NCT04067011

Velocity 2: An Anthrax Vaccine and Antibiotics Clinical Study

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Emergent BioSolutions · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Anthrax

Interventions

Type	Name	Description
DRUG	Ciprofloxacin 500Mg Tablet	Ciprofloxacin 500mg administered by mouth every 12 hours. The antibiotic will be administered orally on Study Days 4-9, 22-24 and 31-37.
DRUG	Doxycycline 100Mg Tablet	Doxycycline 100mg administered by mouth every 12 hours. The antibiotic will be administered orally on Study Days 2-9, 22-24 and 32-38.
BIOLOGICAL	AV7909	0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose.The vaccine will be administered intramuscularly on Study Days 8 and 23.

Timeline

• Start date: 2019-08-12
• Primary completion: 2020-03-05
• Completion: 2020-03-19
• First posted: 2019-08-26
• Last updated: 2025-09-08
• Results posted: 2021-06-30

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study