ClinicalTrials.gg
CompletedNCT04067011Updated Sep 8, 2025Results posted

Velocity 2: An Anthrax Vaccine and Antibiotics Clinical Study

A Phase 2 interventional study of Ciprofloxacin 500Mg Tablet and Doxycycline 100Mg Tablet in Anthrax, sponsored by Emergent BioSolutions. Completed at 4 sites in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-08.

Sponsored by Emergent BioSolutions · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anthrax

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Keywords

  • Antibiotics
  • Pharmacokinetics
  • Vaccine
  • Ciprofloxacin
  • Doxycycline
  • CPG 7909
  • Bacillus anthracis
  • Anthrax Vaccine Adsorbed
  • Post-exposure Prophylaxis
  • Adjuvant
03

In context

Anthrax

75 studies on the registry are indexed under Anthrax; 12 are open to participants now.

This study's enrollment of 210 is above the median of 100 across 57 interventional studies indexed under Anthrax.

Browse Anthrax studies →

Lead sponsor

Emergent BioSolutions is the lead sponsor of 47 studies on the registry; 7 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 7 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Written obtained from the participant (dated, signed, and captured in the medical chart at the site).
  2. A male or female, aged 18 to 45 years of age, inclusive, at the time of informed consent.
  3. Healthy condition as established by medical history and clinical examination before entering into the study.
  4. (BMI) less than or equal to 35.0 kg/m\^2 at the Screening visit.
  5. Have adequate venous access for phlebotomies.
  6. For a woman of (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 product (IP). Every female participant is considered to be a WOCBP unless she is surgically sterile (hysterectomy, bilateral salpingectomy or bilateral oophorectomy) OR (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 since ciprofloxacin and doxycycline may decrease the effectiveness of birth control pills, implantable or injectable contraceptives.

Exclusion criteria

Exclusion Criteria:

  1. A Screening clinical laboratory test result greater than the central laboratory's (ULN) for (AST), alanine aminotransferase (ALT), random glucose, total , blood urea nitrogen (BUN), or creatinine. Other serum chemistry parameters that are not within the reference range will not be considered exclusionary unless deemed by the principal investigator.
  2. 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 , seizures, peripheral neuropathy, increased risk of C. difficile infection.
  3. 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.
  4. Has a need for any of the prohibited medications or requires the medications/foods within the prohibited times.
  5. Have a tattoo/scar/birthmark or any other skin condition affecting the deltoid area that may interfere with injection site assessments.
  6. History of anthrax disease, suspected exposure to anthrax, or previous vaccination with any anthrax vaccine.
  7. 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.
  8. Previous anaphylactic reaction, severe systemic response, or serious to a prior immunization or a known allergy to synthetic ODNs, aluminum, formaldehyde, benzethonium chloride (phemerol).
  9. Plan to have an elective surgery at any point during the study until after the final safety phone contact.
  10. 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.
  11. Use of any 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.
  12. Planned administration of any commercially-available vaccine from one week prior to the first study vaccination through two weeks after the last vaccination.
  13. 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 except in the case of inhaled or intranasal medications for seasonal allergies.
  14. 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.
  15. An abnormal (ECG) at screening interpreted as 'Abnormal, Significant'. Inclusion of participants with 'Abnormal, Insignificant' ECGs will be based on the principal investigator's discretion.
  16. Have an active or history of or hematologic malignancy.
  17. Have a history of an , 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.
  18. A positive laboratory evidence of , , or (HIV) HIV-1 or HIV-2 infection.
  19. Positive result on urine drug screen, any evidence of ongoing drug abuse or dependence (including alcohol), or recent history (over the past five years) of treatment for alcohol or drug abuse.
  20. Has an acute disease at the time of enrollment.
  21. Any medical condition that, in the opinion of the investigator, could adversely impact the participant's involvement or the conduct of the study.
  22. Have a significant chronic condition, e.g., serious cardiovascular, pulmonary, hepatic, type II diabetes mellitus or renal disease that, in the opinion of the investigator, would render treatment unsafe or would interfere with trial evaluations or completion of the study.
  23. An opinion of the investigator that it would be unwise to allow the participant to be randomized into the study.
  24. Member or immediate family member of an investigator site team.
Terms in these criteria, in plain language(20)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
210 participants (actual)

Study arms

  • Experimental
    Group 1:Ciprofloxacin + AV7909

    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

  • Experimental
    Group 2: Doxycycline +AV7909

    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

  • Experimental
    Group 3: AV7909

    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 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.

