This study seeks to determine the safety and immunogenicity of a series of 3 primary vaccinations and a booster vaccination of Recombinant ricin toxin A-chain 1-33/44-198 (rRTA 1-33/44-198) vaccine (RVEc) at 10 or 20 μg intradermally (ID). This study is evaluating if RVEc will display an acceptable safety profile as determined by adverse event (AE) data and if RVEc will elicit anti-ricin antibody titers and ricin toxin-neutralizing antibodies in vaccine recipients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
The composition of the final drug product, prior to any dilution, is 0.2 mg recombinant ricin toxin 1-33/44-198 (RVEc) in buffer and 0.2% Alhydrogel® at a final volume of 1 mL per vial
Department of Clinical Research, USAMRIID
Fort Deterick, Maryland, United States
Percentage of vaccinated subjects without adverse events by Day 730
Adverse events will be evaluated for subjects in the assessment population on vaccination days and at follow-up time points.
Time frame: Day 730
Percentage of vaccinated subjects with adverse events by Day 730
Adverse events will be evaluated for subjects in the assessment population on vaccination days and at follow-up time points.
Time frame: Day 730
Percentage of vaccinated subjects with any severity of local reactions (Grades 1-4) by Day 730
Adverse events will be evaluated for subjects in the assessment population on vaccination days and at follow-up time points.
Time frame: Day 730
Percentage of vaccinated subjects with system reactions of any severity (Grades 1-4) by Day 730
Adverse events will be evaluated for subjects in the assessment population on vaccination days and at follow-up time points.
Time frame: Day 730
Percentage of vaccinated subjects with generalized allergic reactions by Day 730
Adverse events will be evaluated for subjects in the assessment population on vaccination days and at follow-up time points.
Time frame: Day 730
Percentage of vaccinated subjects with each adverse event by Day 730
Adverse events will be evaluated for subjects in the assessment population on vaccination days and at follow-up time points.
Time frame: Day 730
Total anti-ricin immunoglobulin G (IgG) antibody titers as determined by ELISA
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Time frame: Days 0, 14, 28, 42, 56, 106, 120, 134, 180, 270, 365, 379, 393, 455, 555, 730
Anti-ricin toxin-neutralizing antibody titers as determined by the colorimetric toxin neutralization assay (TNA)
Time frame: Days 0, 14, 28, 42, 56, 106, 120, 134, 180, 270, 365, 379, 393, 455, 555, 730