Dengue
Conditions
Keywords
Dengue, DNA vaccine
Brief summary
The purpose of this study is to exame the safety of a DNA vaccine against dengue-1.
Detailed description
Dengue is a desease that affects 100 million people throughout the world mainly in tropical countries in the South Pacific, Asia, the Caribbean, and Africa. The disease often presents with high fever, severe headache, and joint/muscle pain that usually goes away on its own, but it can also present as a sometimes deadly hemorrhagic (bleeding) disease. Humans catch this disease by being bitten by mosquitoes that have been infected with dengue virus. Scientists at the Naval Medical Research Center have been working on vaccines to prevent dengue disease. This vaccine, referred to as D1ME, is an experimental DNA vaccine that contains genes from the dengue-1 virus. The purpose of this study is to test the safety of a new experimental vaccine against dengue and to see if the vaccine can stimulate the immune system.
Interventions
BIOLOGICALD1ME100 (dengue-1 premembrane/envelope DNA vaccine)
IM injection delivered by Biojector
Sponsors
United States Army Medical Materiel Development Activity
U.S. Army Medical Research and Development Command
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Available to participate for the duration of the study (approximately 12 months) * Completion and review of knowledge assement quiz
Exclusion criteria
* Pregnant (by history or as ascertained by pregnancy test) or lactating female * Female who intends to become pregnant during the study * Plan to have elective surgery during the study period * HIV infection * Known immunodeficiency or currently receiving immunosuppressive therapy (inhaled and topical steroids are allowed) * History of splenectomy * Administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine and ending 30 days after vaccination * Evidence of active (acute or chronic) hepatitis B or C infection * Autoimmune diseaseor subjects who describe a first-degree relative with clearly documented autoimmune disease * Acute or chronic, clinically significant cardiac, pulmonary, hepatic, or renal abnormality, as determined by physical examination or basic laboratory screening * Clinical or laboratory evidence of significant anemia * History of flavivirus infection or previous receipt of flavivirus vaccine * Positive serology for flaviviruses (all four dengue virus serotypes, Japanese encephalitis, Yellow fever virus, and West Nile virus), HIV-1, Hepatitis B surface antigen, or anti-hepatitis C virus antibodies prior to enrollment * Use of any investigational or non-registered drug or vaccine other than the study vaccine within 60 days preceding the first dose of study vaccine, or planned use during the study period. * Previous history of allergic or anaphylactic reaction to any vaccine * Planned travel to areas with endemic dengue during the study period * Any other significant finding which, in the opinion of the investigator, would increase the risk of having an adverse outcome from participating in this protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systemic and Local Reactogenicity Rates for Ungraded Symptoms | Months 0, 1 and 5 | Summary of ungraded systemic and local reactogenicity symptoms following each vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-dengue Antibody and T-cell and B-cell Responders | 12 months | Number 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 |
Countries
United States
Participant flow
Recruitment details
22 healthy adult volunteers enrolled to participate at the Naval Medical Research Center site
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| 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 | 12 |
| Total | 22 |
Baseline characteristics
| Characteristic | 1.0 mg of D1ME100 Vaccine | Total | 5.0 mg of D1ME100 Vaccine |
|---|---|---|---|
| Active Duty Military | 0 Participants | 2 Participants | 2 Participants |
| Age, Continuous | 40.4 years STANDARD_DEVIATION 8.6 | 38.5 years STANDARD_DEVIATION 9.28 | 36.9 years STANDARD_DEVIATION 9.89 |
| Civilian | 10 Participants | 20 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 15 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 1 Participants | 3 Participants | 2 Participants |
| Region of Enrollment United States | 10 participants | 22 participants | 12 participants |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 3 Participants |
| Sex: Female, Male Male | 6 Participants | 15 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 12 |
