At a glance
ClinicalIndex Comparison Record- ✓Age 18-45 years inclusive at informed consent
- ✓Healthy as established by medical history and clinical examination
- ✓BMI ≤35.0 kg/m²
- ✓Adequate venous access for phlebotomies
- ✕History of allergic reaction or intolerance to quinolone antimicrobials or medical conditions contraindicating ciprofloxacin use (vascular disorders, tendon disorders, Marfyn/Ehlers-Danlos syndrome, QT prolongation, seizures, peripheral neuropathy)
- ✕History of allergic reaction or intolerance to tetracycline antibiotics or medical conditions contraindicating doxycycline use (C. difficile risk, increased BUN, photosensitivity)
- ✕History of anthrax disease, suspected anthrax exposure, or prior anthrax vaccination
- ✕Prior military service after 1990 or planned military enlistment during study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Drug-Vaccine Interaction Study to Examine Whether Co-administering AV7909 With Ciprofloxacin or Doxycycline Affects Antibiotic Pharmacokinetics or AV7909 Immunogenicity in Healthy Adults
In Brief
A Phase 2 clinical trial evaluating Ciprofloxacin 500Mg Tablet, Doxycycline 100Mg Tablet, and 1 other intervention for Anthrax. Completed, enrolled 210 participants across 4 sites.
Detailed Summary
This study is designed to evaluate the pharmacokinetic (PK) profiles of ciprofloxacin or doxycycline when administered orally, prior to, and following, the intramuscular (IM) administration of a two-dose schedule of AV7909 administered two weeks apart.
Study Details
Timeline
Interventions
Ciprofloxacin 500mg administered by mouth every 12 hours. The antibiotic will be administered orally on Study Days 4-9, 22-24 and 31-37.
Doxycycline 100mg administered by mouth every 12 hours. The antibiotic will be administered orally on Study Days 2-9, 22-24 and 32-38.
0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose.The vaccine will be administered intramuscularly on Study Days 8 and 23.