Clinical Trial: Assessment of a Dengue-1-Virus-Live Virus Human Challenge - (DENV-1-LVHC) Virus Strain

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase One, Open Label, Assessment of a Dengue-1-Virus-Live Virus Human Challenge - (DENV-1-LVHC) Virus Strain

Brief Summary: To evaluate the effectiveness of candidate dengue vaccine formulations, it is prudent to develop an appropriate challenge model. To this end, this first-in-human study will examine the safety and effectiveness of the Dengue 1 Live Virus Human Challenge (DENV-1-LVHC) product and assess the ability of this virus strain to elicit an uncomplicated dengue-like illness.

Detailed Summary:
Sponsor: U.S. Army Medical Research and Materiel Command

Current Primary Outcome:

• Number of Abnormal Laboratory Measurements [ Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later ]
• Intensity of Abnormal Laboratory Measurements [ Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later ]
• Duration of Abnormal Laboratory Measurements [ Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later ]
• Occurrence of Solicited Injection Site Symptoms [ Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later ]
• Intensity of Solicited Injection Site Symptoms [ Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later ]
• Duration of Solicited Injection Site Symptoms [ Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later ]
• Occurrence of unsolicited Injection Site Symptoms [ Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later ]
• Intensity of Unsolicited Injection Site Symptoms [ Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later ]
• Duration of Unsolicited Injection Site Symptoms [ Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later ]
• Occurrence of Solicited Systemic Symptoms [ Time Frame: 28 days post virus inoculation or 7 days post hospitalization, wh
  
  

  Original Primary Outcome:

  • Number of Abnormal Laboratory Measurements [ Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later ]
  • Intensity of Abnormal Laboratory Measurements [ Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later ]
  • Duration of Abnormal Laboratory Measurements [ Time Frame: 28 days post virus inoculaiton or 7 days post hospitalization, whichever is later ]
  • Occurrence of Solicited Injection Site Symptoms [ Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later ]
  • Intensity of Solicited Injection Site Symptoms [ Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later ]
  • Duration of Solicited Injection Site Symptoms [ Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later ]
  • Occurrence of unsolicited Injection Site Symptoms [ Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later ]
  • Intensity of Unsolicited Injection Site Symptoms [ Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later ]
  • Duration of Unsolicited Injection Site Symptoms [ Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later ]
  • Occurrence of Solicited Systemic Symptoms [ Time Frame: 28 days post virus inoculation or 7 days post hospitalization, wh
    
    

    Current Secondary Outcome:

    • Incubation period before onset of fever [ Time Frame: Up to 28 days post virus inoculation ]
    • Viremia by Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) [ Time Frame: Up to 28 days post virus inoculation ]
    • Occurrence of fever without other identifiable cause, such as strep throat or influenza [ Time Frame: Up to 28 days post virus inoculation ]
      The occurrence of fever defined as greater than or equal to 38°C (100.4° F) measured at least 2 times in 24 hours but not lasting more than 96 hours up to 28 days post virus inoculation without other identifiable cause, such as strep infection or influenza.
    • Occurrence of Headache [ Time Frame: Up to 28 days post virus inoculation ]
    • Grade of Headache [ Time Frame: Up to 28 days post virus inoculation ]
    • Occurrence of Myalgia [ Time Frame: Up to 28 days post virus inoculation ]
    • Grade of Myalgia [ Time Frame: Up to 28 days post virus inoculation ]
    • Occurrence of Rash [ Time Frame: Up to 28 days post virus inoculation ]
    • Grade of Rash [ Time Frame: Up to 28 days post virus inoculation ]
    • Occurrence of Liver Function Tests Abnormalities [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)] [ Time Frame: Up to 28 days post virus inoculation ]
    • Grade of Liver Function Tests Abnormalities [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)] [ Time Frame: Up to 28 days post virus inoculation ]
    • Occurrence of Leukopenia [ Time Frame: Up to 28 days post virus inoculation ]
    • Grade of Leukopenia [ Time Frame: Up to 28 days post virus inoculation ]
    • Occurrence of Thrombocytopenia [ Time Frame: Up to 28 days post virus inoculation ]
    • Grade of Thrombocytopenia [ Time Frame: Up to 28 days post virus inoculation ]
    
    
    

    Original Secondary Outcome: Same as current
    
    Information By: U.S. Army Medical Research and Materiel Command
    

    Dates:
    Date Received: February 10, 2015
    Date Started: October 2015
    Date Completion: January 2019
    Last Updated: April 5, 2017
    Last Verified: April 2017