Phase I Trial of Smallpox Vaccine

Exclusion Criteria

• •Volunteers are excluded from study participation if one or more of the following criteria applies:
• •Prior vaccination with any vaccinia product.
• •Diseases or conditions that cause immunodeficiency (examples are HIV AIDS, leukemia, lymphoma, generalized malignancy, agammaglobulinemia, history of transplantation, or therapy with alkylating agents, antimetabolites, radiation, or oral or parenteral corticosteroids).
• •In close physical contact (household or at work) with an individual who has the diseases or conditions that cause immunodeficiency.
• •History of eczema, even if the condition is mild or not presently active.
• •In close physical contact (household or at work) with an individual who has eczema even if mild or not presently active.
• •Acute or chronic skin conditions such as atopic dermatitis, burns, impetigo, or varicella zoster (shingles).
• •Household member who is pregnant.
• •Women who are breast-feeding.
• •Household member less than 1 year old or work with children less than 1 year old.
• •Serious, life-threatening allergies to antibiotics polymixin B, streptomycin, tetracycline, neomycin, or cidofovir.
• •Allergy to eggs or blood products (including immunoglobulin products) or hypersensitivity to probenicid or sulfa-containing medications.
• •Receipt of live attenuated viruses within 30 days prior to enrollment.
• •Receipt of subunit or killed vaccines within 14 days prior to enrollment.
• •Use of investigational research agents within 30 days prior to enrollment.
• •Receipt of blood products within 120 days prior to HIV screening.
• •Receipt of immunoglobulin within 60 days prior to HIV screening.
• •History of serious adverse reactions to vaccines such as anaphylaxis or related symptoms such as hives, respiratory difficulty, angioedema and abdominal pain.
• •History of type I or type II diabetes mellitus except gestational diabetes or diabetes controlled with diet alone.
• •Participant currently taking anti-TB prophylaxis or therapy.
• •History of seizure disorder other than: 1) febrile seizures under the age of two, or 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) a singular seizure more than 3 years ago.
• •Bleeding disorder diagnosed by a physician (e.g., factor deficiency, coagulopathy, or platelet disorder that requires special precautions).
• •Splenectomy
• •Hypertension that is not well controlled by medication or is more than 150/100 at enrollment.
• •Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well-controlled on medication within the past two years; disorder requiring lithium; suicidal ideation within the five years prior to enrollment.
• •Any medical, psychiatric, social condition, or occupational or other responsibility that, in the judgment of the investigator, would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent.
• •History of military service 1989 or earlier.
• •History of cardiomyopathy, myocardial infarction, angina, congestive heart failure, coronary artery disease, stroke, transient ischemic attack or history of 3 or more risk factors for coronary heart disease from the following list:
• •current cigarette smoking;
• •high blood pressure diagnosed by a doctor;
• •high blood cholesterol diagnosed by a doctor;
• •diabetes diagnosed by a doctor;
• •a first degree relative (father, mother, brother, sister) who had coronary artery disease before the age of 50.