| other Total, other adverse events | 10 / 10 | 12 / 12 |
| serious Total, serious adverse events | 0 / 10 | 1 / 12 |
Outcome results
Primary
Systemic and Local Reactogenicity Rates for Ungraded Symptoms
Summary of ungraded systemic and local reactogenicity symptoms following each vaccination
Time frame: Months 0, 1 and 5
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 1.0 mg of D1ME100 Vaccine | Systemic and Local Reactogenicity Rates for Ungraded Symptoms | Systemic: Fever | 0 Participants |
| 1.0 mg of D1ME100 Vaccine | Systemic and Local Reactogenicity Rates for Ungraded Symptoms | Systemic: Chills | 0 Participants |
| 1.0 mg of D1ME100 Vaccine | Systemic and Local Reactogenicity Rates for Ungraded Symptoms | Systemic: Rash | 0 Participants |
| 1.0 mg of D1ME100 Vaccine | Systemic and Local Reactogenicity Rates for Ungraded Symptoms | Systemic: Loss of Appetite | 0 Participants |
| 1.0 mg of D1ME100 Vaccine | Systemic and Local Reactogenicity Rates for Ungraded Symptoms | Systemic: Red Eyes | 1 Participants |
| 1.0 mg of D1ME100 Vaccine | Systemic and Local Reactogenicity Rates for Ungraded Symptoms | Local: Redness at Vaccine Site | 0 Participants |
| 5.0 mg of D1ME100 Vaccine | Systemic and Local Reactogenicity Rates for Ungraded Symptoms | Systemic: Red Eyes | 0 Participants |
| 5.0 mg of D1ME100 Vaccine | Systemic and Local Reactogenicity Rates for Ungraded Symptoms | Systemic: Fever | 1 Participants |
| 5.0 mg of D1ME100 Vaccine | Systemic and Local Reactogenicity Rates for Ungraded Symptoms | Systemic: Loss of Appetite | 2 Participants |
| 5.0 mg of D1ME100 Vaccine | Systemic and Local Reactogenicity Rates for Ungraded Symptoms | Systemic: Chills | 2 Participants |
| 5.0 mg of D1ME100 Vaccine | Systemic and Local Reactogenicity Rates for Ungraded Symptoms | Local: Redness at Vaccine Site | 5 Participants |
| 5.0 mg of D1ME100 Vaccine | Systemic and Local Reactogenicity Rates for Ungraded Symptoms | Systemic: Rash | 0 Participants |
Secondary
Anti-dengue Antibody and T-cell and B-cell Responders
Number 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
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 1.0 mg of D1ME100 Vaccine | Anti-dengue Antibody and T-cell and B-cell Responders | B-Cell : DEN-2 | 4 Participants |
| 1.0 mg of D1ME100 Vaccine | Anti-dengue Antibody and T-cell and B-cell Responders | T-Cell : All | 5 Participants |
| 1.0 mg of D1ME100 Vaccine | Anti-dengue Antibody and T-cell and B-cell Responders | B-Cell : DEN-1 | 4 Participants |
| 1.0 mg of D1ME100 Vaccine | Anti-dengue Antibody and T-cell and B-cell Responders | T-Cell : DEN-1 | 5 Participants |
| 1.0 mg of D1ME100 Vaccine | Anti-dengue Antibody and T-cell and B-cell Responders | B-Cell : DEN-3 | 4 Participants |
| 1.0 mg of D1ME100 Vaccine | Anti-dengue Antibody and T-cell and B-cell Responders | T-Cell : DEN-2 | 2 Participants |
| 1.0 mg of D1ME100 Vaccine | Anti-dengue Antibody and T-cell and B-cell Responders | B-Cell : All | 4 Participants |
| 1.0 mg of D1ME100 Vaccine | Anti-dengue Antibody and T-cell and B-cell Responders | B-Cell : DEN-4 | 3 Participants |
| 1.0 mg of D1ME100 Vaccine | Anti-dengue Antibody and T-cell and B-cell Responders | T-Cell : DEN-4 | 1 Participants |
| 1.0 mg of D1ME100 Vaccine | Anti-dengue Antibody and T-cell and B-cell Responders | T-Cell : DEN-3 | 2 Participants |
| 5.0 mg of D1ME100 Vaccine | Anti-dengue Antibody and T-cell and B-cell Responders | T-Cell : DEN-4 | 7 Participants |
| 5.0 mg of D1ME100 Vaccine | Anti-dengue Antibody and T-cell and B-cell Responders | B-Cell : All | 7 Participants |
| 5.0 mg of D1ME100 Vaccine | Anti-dengue Antibody and T-cell and B-cell Responders | B-Cell : DEN-1 | 6 Participants |
| 5.0 mg of D1ME100 Vaccine | Anti-dengue Antibody and T-cell and B-cell Responders | B-Cell : DEN-2 | 2 Participants |
| 5.0 mg of D1ME100 Vaccine | Anti-dengue Antibody and T-cell and B-cell Responders | B-Cell : DEN-3 | 7 Participants |
| 5.0 mg of D1ME100 Vaccine | Anti-dengue Antibody and T-cell and B-cell Responders | B-Cell : DEN-4 | 8 Participants |
| 5.0 mg of D1ME100 Vaccine | Anti-dengue Antibody and T-cell and B-cell Responders | T-Cell : All | 11 Participants |
| 5.0 mg of D1ME100 Vaccine | Anti-dengue Antibody and T-cell and B-cell Responders | T-Cell : DEN-1 | 11 Participants |
| 5.0 mg of D1ME100 Vaccine | Anti-dengue Antibody and T-cell and B-cell Responders | T-Cell : DEN-2 | 6 Participants |
| 5.0 mg of D1ME100 Vaccine | Anti-dengue Antibody and T-cell and B-cell Responders | T-Cell : DEN-3 | 6 Participants |