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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Subcutaneous 0.5 mL Q fever Vaccine, Phase I, Inactivated, Dried, NDBR 105
Special Immunizations Program, Division of Medicine, USAMRIID
Fort Deterick, Maryland, United States
Change in Immunogenicity
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.
Time frame: Day 28, Day 56, or 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
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