  • BiologicalAV7909

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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)

  2. 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.

    Time frame: 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).

    Immunogenicity response as assessed by geometric mean of TNA NF50 values at Day 37 (two weeks after second dose of AV7909 vaccination).

    Time frame: Day 37 ± 1 day

07

Results

Posted Jun 30, 2021
Limitations and caveats
No Limitations and Caveats in the study

Participant flow

Participant flow — Overall Study
MilestoneGroup 1:Ciprofloxacin + AV7909Group 2: Doxycycline +AV7909Group 3: AV7909
Started707169
Completed515861
Not completed19138
Withdrew: Not treated875
Withdrew: Adverse event210
Withdrew: Withdrawal by subject621
Withdrew: Lost to follow-up001
Withdrew: Physician decision110
Withdrew: Other reasons201
Withdrew: Missing020

Outcome measures

PrimaryRatio 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.

Time frame:
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)
Reported as:
Geometric mean · Ratio
Ratio of Ciprofloxacin Area Under the Curve From 0 to 12 Hours (AUC0-12h) and Maximum Concentration (Cmax) on Days 8 and 35
RatioCiprofloxacin + AV7909
Ratios of AUC0-12h (Post-vac./Pre-vac)0.9764 (0.8895 to 1.0718)
Ratios of Cmax (Post-vac./Pre-vac)0.9706 (0.8693 to 1.0838)
Statistical analysis
  • Ciprofloxacin + AV7909 · Ratio of auc: 0.9764 · 90% CI 0.8895 to 1.0718
  • Ciprofloxacin + AV7909 · Ratio of cmax: 0.9706 · 90% CI 0.8693 to 1.0838
PrimaryRatio 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.

Time frame:
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)
Reported as:
Geometric mean · Ratio
Ratio of Doxycycline Area Under the Curve From 0 to 12 Hours (AUC0-12h) and Maximum Concentration (Cmax) on Days 8 and 38
RatioDoxycycline + AV7909
Ratios of AUC0-12h (Post-vac./Pre-vac)0.9173 (0.8187 to 1.0278)
Ratios of Cmax (Post-vac./Pre-vac)0.8974 (0.7841 to 1.0271)
Statistical analysis
  • Doxycycline + AV7909 · Ratio of auc: 0.9173 · 90% CI 0.8187 to 1.0278
  • Doxycycline + AV7909 · Ratio of cmax: 0.8974 · 90% CI 0.7841 to 1.0271
SecondaryGeometric Mean TNA 50% Neutralizing Factor (NF50) Values Two Weeks After the Second AV7909 Vaccination (Day 37 ± 1 Day).

Immunogenicity response as assessed by geometric mean of TNA NF50 values at Day 37 (two weeks after second dose of AV7909 vaccination).

Time frame:
Day 37 ± 1 day
Reported as:
Geometric mean · TNA NF50 titer
Geometric Mean TNA 50% Neutralizing Factor (NF50) Values Two Weeks After the Second AV7909 Vaccination (Day 37 ± 1 Day).
TNA NF50 titerGroup 1:Ciprofloxacin + AV7909Group 2: Doxycycline +AV7909Group 3: AV7909
Geometric Mean TNA 50% Neutralizing Factor (NF50) Values Two Weeks After the Second AV7909 Vaccination (Day 37 ± 1 Day).1.8 (1.3 to 2.4)1.8 (1.4 to 2.3)1.6 (1.3 to 2.0)
Statistical analysis
  • Group 1:Ciprofloxacin + AV7909 vs Group 3: AV7909 · Ratio of gmt (group 1/group 3): 1.13 · 95% CI 0.78 to 1.64
  • Group 2: Doxycycline +AV7909 vs Group 3: AV7909 · Ratio of gmt (group 2/group 3): 1.14 · 95% CI 0.81 to 1.6

