Velocity 2: An Anthrax Vaccine and Antibiotics Clinical Study
Condition: Anthrax
MeSH terms: Anthrax
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      This is a Phase 2, open-label, multicenter, randomized trial designed to evaluate the
      pharmacokinetic profile, immunogenicity, and safety of AV7909 and ciprofloxacin or
      doxycycline when administered concomitantly in healthy adults for an indication of
      post-exposure prophylaxis (PEP) of anthrax.

      Healthy adults between 18 to 45 years of age (inclusive) will sign and date an informed
      consent form and then be screened for eligibility for participation in the study 2 to 28 days
      prior to randomization. Participants meeting the entry criteria will be randomized 1:1:1 to
      one of the three study groups (AV7909 + ciprofloxacin, AV7909 + doxycycline and AV7909 only)
      on Day 1.

      Subjects randomized into Groups 1 & 2 will be assigned to subgroups. Subgroup A will be
      assigned to the antibiotic PK treatment group first, while subgroup B will be assigned to the
      antibiotic non-PK treatment group.

      Participants will be evaluated for safety through Day 51 [or the early withdrawal visit
      (EWV)], as assessed by clinical laboratory tests (hematology, serum chemistry, and
      urinalysis), monitoring of Adverse Events (AEs) including Serious Adverse Events (SAEs) and
      Adverse Events of Special Interest (AESIs), vital signs, and physical examinations. Adverse
      Events of Special Interest are adverse events associated with autoimmune disease as defined
      by the Center for Biologics Evaluation and Research, and might represent a safety signal for
      vaccine-associated autoimmunity. Reactogenicity (solicited systemic and injection site
      reactions) will be assessed daily by the participants using electronic diaries (e-diaries)
      after each vaccination. The e-diary will also be used to record self-administration of
      antibiotics for applicable study groups.

      Information on the use of medications will be collected at each study visit. In addition,
      blood samples for auto-antibody assessment will be taken at Day 1 pre-dose and Day 51 (or
      Early Withdrawal Visit).

      Participants who receive at least one dose of vaccine will also be asked to participate in
      safety follow-up phone calls occurring on Month 3, Month 6, Month 9, and Month 12 (nominally
      3, 6, 9, and 12 months after the last vaccination) to collect information on AEs, SAEs and
      any potential AESIs. Based on responses at these phone contacts, participants may be asked to
      return to the clinic for an unscheduled visit to provide blood samples for auto-antibody
      testing to investigate reports of potential AESIs.

      Independent safety oversight will be provided by a Data Safety Monitoring Board, which will
      be notified of significant AEs, potential AEsIs, or any other events as determined by the
      Medical Monitor, on an ongoing basis.
    

Intervention name(s): Ciprofloxacin 500Mg Tablet; Doxycycline 100Mg Tablet; AV7909
Intervention type(s): Drug; Drug; Biological
Intervention description(s): 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.
Intervention MeSH terms: Doxycycline; Ciprofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Antibiotics; Pharmacokinetics; Vaccine; Ciprofloxacin; Doxycycline; CPG 7909; Bacillus anthracis; Anthrax Vaccine Adsorbed; Post-exposure Prophylaxis; Adjuvant