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A Study of Two Doses of WRAIR Dengue Vaccine Administered Six Months Apart to Healthy Adults and Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00468858
First Posted: May 3, 2007
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
Results First Submitted: February 8, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions: Dengue Fever
Dengue Hemorrhagic Fever
Dengue Shock Syndrome
Interventions: Other: Placebo
Biological: T-DEN-Post-Transfection F17
Biological: T-DEN-Post-Transfection F19

  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
No text entered.

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
T-DEN-Post-Transfection F17

Post-Transfection F17, full dose

T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

T-DEN-Post-Transfection F19

Post-Transfection F19, full dose

T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

Placebo

Control

Placebo: Lyophilized, single dose vials and sterile water for

> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months


Participant Flow:   Overall Study
    T-DEN-Post-Transfection F17   T-DEN-Post-Transfection F19   Placebo
STARTED   211   212   213 
COMPLETED   202   202   199 
NOT COMPLETED   9   10   14 
Adverse Event                0                1                0 
Withdrawal by Subject                7                4                5 
Relocation                1                3                3 
Lost to Follow-up                1                2                5 
Other                0                0                1 



  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
T-DEN-Post-Transfection F17

Post-Transfection F17, full dose

T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

T-DEN-Post-Transfection F19

Post-Transfection F19, full dose

T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

Placebo

Control

Placebo: Lyophilized, single dose vials and sterile water for

> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months

Total Total of all reporting groups

Baseline Measures
   T-DEN-Post-Transfection F17   T-DEN-Post-Transfection F19   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 211   212   213   636 
Age 
[Units: Years]
Mean (Standard Deviation)
 13.8  (14.10)   12.8  (12.51)   13.6  (13.89)   13.4  (13.50) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      107  50.7%      114  53.8%      114  53.5%      335  52.7% 
Male      104  49.3%      98  46.2%      99  46.5%      301  47.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      210  99.5%      212 100.0%      213 100.0%      635  99.8% 
Not Hispanic or Latino      1   0.5%      0   0.0%      0   0.0%      1   0.2% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
       
Race         
African heritage / African American      2   0.9%      1   0.5%      2   0.9%      5   0.8% 
American      0   0.0%      1   0.5%      2   0.9%      3   0.5% 
Dominican      2   0.9%      2   0.9%      1   0.5%      5   0.8% 
Hispanic      0   0.0%      1   0.5%      1   0.5%      2   0.3% 
Mixed      9   4.3%      7   3.3%      10   4.7%      26   4.1% 
Peruvian      1   0.5%      0   0.0%      0   0.0%      1   0.2% 
Puerto Rican      164  77.7%      166  78.3%      164  77.0%      494  77.7% 
White-Arabic / North African heritage      1   0.5%      0   0.0%      1   0.5%      2   0.3% 
White - Caucasian / European heritage      32  15.2%      34  16.0%      32  15.0%      98  15.4% 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
Puerto Rico   211   212   213   636 


  Outcome Measures
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1.  Primary:   Safety: Incidence of All and Grade 3 Solicited Local Symptoms   [ Time Frame: Within 21 days (days 0-20) f/up period after each vaccine dose ]

2.  Primary:   Safety: Summary of Unsolicited Adverse Events Within the 31-day Post-vaccination Period   [ Time Frame: Within the 31-day (days 0-30) follow-up period after each vaccine dose ]

3.  Primary:   Safety: Occurrence of Serious Adverse Events (SAEs)   [ Time Frame: 6 months + 30 day follow-up period after last vaccine dose ]

4.  Secondary:   Incidence of Suspected and Laboratory Confirmed Dengue   [ Time Frame: 31-day (days 0-30) post-vaccination period and after 31-day period ]

5.  Secondary:   GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects   [ Time Frame: at month 7 (one month post dose 2) ]

6.  Secondary:   Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes   [ Time Frame: Pre-vaccination, at post dose 1, months 3 and 6 and post dose 2, month 7 ]

7.  Secondary:   Percent of Subjects With Neut. Sero-response to Each DEN Serotype   [ Time Frame: Pre-accination, at post dose 1, months 3 and 6 and post dose 2, month 7 ]

8.  Secondary:   Vaccine Response to DEN Antibody at Post Dose 1, Month 3   [ Time Frame: at month 3, post dose 1 ]

9.  Secondary:   Vaccine Response to DEN Antibody at Post Dose 2, Month 7   [ Time Frame: at month 7, post dose 2 ]


  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
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  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: Faina Rose, PhD
Organization: GSK
phone: 610-664-8986
e-mail: faina.v.rose@gsk.com


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: NCT00468858     History of Changes
Other Study ID Numbers: A-14040
WIRB number 20070071 ( Other Identifier: Western Institutional Review Boards (WIRB) )
106405 ( Other Identifier: GSK )
T-DEN-003 ( Other Identifier: MRMC/WRAIR )
First Submitted: May 1, 2007
First Posted: May 3, 2007
Results First Submitted: February 8, 2017
Results First Posted: June 6, 2017
Last Update Posted: July 2, 2017