Adverse events

Collected over Incidence of adverse events (AEs) from the first dose of any study treatment (either antibiotic and/or AV7909 vaccine) through the Final Study Visit (Day 51 ± 1 day). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1: Ciprofloxacin + AV79090/62 (0%)1/62 (1.6%)17/62 (27.4%)
Group 2: Doxycycline +AV79090/64 (0%)0/64 (0%)17/64 (26.6%)
Group 3: AV79090/64 (0%)1/64 (1.6%)16/64 (25%)
Most frequent serious events
Most frequent serious events
EventGroup 1: Ciprofloxacin + AV7909Group 2: Doxycycline +AV7909Group 3: AV7909
Gastroenteritis viralInfections and infestations1/620/640/64
Uterine prolapseReproductive system and breast disorders0/620/641/64
Most frequent other events
Most frequent other events
EventGroup 1: Ciprofloxacin + AV7909Group 2: Doxycycline +AV7909Group 3: AV7909
Injection site painGeneral disorders6/625/648/64
Injection site indurationGeneral disorders2/627/645/64
Vaccination complicationInjury, poisoning and procedural complications3/624/647/64
Musculoskeletal procedural complicationInjury, poisoning and procedural complications4/624/644/64
NauseaGastrointestinal disorders2/624/641/64
VomitingGastrointestinal disorders1/624/641/64
Procedural headacheInjury, poisoning and procedural complications2/624/642/64
Injection site movement impairmentGeneral disorders3/622/644/64

Baseline characteristics

Intent to treat population: all subjects who were randomized.

Age, Customized
Age, Customized(Participants)Group 1:Ciprofloxacin + AV7909Group 2: Doxycycline +AV7909Group 3: AV7909Total
18 - 30 years29303190
31 - 45 years414138120
Sex: Female, Male
Sex: Female, Male(Participants)Group 1:Ciprofloxacin + AV7909Group 2: Doxycycline +AV7909Group 3: AV7909Total
Female444743134
Male26242676
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Group 1:Ciprofloxacin + AV7909Group 2: Doxycycline +AV7909Group 3: AV7909Total
American Indian or Alaska Native2013
Asian1102
Native Hawaiian or Other Pacific Islander0011
Black or African American20261763
White464348137
More than one race1113
Unknown or Not Reported0011
Region of Enrollment
Region of Enrollment(participants)Group 1:Ciprofloxacin + AV7909Group 2: Doxycycline +AV7909Group 3: AV7909Total
United States707169210
Height
Height(cm)Group 1:Ciprofloxacin + AV7909Group 2: Doxycycline +AV7909Group 3: AV7909Total
Mean170.1 ± 9.8169.1 ± 8.5169.7 ± 10.7169.6 ± 9.7
Weight
Weight(kg)Group 1:Ciprofloxacin + AV7909Group 2: Doxycycline +AV7909Group 3: AV7909Total
Mean78.7 ± 16.779.4 ± 12.675.0 ± 16.077.7 ± 15.2
BMI
BMI(kg/m^2)Group 1:Ciprofloxacin + AV7909Group 2: Doxycycline +AV7909Group 3: AV7909Total
Mean27.1 ± 4.927.7 ± 3.725.9 ± 4.626.9 ± 4.4
08

Study locations

4 sites
  • Avail Clinical Research, LLC
    DeLand, Florida 32720, United States
  • The Center for Pharmaceutical Research
    Kansas City, Missouri 64114, United States
  • Meridian Clinical Research, LLC
    Omaha, Nebraska 68134, United States
  • New Orleans Center for Clinical Research / Volunteer Research Group
    Knoxville, Tennessee 37920, United States
09

References and documents

Publications

  • 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. PubMed 41447782 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04067011
Collaborators
Biomedical Advanced Research and Development Authority
Responsible party
Sponsor
First posted
Aug 26, 2019
Start date
Aug 12, 2019
Primary completion
Mar 5, 2020
Completion
Mar 19, 2020
Results posted
Jun 30, 2021
Last update
Sep 8, 2025

Study contacts

Bojan Drobic
study director · Emergent BioSolutions

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Ciprofloxacin · Doxycycline · AV7909

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