Trial Outcomes & Findings for Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine (NCT NCT00290147)
NCT ID: NCT00290147
Last Updated: 2017-06-20
Results Overview
Summary of ungraded systemic and local reactogenicity symptoms following each vaccination
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
Months 0, 1 and 5
Results posted on
2017-06-20
Participant Flow
22 healthy adult volunteers enrolled to participate at the Naval Medical Research Center site
Participant milestones
| Measure |
1.0 mg of D1ME100 Vaccine
1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector
|
5.0 mg of D1ME100 Vaccine
5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
|
Overall Study
COMPLETED
|
10
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine
Baseline characteristics by cohort
| Measure |
1.0 mg of D1ME100 Vaccine
n=10 Participants
1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector
|
5.0 mg of D1ME100 Vaccine
n=12 Participants
5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.4 years
STANDARD_DEVIATION 8.60 • n=5 Participants
|
36.9 years
STANDARD_DEVIATION 9.89 • n=7 Participants
|
38.5 years
STANDARD_DEVIATION 9.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 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
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Active Duty Military
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Civilian
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Months 0, 1 and 5Summary of ungraded systemic and local reactogenicity symptoms following each vaccination
Outcome measures
| Measure |
1.0 mg of D1ME100 Vaccine
n=10 Participants
1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector
|
5.0 mg of D1ME100 Vaccine
n=12 Participants
5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector
|
|---|---|---|
|
Systemic and Local Reactogenicity Rates for Ungraded Symptoms
Systemic: Fever
|
0 Participants
|
1 Participants
|
|
Systemic and Local Reactogenicity Rates for Ungraded Symptoms
Systemic: Chills
|
0 Participants
|
2 Participants
|
|
Systemic and Local Reactogenicity Rates for Ungraded Symptoms
Systemic: Rash
|
0 Participants
|
0 Participants
|
|
Systemic and Local Reactogenicity Rates for Ungraded Symptoms
Systemic: Loss of Appetite
|
0 Participants
|
2 Participants
|
|
Systemic and Local Reactogenicity Rates for Ungraded Symptoms
Systemic: Red Eyes
|
1 Participants
|
0 Participants
|
|
Systemic and Local Reactogenicity Rates for Ungraded Symptoms
Local: Redness at Vaccine Site
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 monthsNumber of participants who responded, are reported. Response or a positive ELISPOT assay was defined as \>65 spot forming cells per million PBMC for T-cells and \>20 spot forming cells per million PBMC for B-cells
Outcome measures
| Measure |
1.0 mg of D1ME100 Vaccine
n=9 Participants
1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector
|
5.0 mg of D1ME100 Vaccine
n=12 Participants
5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector
|
|---|---|---|
|
Anti-dengue Antibody and T-cell and B-cell Responders
B-Cell : All
|
4 Participants
|
7 Participants
|
|
Anti-dengue Antibody and T-cell and B-cell Responders
B-Cell : DEN-1
|
4 Participants
|
6 Participants
|
|
Anti-dengue Antibody and T-cell and B-cell Responders
B-Cell : DEN-2
|
4 Participants
|
2 Participants
|
|
Anti-dengue Antibody and T-cell and B-cell Responders
B-Cell : DEN-3
|
4 Participants
|
7 Participants
|
|
Anti-dengue Antibody and T-cell and B-cell Responders
B-Cell : DEN-4
|
3 Participants
|
8 Participants
|
|
Anti-dengue Antibody and T-cell and B-cell Responders
T-Cell : All
|
5 Participants
|
11 Participants
|
|
Anti-dengue Antibody and T-cell and B-cell Responders
T-Cell : DEN-1
|
5 Participants
|
11 Participants
|
|
Anti-dengue Antibody and T-cell and B-cell Responders
T-Cell : DEN-2
|
2 Participants
|
6 Participants
|
|
Anti-dengue Antibody and T-cell and B-cell Responders
T-Cell : DEN-3
|
2 Participants
|
6 Participants
|
|
Anti-dengue Antibody and T-cell and B-cell Responders
T-Cell : DEN-4
|
1 Participants
|
7 Participants
|
Adverse Events
1.0 mg of D1ME100 Vaccine
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
5.0 mg of D1ME100 Vaccine
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1.0 mg of D1ME100 Vaccine
n=10 participants at risk
1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector
