The purpose of this clinical trial is to determine whether there is any effect on the antibiotic, ciprofloxacin when taken before and after administration of a 3-dose series of BioThrax® (Anthrax Vaccine Adsorbed or AVA). This study will be conducted in the United States (US) in 154 healthy male and female volunteer subjects ages 18 to 45. The duration of study participation for each subject will be approximately 76 days (approximately 2.5 months)
BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection. This is a randomized, open-label, Phase 2, multi-center trial to investigate the potential interactions of ciprofloxacin and BioThrax.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
154
route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
500 mg twice a day (Days 1-6, 19-21, 33-35, 40-48).
The Center for Pharmaceutical Research
Kansas City, Missouri, United States
Meridian Clinical Research
Omaha, Nebraska, United States
Research Across America
Dallas, Texas, United States
Ratios of Ciprofloxacin Area Under the Curve and Cmax (Day 5/Day 44)
Ratios of Area Under the Curve from zero to 12 hours (AUC0-12h) and maximum concentration (Cmax) achieved for ciprofloxacin (Day 5/Day 44).
Time frame: Day 5 and Day 44 in Arm 1
Geometric Mean Titer (GMT) of Toxin Neutralizing Antibody (TNA) Levels
Blood was collected in arms 1 and 2 at day 48 ( 2 weeks following last vaccination) and in arm 3 at day 43 ( 2 weeks following last vaccination) for TNA assay to determine the NF50 antibody titer for calculating GMT.
Time frame: Two weeks after last vaccination
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