Velocity 2: An Anthrax Vaccine and Antibiotics Clinical Study

NCT04067011 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: EBS.AVA.210
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Anthrax

Keywords

Antibiotics; Pharmacokinetics; Vaccine; Ciprofloxacin; Doxycycline; CPG 7909; Bacillus anthracis; Anthrax Vaccine Adsorbed; Post-exposure Prophylaxis; Adjuvant

Outcome Measures

Primary Outcomes (2)

• Ratio of Ciprofloxacin Area Under the Curve From 0 to 12 Hours (AUC0-12h) and Maximum Concentration (Cmax) on Days 8 and 35

  Based on serum concentrations of ciprofloxacin on Day 8 (pre-AV7909 vaccination) and on Day 35 (post-AV7909 vaccination), steady state AUC0-12h and Cmax were derived, and geometric mean of ratio of AUC0-12h on Day35/Day 8 and geometric mean of ratio for Cmax on Day 35/Day8, and the corresponding 90% CI of the mean ratios were calculated.

  Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 and 12 hours post-ciprofloxacin dose on Days 8 (pre-AV7909 vaccination) and 35 (post-AV7909 vaccination)

• Ratio of Doxycycline Area Under the Curve From 0 to 12 Hours (AUC0-12h) and Maximum Concentration (Cmax) on Days 8 and 38

  Based on serum concentrations of doxycycline on Day 8 (pre-AV7909 vaccination) and on Day 38 (post-AV7909 vaccination), steady state AUC0-12h and Cmax were derived, and geometric mean of ratio of AUC0-12h on Day38/Day 8 and geometric mean of ratio for Cmax on Day 38/Day8, and the corresponding 90% CI of the mean ratios were calculated.

  Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 and 12 hours post-doxycycline dose on Days 8 (pre-AV7909 vaccination) and 38 (post-AV7909 vaccination)

Secondary Outcomes (1)

• Geometric Mean TNA 50% Neutralizing Factor (NF50) Values Two Weeks After the Second AV7909 Vaccination (Day 37 ± 1 Day).

  Day 37 ± 1 day

Study Arms (3)

Group 1:Ciprofloxacin + AV7909

EXPERIMENTAL

Participants meeting entry criteria will be randomized 1:1:1 to one of three investigational study groups. Groups 1 to 3 will each receive a manufactured lot of AV7909 per the study visit schedule. Group 1 will concomitantly receive ciprofloxacin.

Drug: Ciprofloxacin 500Mg Tablet; Biological: AV7909

Group 2: Doxycycline +AV7909

EXPERIMENTAL

Participants meeting entry criteria will be randomized 1:1:1 to one of three investigational study groups. Groups 1 to 3 will each receive a manufactured lot of AV7909 per the study visit schedule. Group 2 will concomitantly receive doxycycline.

Drug: Doxycycline 100Mg Tablet; Biological: AV7909

Group 3: AV7909

EXPERIMENTAL

Participants meeting entry criteria will be randomized 1:1:1 to one of three investigational study groups. Groups 1 to 3 will each receive a manufactured lot of AV7909 per the study visit schedule.

Biological: AV7909

Interventions

Ciprofloxacin 500Mg Tablet DRUG

Ciprofloxacin 500mg administered by mouth every 12 hours. The antibiotic will be administered orally on Study Days 4-9, 22-24 and 31-37.

Group 1:Ciprofloxacin + AV7909

Doxycycline 100Mg Tablet DRUG

Doxycycline 100mg administered by mouth every 12 hours. The antibiotic will be administered orally on Study Days 2-9, 22-24 and 32-38.

Group 2: Doxycycline +AV7909

AV7909 BIOLOGICAL

0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose.The vaccine will be administered intramuscularly on Study Days 8 and 23.

Group 1:Ciprofloxacin + AV7909; Group 2: Doxycycline +AV7909; Group 3: AV7909

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent obtained from the participant (dated, signed, and captured in the medical chart at the site).
• A male or female, aged 18 to 45 years of age, inclusive, at the time of informed consent.
• Healthy condition as established by medical history and clinical examination before entering into the study.
• Body mass index (BMI) less than or equal to 35.0 kg/m\^2 at the Screening visit.
• Have adequate venous access for phlebotomies.
• For a woman of childbearing potential (WOCBP), negative pregnancy test at Screening and pre-randomization on Day 1, not currently breastfeeding, and no intention to become pregnant during the study period through 12 months after last receipt of any investigational product (IP). Every female participant is considered to be a WOCBP unless she is surgically sterile (hysterectomy, bilateral salpingectomy or bilateral oophorectomy) OR postmenopausal (defined as \>12 consecutive months without menses and screen follicle-stimulating hormone \> 30 mIU/mL). Women who are not of childbearing potential are allowed to enroll if they are surgically sterile or postmenopausal as defined above.
• Female participants randomized to Groups 1 or 2 must be willing to add a double-barrier method, IUD, or abstinence as back-up forms of birth control since ciprofloxacin and doxycycline may decrease the effectiveness of birth control pills, implantable or injectable contraceptives.