|
5.0 mg of D1ME100 Vaccine
n=12 participants at risk
5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector
|
|---|---|---|
|
Psychiatric disorders
Alcohol withdrawal
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
1.0 mg of D1ME100 Vaccine
n=10 participants at risk
1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector
|
5.0 mg of D1ME100 Vaccine
n=12 participants at risk
5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months
D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector
|
|---|---|---|
|
General disorders
Malaise
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
General disorders
Tenderness
|
20.0%
2/10 • Number of events 2 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Echymosis right arm following trauma
|
10.0%
1/10 • Number of events 1 • 12 months
|
0.00%
0/12 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Right arm pain following trauma
|
20.0%
2/10 • Number of events 2 • 12 months
|
0.00%
0/12 • 12 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10 • 12 months
|
33.3%
4/12 • Number of events 4 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Seasonal allergic rhinitis
|
10.0%
1/10 • Number of events 1 • 12 months
|
0.00%
0/12 • 12 months
|
|
General disorders
Chest pain following trauma
|
10.0%
1/10 • Number of events 1 • 12 months
|
0.00%
0/12 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Jaw pain following trauma
|
10.0%
1/10 • Number of events 1 • 12 months
|
0.00%
0/12 • 12 months
|
|
Investigations
Elevated CPK
|
10.0%
1/10 • Number of events 1 • 12 months
|
0.00%
0/12 • 12 months
|
|
Investigations
Low blood sugar
|
10.0%
1/10 • Number of events 1 • 12 months
|
0.00%
0/12 • 12 months
|
|
Investigations
Decreased bicarbonate level
|
20.0%
2/10 • Number of events 2 • 12 months
|
0.00%
0/12 • 12 months
|
|
Investigations
Increased diastolic BP
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Burn left hand following trauma
|
10.0%
1/10 • Number of events 1 • 12 months
|
0.00%
0/12 • 12 months
|
|
Investigations
Increased systolic BP
|
10.0%
1/10 • Number of events 1 • 12 months
|
25.0%
3/12 • Number of events 3 • 12 months
|
|
Investigations
Urine - Trace protein
|
10.0%
1/10 • Number of events 1 • 12 months
|
0.00%
0/12 • 12 months
|
|
Investigations
Elevated eosinophilis
|
10.0%
1/10 • Number of events 1 • 12 months
|
0.00%
0/12 • 12 months
|
|
Investigations
Decreased HgB
|
10.0%
1/10 • Number of events 1 • 12 months
|
0.00%
0/12 • 12 months
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Eye disorders
Conjunctivitis
|
10.0%
1/10 • Number of events 1 • 12 months
|
0.00%
0/12 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Right shoulder discomfort
|
10.0%
1/10 • Number of events 1 • 12 months
|
0.00%
0/12 • 12 months
|
|
Investigations
Elevated CK
|
10.0%
1/10 • Number of events 1 • 12 months
|
0.00%
0/12 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • 12 months
|
41.7%
5/12 • Number of events 5 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
General disorders
Flu illness
|
10.0%
1/10 • Number of events 1 • 12 months
|
0.00%
0/12 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Number of events 1 • 12 months
|
0.00%
0/12 • 12 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Right lower wisdom tooth pain / impaction
|
10.0%
1/10 • Number of events 1 • 12 months
|
0.00%
0/12 • 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Number of events 1 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Intermittent left arm pain
|
10.0%
1/10 • Number of events 1 • 12 months
|
0.00%
0/12 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Intermittent left arm weakness
|
10.0%
1/10 • Number of events 1 • 12 months
|
0.00%
0/12 • 12 months
|
|
Nervous system disorders
Black out (syncope) episode
|
10.0%
1/10 • Number of events 1 • 12 months
|
0.00%
0/12 • 12 months
|
|
Infections and infestations
Herpes zoster (shingles)
|
10.0%
1/10 • Number of events 1 • 12 months
|
0.00%
0/12 • 12 months
|
|
Investigations
Elevated calcium
|
10.0%
1/10 • Number of events 1 • 12 months
|
0.00%
0/12 • 12 months
|
|
General disorders
Induration
|
10.0%
1/10 • Number of events 1 • 12 months
|
66.7%
8/12 • Number of events 8 • 12 months
|
|
Investigations
Elevated systolic BP
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • 12 months
|
25.0%
3/12 • Number of events 3 • 12 months
