DenguePhase 1NCT00290147
Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine
A Phase 1 study testing D1ME100 (dengue-1 premembrane/envelope DNA vaccine) in people with Dengue, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
The purpose of this study is to exame the safety of a DNA vaccine against dengue-1. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue
- What is being tested?
- D1ME100 (dengue-1 premembrane/envelope DNA vaccine)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Apr 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Available to participate for the duration of the study (approximately 12 months)
- Completion and review of knowledge assement quiz
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Institute of Research, Bldg 503
Silver Spring, Maryland, 20910
About this study
Official title: An Open-Label, Dose Escalation, Phase I Safety, and Immunogenicity Trial of a Dengue Serotype 1 (DEN-1) Premembrane (prM) and Envelope (E) DNA Vaccine (D1ME100) in Healthy Adults Volunteers
The purpose of this study is to exame the safety of a DNA vaccine against dengue-1.
Read the 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.
- Conditions
- Dengue
- Being tested
- D1ME100 (dengue-1 premembrane/envelope DNA vaccine)
- Keywords
- Dengue, DNA vaccine
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D1ME100 (dengue-1 premembrane/envelope DNA vaccine)Biological
IM injection delivered by Biojector
| Study group | Role | What they receive |
|---|---|---|
| 1.0 mg of D1ME100 vaccine | Experimental | 1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months Receives: Biological: D1ME100 (dengue-1 premembrane/envelope DNA vaccine) |
| 5.0 mg of D1ME100 vaccine | Experimental | 5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months Receives: Biological: D1ME100 (dengue-1 premembrane/envelope DNA vaccine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic and Local Reactogenicity Rates for Ungraded Symptoms
Summary of ungraded systemic and local reactogenicity symptoms following each vaccination
Measured: Months 0, 1 and 5
Secondary outcomes (1)
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionDec 2006
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DengueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- United States Army Medical Materiel Development Activity
- Responsible party
- Sponsor
- Investigators
- Charmagne Beckett, MD, Principal investigator, Naval Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290147
- Sponsor's protocol ID
- NMRC 2004.0002
- Other IDs
- WRAIR 1191, HSRRB A-13304, 62787A 810S A0235
- Status last verified
- May 2017
- First submitted
- 9 Feb 2006
- Last updated
- 20 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Danko JR, Kochel T, Teneza-Mora N, Luke TC, Raviprakash K, Sun P, Simmons M, Moon JE, De La Barrera R, Martinez LJ, Thomas SJ, Kenney RT, Smith L, Porter KR. Safety and Immunogenicity of a Tetravalent Dengue DNA Vaccine Administered with a Cationic Lipid-Based Adjuvant in a Phase 1 Clinical Trial. Am J Trop Med Hyg. 2018 Mar;98(3):849-856. doi: 10.4269/ajtmh.17-0416. Epub 2018 Jan 18.
PubMed 29363446Beckett CG, Tjaden J, Burgess T, Danko JR, Tamminga C, Simmons M, Wu SJ, Sun P, Kochel T, Raviprakash K, Hayes CG, Porter KR. Evaluation of a prototype dengue-1 DNA vaccine in a Phase 1 clinical trial. Vaccine. 2011 Jan 29;29(5):960-8. doi: 10.1016/j.vaccine.2010.11.050. Epub 2010 Nov 25.
PubMed 21111785
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose Escalation, Phase I Safety, and Immunogenicity Trial of a Dengue Serotype 1 (DEN-1) Premembrane (prM) and Envelope (E) DNA Vaccine (D1ME100) in Healthy Adults Volunteers
- ClinicalTrials.gov ID
- NCT00290147
- Acronym / sponsor ID
- NMRC 2004.0002
- Conditions
- Dengue
- Keywords
- Dengue, DNA vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- United States Army Medical Materiel Development Activity
- Study start
- Jan 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 10 Feb 2006 (estimated)
- Results
- Posted 14 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.0 mg of D1ME100 vaccine | Experimental | Biological: D1ME100 (dengue-1 premembrane/envelope DNA vaccine)1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months |
| 5.0 mg of D1ME100 vaccine | Experimental | Biological: D1ME100 (dengue-1 premembrane/envelope DNA vaccine)5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Available to participate for the duration of the study (approximately 12 months)
- Completion and review of knowledge assement quiz
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D1ME100 (dengue-1 premembrane/envelope DNA vaccine)IM injection delivered by Biojector | Biological | 1.0 mg of D1ME100 vaccine, 5.0 mg of D1ME100 vaccine |
Primary outcome
Systemic and Local Reactogenicity Rates for Ungraded Symptoms
Time frame: Months 0, 1 and 5
Summary of ungraded systemic and local reactogenicity symptoms following each vaccination
1 secondary outcome
Anti-dengue Antibody and T-cell and B-cell Responders
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29363446Danko JR, Kochel T, Teneza-Mora N, Luke TC, Raviprakash K, Sun P, Simmons M, Moon JE, De La Barrera R, Martinez LJ, Thomas SJ, Kenney RT, Smith L, Porter KR. Safety and Immunogenicity of a Tetravalent Dengue DNA Vaccine Administered with a Cationic Lipid-Based Adjuvant in a Phase 1 Clinical Trial. Am J Trop Med Hyg. 2018 Mar;98(3):849-856. doi: 10.4269/ajtmh.17-0416. Epub 2018 Jan 18.
- Derived from this study: PubMed 21111785Beckett CG, Tjaden J, Burgess T, Danko JR, Tamminga C, Simmons M, Wu SJ, Sun P, Kochel T, Raviprakash K, Hayes CG, Porter KR. Evaluation of a prototype dengue-1 DNA vaccine in a Phase 1 clinical trial. Vaccine. 2011 Jan 29;29(5):960-8. doi: 10.1016/j.vaccine.2010.11.050. Epub 2010 Nov 25.
- Individual participant dataSharing planned: No
Related trials for Dengue
Active, not recruitingPhase 3
A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)
Healthy
RecruitingPhase 1
Phase 1 Challenge Study Using rDEN2delta30-7169 to Evaluate Host-Pathogen Interactions in Primary, Homotypic, and Heterotypic Dengue Virus Infection
Healthy Volunteers, Dengue
Active, not recruiting
A Controlled Human Infection Model of Dengue
Dengue
RecruitingPhase 2/3
Emetine for Viral Outbreaks (a.k.a. EVOLVE Antiviral Initiative)
Dengue
RecruitingPhase 2
Adaptive Dengue Antiviral Platform Trial
Dengue, Antiviral Drugs
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charmagne Beckett, MD principal investigator
Naval Medical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing D1ME100 (dengue-1 premembrane/envelope DNA vaccine) in people with Dengue, run by U.S. Army Medical Research and Development Command at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic and Local Reactogenicity Rates for Ungraded Symptoms (time frame: Months 0, 1 and 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00290147, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017.