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Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine

This study has been completed.
Sponsor:
Collaborator:
United States Army Medical Materiel Development Activity
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00290147
First received: February 9, 2006
Last updated: March 2, 2017
Last verified: March 2017
Results First Received: March 2, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Prevention
Condition: Dengue
Intervention: Biological: D1ME100 (dengue-1 premembrane/envelope DNA vaccine)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
22 healthy adult volunteers enrolled to participate at the Naval Medical Research Center site

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    1.0 mg of D1ME100 Vaccine   5.0 mg of D1ME100 Vaccine
STARTED   10   12 
COMPLETED   10   12 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
   1.0 mg of D1ME100 Vaccine   5.0 mg of D1ME100 Vaccine   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   12   22 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.4  (8.60)   36.9  (9.89)   38.5  (9.28) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  40.0%      3  25.0%      7  31.8% 
Male      6  60.0%      9  75.0%      15  68.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      1   8.3%      1   4.5% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      7  70.0%      8  66.7%      15  68.2% 
White      1  10.0%      2  16.7%      3  13.6% 
More than one race      1  10.0%      0   0.0%      1   4.5% 
Unknown or Not Reported      1  10.0%      1   8.3%      2   9.1% 
Region of Enrollment 
[Units: Participants]
     
United States   10   12   22 
Active Duty Military 
[Units: Participants]
Count of Participants
 0   2   2 
Civilian 
[Units: Participants]
Count of Participants
 10   10   20 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Safety and Reactogenicity of D1ME100   [ Time Frame: 12 months ]

2.  Secondary:   Anti-dengue Antibody and T-cell and B-cell Responders   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Charmagne Beckett, LCDR, MC, USNR
Organization: Naval Medical Research Center, Viral Diseases Department
phone: 301-295-6400
e-mail: charmagne.beckett@med.navy.mil


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00290147     History of Changes
Other Study ID Numbers: NMRC 2004.0002
WRAIR 1191 ( Other Identifier: WRAIR ID )
HSRRB A-13304 ( Other Identifier: IRB )
62787A 810S A0235 ( Other Identifier )
Study First Received: February 9, 2006
Results First Received: March 2, 2017
Last Updated: March 2, 2017