|
|
Eye disorders
Photophobia
|
0.00%
0/10 • 12 months
|
16.7%
2/12 • Number of events 2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Right shoulder pain
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
General disorders
Flu-like syndrome (fever, chills)
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/10 • 12 months
|
100.0%
12/12 • Number of events 12 • 12 months
|
|
Investigations
Increased respiratory rate
|
0.00%
0/10 • 12 months
|
25.0%
3/12 • Number of events 3 • 12 months
|
|
Nervous system disorders
Loss of taste
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
General disorders
Papule (skin lesion) at vaccination site
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Infections and infestations
Cold
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Burn on left ankle
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Trace proteinuria
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Infections and infestations
Tooth infection
|
0.00%
0/10 • 12 months
|
16.7%
2/12 • Number of events 2 • 12 months
|
|
Eye disorders
Eye pain
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/10 • 12 months
|
16.7%
2/12 • Number of events 2 • 12 months
|
|
Psychiatric disorders
Weird dreams (nightmares)
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/10 • 12 months
|
16.7%
2/12 • Number of events 2 • 12 months
|
|
Injury, poisoning and procedural complications
Left forearm injury and pain
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Investigations
Decreased WBC - 3.3
|
0.00%
0/10 • 12 months
|
16.7%
2/12 • Number of events 2 • 12 months
|
|
Investigations
Elevated systolic BP (142)
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Investigations
Decreased lymphocytes (818)
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Investigations
Low WBC
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Investigations
Low lymphocyte count
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Right knee pain (increased)
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Investigations
Elevated creatinine
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Investigations
Low hemoglobin
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Mild anemia
|
0.00%
0/10 • 12 months
|
16.7%
2/12 • Number of events 2 • 12 months
|
|
Investigations
Decreased absolute lymphocytes
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Investigations
Elevated creatine kinase
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Indegestion
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Investigations
Elevated DBP (93)
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Investigations
Elevated diastolic blood pressure
|
0.00%
0/10 • 12 months
|
16.7%
2/12 • Number of events 2 • 12 months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Investigations
Elevated AST
|
0.00%
0/10 • 12 months
|
25.0%
3/12 • Number of events 3 • 12 months
|
|
Investigations
Low bicarbonate
|
0.00%
0/10 • 12 months
|
16.7%
2/12 • Number of events 2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Investigations
Elevated diastolic BP
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Investigations
Decreased CO2
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Right thigh pain (s/p fall)
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
General disorders
Chills
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Investigations
Trace protein on uA
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Investigations
Elevated BUN
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Investigations
Increased CPK
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Investigations
Increased HR (109)
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Tooth pain
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Investigations
Decreased hemoglobin
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Investigations
Increased respiratory rate - 22
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back ache
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
|
Investigations
Decreased blood glucose
|
0.00%
0/10 • 12 months
|
8.3%
1/12 • Number of events 1 • 12 months
|
Additional Information
Charmagne Beckett, LCDR, MC, USNR
Naval Medical Research Center, Viral Diseases Department
Phone: 301-295-6400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place