Clinical Trial: Safety and Immunogenicity of Q Fever Vaccine

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Evaluation of the Safety and Immunogenicity of Q Fever Vaccine, Phase I, Inactivated, Dried, NDBR 105, in Subjects at Risk of Exposure to Coxiella Burnetii

Brief Summary: The purpose of this study is to evaluate the safety of Q Fever Vaccine, Phase I, Inactivated, Dried, NDBR 105 and collect data on incidence of occupational Q fever infection in vaccinated personnel.

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

Current Primary Outcome:

  • Change in Immunogenicity [ Time Frame: Day 28, Day 56, or 6 months ]
    Immune response will be evaluated for per protocol subjects to determine the percentage of subjects who experience a ≥ fourfold rise in immunofluorescence assay (IFA) antibody titer after vaccination. Immunoglobulin M (IgM) at Day 28 or Day 56, or immunoglobulin G (IgG) at 6 months.
  • Percentage of subjects with symptoms following Q fever vaccination [ Time Frame: 6 months ]
  • Percentage of subjects with erythema following Q fever vaccination along with severity and association with vaccination [ Time Frame: 6 months ]
  • Percentage of subjects with induration following Q fever vaccination along with severity and association with vaccination [ Time Frame: 6 months ]
  • Percentage of subjects with each AE, system organ class of AE, severity, and association with vaccination [ Time Frame: 6 months ]
  • Percentage of subjects with symptoms following Q fever skin test antigen [ Time Frame: 6 months ]
  • Percentage of subjects with erythema following Q fever skin test antigen along with severity and association with skin test antigen [ Time Frame: 6 months ]
  • Percentage of subjects with induration following Q fever skin test antigen along with severity and association with skin test antigen [ Time Frame: 6 months ]
  • Percentage of subjects with each AE, system organ class of AE, severity, and association with skin test antigen [ Time Frame: 6 months ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: U.S. Army Medical Research and Materiel Command

    Dates:
    Date Received: March 17, 2014
    Date Started: February 2006
    Date Completion: December 2019
    Last Updated: November 9, 2016
    Last Verified: August 2016