The purpose of this study is to evaluate the safety for up to two doses of NasoShield, to determine if antibodies that protect against anthrax are formed after treatment with NasoShield, and to determine whether the formation of these antibodies are affected by different positions of administration.
After being informed about the study and potential risks, all healthy volunteers that have given written informed consent will undergo screening to determine eligibility for study entry. If the healthy volunteer qualifies for the study, they will be randomly assigned to 1 of 3 treatment groups. Within the treatment group, the participant will be randomized in a double-blind manner in a 5:2 ratio to NasoShield or placebo. The investigational drug (either NasoShield or placebo) will be administered on Days 1 and 29 after qualifying into the study. The position of administration and the amount of time the subject will need to stay in the specified position will depend on the group to which the subject is assigned. Participants will return to the investigational site for multiple visits through Day 210 (approximately 6 months after the second dose). At each visit, the participant will be asked about interim medical history and use of any medications, and safety and immunogenicity assessments will be performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
43
NasoShield is an adenovirus-vectored anthrax vaccine
Normal saline
JBR Clinical Research
Salt Lake City, Utah, United States
Reactogenicity to evaluate the safety of NasoShield
Subjects will record solicited local and systemic events for 7 days after each dose
Time frame: For 7 days after vaccination
Adverse Events (AEs) to evaluate the safety of NasoShield
All adverse events from Day 1 to Day 57; serious adverse events (SAE), medically attended adverse events (MAAE), and new-onset chronic illnesses (NCI) from Day 1 to Day 210
Time frame: From Day 1 to Day 210
Anti-protective antigen (PA) immunoglobulin G (IgG) to evaluate humoral immunogenicity
Titer measured by enzyme-linked immunosorbent assay (ELISA) in serum
Time frame: From Day 1 to Day 210
Toxin neutralization antibody 50% neutralization factor (TNA-NF50) titer measured in serum by cytotoxic assay to evaluate humoral immunogenicity
Time frame: From Day 1 to Day 210
Anti-protective antigen (PA) immunoglobulin A (IgA) to evaluate mucosal immune response
Titer measured by enzyme-linked immunosorbent assay (ELISA) in serum
Time frame: From Day 1 to Day 57
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