CDC Anthrax Vaccine Clinical Trial

Inclusion Criteria: Read and signed the Informed Consent Document Female or male, 18 to 61 years old (up to 62nd birthday) Females must agree to exercise adequate birth control from the time of the screening procedures to one month after the last vaccination Willingness and ability to return for all follow-up visits and blood collections for the duration of the study Ability to understand and comply with planned study procedures Agree to complete the Participant Diary (Appendix G) and to report concomitant medications and AEs during the study period Have two intact upper arms with sufficient subcutaneous and intramuscular tissue in the deltoid regions for vaccine administration. Potential participants with a history of the following conditions remain eligible for study enrollment: gestational diabetes; treated, controlled, uncomplicated hypertension; treated hypo- or hyperthyroidism; cured nonmetastatic cancer; disease-free for 5 years (excluding hematologic malignancies); localized skin cancer, resected (including squamous cell and basal cell carcinomas, participants with a history of melanoma must be disease-free for 5 years); exercise-induced bronchospasm; mild asthma: use of inhalers only for control of symptoms is acceptable (Persons who have required hospitalization for asthma within the previous 2 years or those who require chronic or frequent oral/parenteral steroids will not be eligible; use of low to medium doses of inhaled steroids; history of coronary artery disease, asymptomatic (NYHA Function Class I), on a stable medical regimen. Persons meeting these criteria must be at least 2 years post-myocardial infarction, cardiac bypass surgery, and/or percutaneous coronary intervention (e.g., angioplasty, stent placement, etc) in order to qualify. Persons with a history of cardiac disease must be under the care of a physician. Exclusion Criteria: Prior history of anthrax or immunization against anthrax Known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, or latex Pregnancy or plans to become pregnant for the duration of the study and/or not agreeing to exercise adequate birth control from the time of the screening procedures to one month after the last vaccination Received experimental products within 30 days prior to study entry Plans to receive experimental products within 60 days after study entry Received a live vaccine outside this trial within 30 days prior to study entry Received an inactivated vaccine outside this trial within 14 days prior to study entry Plans to receive a live vaccine outside this trial within 60 days after study entry Plans to receive an inactivated vaccine outside this trial within 42 days after study entry Received immunosuppressive therapy within 30 days prior to study entry Plans to receive immunosuppressive therapy within 60 days after study entry Use of cytotoxic therapy in the previous 5 years Plans to receive cytotoxic therapy within 60 days after study entry Receipt of parenteral immunoglobulin or blood products within three months of study Plans to receive parenteral immunoglobulin or blood products within 60 days after study entry Active malignancy or history of metastatic or hematologic malignancy Any current diabetes Cardiovascular disease with a significant likelihood of progression over 5 years, including any person with a history of cardiomyopathy or congestive heart failure Moderate to severe asthma, chronic obstructive pulmonary disease, other significant pulmonary disease Persons who are using high doses of inhaled steroids Clinically recognized hepatic or renal insufficiency Inflammatory, vasculitic, or rheumatic disease including systemic lupus erythematosis, polymyalgia rheumatica and rheumatoid arthritis, scleroderma Known HIV, hepatitis B or hepatitis C infection Other conditions known to produce or be associated with immune suppression Neuropathy or other evolving neurologic condition Unstable and/or moderate to severe mental illness Ongoing drug abuse/dependence (including alcohol) Seizure disorder In addition to the conditions listed above, moderate or severe illness and/or oral temperature higher than 100.4˚F within 3 days of injection or chronic condition that, in the opinion of the investigator, would render injection unsafe or would interfere with evaluations would be considered a temporary exclusion criterion.