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Dengue DiseasePhase 1TVDVNCT01502358

Evaluation of the Safety and the Ability of a DNA Vaccine to Protect Against Dengue Disease

A Phase 1 study testing Tetravalent Dengue Vaccine (TVDV), Tetravalent Dengue Vaccine (TVDV) with Vaxfectin® (low-dose) and Tetravalent Dengue Vaccine TVDV with Vaxfectin® (High Dose) in people with Dengue Disease and Dengue Fever, run by U.S. Army Medical Research and Development Command at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether a new investigational dengue vaccine is safe, well-tolerated, and to see if an immune response against dengue disease will be generated. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Dengue Disease, Dengue Fever
What is being tested?
Tetravalent Dengue Vaccine (TVDV), Tetravalent Dengue Vaccine (TVDV) with Vaxfectin® (low-dose) and Tetravalent Dengue Vaccine TVDV with Vaxfectin® (High Dose)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
Dec 2011to Dec 2013
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Male or female age 18 to 50 (inclusive) years old at the time of enrollment
  • Have negative anti-dengue, Japanese encephalitis, West Nile, and yellow fever ELISA serological tests
  • Be informed of the nature of the study and provide written informed consent
  • If the subject is of child-producing potential, he/she agrees to practice adequate birth control or abstain from sex
  • Have access to the WRAIR Clinical Trials for at least 270 days, and be willing to refrain from participation in other investigational clinical trials
  • Be in good general health
Show all 19Show fewer
  • Exclusion Criteria-Subjects meeting any of the following criteria will be excluded from the study:
  • History of Flavivirus infection or history of Flavivirus vaccine (experimental or licensed product) including Japanese encephalitis, yellow fever, and dengue
  • Have a known or suspected hypersensitivity or adverse reaction to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain
  • Have received a live-attenuated vaccine within 42 days prior to the initial injection on Day 0 or a subunit or killed vaccine within 30 days of the initial injection on Day 0
  • Have a positive screen for hepatitis B surface antigen (HBsAg), hepatitis C antibody, or HIV antibody
  • Are pregnant or breastfeeding
  • Have donated or received blood, blood products, or plasma within 30 days prior to Day 0
  • Have any acute illness, including an oral body temperature >100.4°F, within 7 days before the initial injection on Day 0
  • Have a past or current history of malignant disease except for adequately treated skin cancer
  • Exclusions include but are not limited to conditions pertaining to or evidence of immunodeficiency; allergies requiring treatment with antigen injections; autoimmune disease; severe migraine headaches; unstable asthma; clinically significant cardiac arrhythmias, diabetes mellitus, thyroid disease, a bleeding disorder or a seizure disorder.
  • Have participated in an investigational drug, vaccine, or device study within a period of 30 days prior to Day 0;
  • History of splenectomy
  • Planned travel to dengue endemic areas during the study period

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Walter Reed Army Institute of Research and Clinical Trial Center (WRAIR CTC)

    Silver Spring, Maryland, 20702

Other trials in United States

About this study

Official title: A Phase 1 Study To Evaluate The Safety, Tolerability, and Immunogenicity of a Tetravalent Dengue (Serotype 1, 2, 3, and 4) Plasmid DNA Vaccine (TVDV) Formulated With and Without Vaxfectin®

The purpose of this study is to determine whether a new investigational dengue vaccine is safe, well-tolerated, and to see if an immune response against dengue disease will be generated.

Read the detailed description

Arguably the need for a tetravalent dengue vaccine that will effectively induce immunity against all four dengue serotypes has never been greater. Currently, several different approaches are being taken to develop a protective tetravalent dengue vaccine. These include live-attenuated vaccines derived by serial passage in tissue culture, live chimeric vaccines, recombinant protein vaccines and DNA vaccines. While live attenuated and live chimeric vaccines have shown promise in clinical trials, viral competition with suspected immune interference resulting in imbalanced immune responses and reactogenicity with the occurrence of dengue like symptoms remains a concern. It is imperative that any candidate vaccine produce solid immunity against each of the four dengue virus serotypes. Failure to do so may place the recipient of the vaccine at risk for developing severe dengue disease (dengue hemorrhagic fever/dengue shock syndrome) following exposure to the virus serotype to which there was incomplete protective immunity, resulting in antibody dependent enhancement due to the presence of non-neutralizing anti-dengue antibodies.

Being tested
Tetravalent Dengue Vaccine (TVDV), Tetravalent Dengue Vaccine (TVDV) with Vaxfectin® (low-dose), Tetravalent Dengue Vaccine TVDV with Vaxfectin® (High Dose)
Keywords
dengue, dengue fever, dengue disease, tetravalent dengue vaccine, Vaxfectin®
Medical subject headings
Dengue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tetravalent Dengue Vaccine (TVDV)Biological

    Low dose delivered intramuscularly on Study Days 0, 30 and 90

  • Tetravalent Dengue Vaccine (TVDV) with Vaxfectin® (low-dose)Biological

    Low dose: TVDV formulated with Vaxfectin®; 1.0 mL volume delivered intramuscularly on Study Days 0, 30 and 90

  • Tetravalent Dengue Vaccine TVDV with Vaxfectin® (High Dose)Biological

    High dose: TVDV formulated with Vaxfectin®; 1.0 mL volume delivered intramuscularly on Study Days 0, 30 and 90

Study groups in NCT01502358
Study groupRoleWhat they receive
Tetravalent Dengue Vaccine (TVDV)Experimentallow dose (no adjuvant)
Receives: Biological: Tetravalent Dengue Vaccine (TVDV)
Tetravalent Dengue Vaccine (TVDV) with Vaxfectin® (low-dose)Experimentallow dose (with adjuvant)
Receives: Biological: Tetravalent Dengue Vaccine (TVDV) with Vaxfectin® (low-dose)
Tetravalent dengue Vaccine (TVDV) with Vaxfectin® (high-dose)Experimentalhigh dose (with adjuvant)
Receives: Biological: Tetravalent Dengue Vaccine TVDV with Vaxfectin® (High Dose)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events (AEs) or serious adverse events (SAEs)

    All AEs and SAEs will be recorded during the entire duration of the study, or up to 360 days.

    Measured: Up to Day 360

Secondary outcomes (3)

  1. Percent of subjects (in each group) achieving tetravalent ELISA IgM seroconversion

    From date of first vaccine dose until seroconversion is achieved, up to 360 days.

    Measured: Days 0-360

  2. Percent of subjects (in each group) achieving tetravalent seroconversion, by dengue plaque reduction MN50 titer

    From date of first vaccine dose until seroconversion is achieved, up to 360 days.

    Measured: Days 0-360

  3. MN50 titer 1 month (Study Day 120) and Study Days 180 and 270 after vaccine regimen is complete

    Measured: Following completion of study days 120 and 180 and 270 days after vaccine regimen is complete

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01502358
Sponsor's protocol ID
S-11-0007
Other IDs
WRAIR #1839, NMRC 2011.0012, A-16892
Acronym
TVDV
Status last verified
Apr 2015
First submitted
15 Dec 2011
Last updated
4 Nov 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tetravalent Dengue Vaccine (TVDV), Tetravalent Dengue Vaccine (TVDV) with Vaxfectin® (low-dose) and Tetravalent Dengue Vaccine TVDV with Vaxfectin® (High Dose) in people with Dengue Disease and Dengue Fever, 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 19 inclusion and 0 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 4 Nov 2016. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of participants with adverse events (AEs) or serious adverse events (SAEs) (time frame: Up to Day 360). 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 NCT01502358.

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 4 Nov 2016; AzTrials last refreshed its copy on 8 Nov 2026.

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