You may not qualify if:

• History of allergic reaction or intolerance to quinolone antimicrobials or any medical condition that would contraindicate the use of ciprofloxacin, including and not limited to vascular disorders, tendon disorders, certain genetic connective tissue disorders (e.g., Marfan and Ehlers-Danlos syndrome), prolongation of QT interval, seizures, peripheral neuropathy, increased risk of C. difficile infection.
• History of allergic reaction or intolerance to tetracycline antibiotics or any medical condition that would contraindicate the use of doxycycline including an increased risk of C. difficile infection, increases in BUN or an increased sensitivity to direct sunlight or ultraviolet radiation resulting in erythema.
• Has a need for any of the prohibited medications or requires the medications/foods within the prohibited times.
• Have a tattoo/scar/birthmark or any other skin condition affecting the deltoid area that may interfere with injection site assessments.
• History of anthrax disease, suspected exposure to anthrax, or previous vaccination with any anthrax vaccine.
• Have previously served in the military any time after 1990 or plan to enlist in the military any time from Screening through the final telephone contact.
• Previous anaphylactic reaction, severe systemic response, or serious hypersensitivity to a prior immunization or a known allergy to synthetic ODNs, aluminum, formaldehyde, benzethonium chloride (phemerol).
• Plan to have an elective surgery at any point during the study until after the final safety phone contact.
• Have donated or plan to donate blood within one month prior to enrollment or at any point during the study until after the final safety phone contact.
• Use of any investigational or non-registered product (drug, vaccine or biologic) within 30 days preceding the dose of study vaccine, or planned use during the study until after the final safety phone contact.
• Planned administration of any commercially-available vaccine from one week prior to the first study vaccination through two weeks after the last vaccination.
• Have experienced chronic dosing (defined as more than 14 days) with any immune-modifying drugs within six months of study enrollment. This includes oral, intramuscular, intra-articular, intravenous, or inhalation corticosteroids except in the case of inhaled or intranasal medications for seasonal allergies.
• Receipt of immunoglobulins and/or any blood products within the three months preceding study enrollment or at any point during the study period until after the final safety visit on Day 51.
• Have an active malignancy or history of metastatic or hematologic malignancy.
• Have a history of an autoimmune, inflammatory, vasculitic or rheumaticor rheumatic disease including but not limited to systemic lupus erythematosus, Guillain-Barré syndrome, myasthenia gravis, polymyalgia rheumatica, diabetes mellitus type I, rheumatoid arthritis or scleroderma.

Sponsors & Collaborators

• Emergent BioSolutions: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (4)

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

The Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

Meridian Clinical Research, LLC

Omaha, Nebraska, 68134, United States

Location

New Orleans Center for Clinical Research / Volunteer Research Group

Knoxville, Tennessee, 37920, United States

Location

Related Publications (1)

• Drobic B, Akintunde G, Kim J, Mirceta M, Beach M, Komlenovic V. Effect of Co-administration of the anthrax vaccine adsorbed, adjuvanted with ciprofloxacin or doxycycline on antibiotic pharmacokinetics and the vaccine immunogenicity: A phase 2 drug-vaccine interaction study. Vaccine. 2026 Feb 15;73:128135. doi: 10.1016/j.vaccine.2025.128135. Epub 2025 Dec 24.

  PMID: 41447782 DERIVED

MeSH Terms

Conditions

Anthrax

Interventions

Ciprofloxacin; Tablets; Doxycycline

Condition Hierarchy (Ancestors)

Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Limitations and Caveats

No Limitations and Caveats in the study

Results Point of Contact

• Title: Clinical Development Representative
• Organization: Emergent Biosolutions

ctgov@ebsi.com

+1 (204) 275-4196

Study Officials

• Bojan Drobic

  Emergent BioSolutions

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: August 26, 2019
• Study Start: August 12, 2019
• Primary Completion: March 5, 2020
• Study Completion: March 19, 2020
• Last Updated: September 8, 2025
• Results First Posted: June 30, 2021

Record last verified: 2025-08

Locations

US (4)