Conditions: Anthrax
Keywords: post-exposure prophylaxis toxin neutralization assay
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 154
Healthy volunteers: yes

Brief summary:
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)

Detailed description:
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.

Arms:
arm 1: BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule.

Ciprofloxacin: 500 mg twice a day (Days 1-6, 19-21, 33-35, 40-48). arm 2: BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule.

Ciprofloxacin: 500 mg twice a day (Days 1-6, 19-21, 33-35, 40-48). arm 3: BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule.

Interventions: intervention 1: BioThrax intervention 2: Ciprofloxacin
Intervention descriptions: intervention 1: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule intervention 2: 500 mg twice a day (Days 1-6, 19-21, 33-35, 40-48).

Protocol document: