were collected from Week 0 through Week 60.
Adverse events were graded according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials guidelines that were issued by the Food and Drug Administration in September 2007.
|
100.0%
20/20 • Number of events 20 • Adverse Event data were collected from Week 0 through Week 60.
Adverse events were graded according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials guidelines that were issued by the Food and Drug Administration in September 2007.
|
Additional Information
Senior Clinical Operations Associate
GeneOne Life Science
Phone: 6106576351
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place