Anthrax AV7909 Liquid vs Lyophilized

Inclusion Criteria

• •1. Provide written informed consent prior to initiation of any study procedures.
• •2. Understand and comply with planned study procedures, including completion of the electronic memory aid, and be available for all study visits.
• •3. Agree to the collection of venous blood, per protocol.
• •4. Have adequate venous access for phlebotomies.
• •5. Be a male or non-pregnant female, 18 to 45 years of age, inclusive, at the time of enrollment.
• •6. Be in good health.\*
• •\* As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical diagnoses or conditions, which would affect the assessment of the safety of participants or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days, should be stable (not worsening) for the last 60 days (no hospitalizations, emergency room or urgent care for condition, or invasive medical procedure and no adverse symptoms that need medical intervention such as medication change indicative of worsening/supplemental oxygen). This includes no change in chronic prescription medication, dose or frequency, indicative of worsening disease, in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, will not be considered a deviation of this inclusion criterion. Participants may be on chronic or as needed (prn) medications if, in the opinion of the site PI or appropriate sub-investigator, they pose no additional risk to participant safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening or treatment of continued symptoms of medical diagnosis or condition. Herbals, vitamins, and supplements are permitted.
• •7. Have an oral temperature less than 100.0 degrees Fahrenheit.
• •8. Have a pulse 51 to 100 beats per minute, inclusive.
• •9. Have a systolic blood pressure 85 to 140 mmHg, inclusive.
• •10. Have a diastolic blood pressure 55 to 90 mmHg, inclusive.
• •11. Have a calculated body mass index (BMI) less than or equal to 35.0 kg/m2 at screening.
• •12. Screening laboratories are within acceptable parameters:
• •* BUN \<23 mg/dL
• •* Serum creatinine (female) \<1.3 mg/dL
• •* Serum creatinine (male) \< 1.4 mg/dL
• •* Alkaline phosphatase (female) \<147 U/L
• •* Alkaline phosphatase (male) \<192 U/L
• •* ALT (aka SGPT) \<68 U/L
• •* Total bilirubin \< 1.3 mg/dL
• •* Hemoglobin (female) \>10.9 g/dL
• •* Hemoglobin (male) \> 12.4 g/dL
• •* White blood cell count 3000-12,000 cells/mm3
• •* Absolute eosinophil count \<1201 cells/mm3
• •* Absolute neutrophil count \>1200 cells/mm3
• •* Platelets \>126,000 cells/mm3
• •* Hemoglobin A1C \<6.5%
• •* Urine for Drugs of Abuse (amphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, oxycodone/oxymorphone, phencyclidine (PCP), and propoxyphene). All negative
• •* HBsAg Non-reactive
• •* HCV antibodies Negative
• •* HIV 4th generation test Negative
• •13. Have no clinically significant findings on 12-lead electrocardiogram.\*
• •\* Clinical significance will be determined by a cardiologist. Examples of findings that will lead to exclusion are significant left ventricular hypertrophy, right or left bundle branch block, advanced A-V heart block, non-sinus rhythm (excluding isolated premature atrial contractions), pathologic Q wave abnormalities, significant ST-T wave changes, prolonged QTc interval.
• •14. Heterosexually active females of childbearing potential\* must use an acceptable contraception method\*\* from at least 30 days before the first until 60 days after the second study vaccination.
• •* Not sterilized via bilateral oophorectomy, salpingectomy, hysterectomy, or successful Essure(R) placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or \<1 year has passed since the last menses, if menopausal.
• •* Includes full abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more or shown to be azoospermic prior to the participant receiving the study vaccination, barrier methods such as condoms or diaphragms/cervical cap, intrauterine devices, NuvaRing(R), tubal ligation, and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill").
• •15. Females of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to each study vaccination.
• •16. For a female with potential to become pregnant, she understands that in the event of pregnancy during the study she will be asked to allow us to follow her during pregnancy through outcome.
• •17. Must agree to have blood collected, stored, and potentially used for auto-antibody studies (if a suspected Potentially Immune-Mediated Medical Conditions (PIMMC) occurs in this participant).