Velocity 2: An Anthrax Vaccine and Antibiotics Clinical Study (NCT04067011) | Clinical Trial Compass
CompletedPhase 2
Velocity 2: An Anthrax Vaccine and Antibiotics Clinical Study
United States210 participantsStarted 2019-08-12
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. A Screening clinical laboratory test result greater than the central laboratory's upper limit of normal (ULN) for aspartate aminotransferase (AST), alanine aminotransferase (ALT), random glucose, total bilirubin, blood urea nitrogen (BUN), or creatinine. Other serum chemistry parameters that are not within the reference range will not be considered exclusionary unless deemed clinically significant by the principal investigator.
✕. 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.
What they're measuring
1
Ratio of Ciprofloxacin Area Under the Curve From 0 to 12 Hours (AUC0-12h) and Maximum Concentration (Cmax) on Days 8 and 35
Timeframe: 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
Timeframe: 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)
✕. 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).