Signed written informed consent.
Age 18 to 65.
Normal and healthy (immune competent) as determined by medical history, physical exam, vital signs and clinical laboratory tests during the screening period.
If all lab results for quantitative IgA immunoglobulin level are lower than 15% below normal range, the subject may not proceed further in the screening process.
Subject must meet all required subject suitability criteria that pertain to normal source plasma donors.
Negative HIV serology during screening period.
Subject must have been previously immunized for smallpox, at =3 years prior to commencement of screening assessments, and vaccination history must be confirmed by oral or written history and the presence of a visible pathognomonic smallpox vaccination scar.
Female subjects of childbearing potential must agree to use highly effective birth control methods.

NCT02443623_inc_T2
Person
Age
NCT02443623_inc_T3
Value
18 to 65
NCT02443623_inc_T4
Qualifier
Normal
NCT02443623_inc_T5
Qualifier
healthy
NCT02443623_inc_T6
Temporal
during the screening period
NCT02443623_inc_T7
Reference_point
screening period
NCT02443623_inc_T8
Observation
medical history
NCT02443623_inc_T9
Procedure
physical exam
NCT02443623_inc_T10
Measurement
vital signs
NCT02443623_inc_T11
Measurement
clinical laboratory tests
NCT02443623_inc_T12
Scope
medical history, physical exam, vital signs and clinical laboratory tests
NCT02443623_inc_T13
Measurement
quantitative IgA immunoglobulin level
NCT02443623_inc_T14
Value
lower than 15% below normal range
NCT02443623_inc_T17
Measurement
HIV serology
NCT02443623_inc_T18
Value
Negative
NCT02443623_inc_T19
Temporal
during screening period
NCT02443623_inc_T20
Reference_point
screening period
NCT02443623_inc_T21
Condition
smallpox
NCT02443623_inc_T22
Procedure
immunized
NCT02443623_inc_T23
Temporal
3 years prior to commencement of screening assessments
NCT02443623_inc_T24
Reference_point
commencement of screening assessments
NCT02443623_inc_T26
Person
Female
NCT02443623_inc_T27
Condition
childbearing potential
NCT02443623_inc_T28
Procedure
birth control methods