ACAM 3000 MVA at Harvard Medical School

Exclusion Criteria

• •Prior vaccination with a vaccinia product. Determined by clinical evidence of scarification or self-reported history of vaccinia vaccination (such as in the United States military before 1991 or after 2003).
• •Immunosuppressive medications within 168 days prior to initial study vaccine administration, e.g., oral/parenteral corticosteroids, and/or cytotoxic medications. Not excluded: A participant using any of the following is not excluded: corticosteroid nasal spray for allergic rhinitis; or topical corticosteroids as prescribed by a physician for an acute, uncomplicated dermatitis; or over the counter medications (including topical corticosteroids for an acute, uncomplicated dermatitis); use of rapidly tapered steroids for an acute isolated condition, which does not include asthma within 28 days prior to vaccine administration.
• •Currently using corticosteroid eye drops.
• •Receipt of blood products within 120 days prior to initial study vaccine administration.
• •Receipt of immunoglobulin within 60 days prior to initial study vaccine administration.
• •Receipt of live attenuated vaccines within 30 days prior to initial study vaccine administration.
• •Receipt of investigational research agents within 30 days prior to initial study vaccine administration.
• •Receipt of medically indicated subunit or killed vaccines, e.g., influenza, pneumococcal, or allergy treatment with antigen injections within 14 days prior to initial study vaccine administration.
• •Participant has a history of any of the following:
• •Acute febrile illness on the day of vaccination.
• •Eczema or atopic dermatitis (past or present).
• •Chronic exfoliative skin condition.
• •Acute skin disorders of large magnitude (greater than 2x2 centimeters), e.g., burns or lacerations.
• •History or presence of skin cancer at vaccination site.
• •Heart disease including history of a myocardial infarction (MI), angina, congestive heart failure (CHF), or pericardial pathology.
• •Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's risk assessment tool (http://hin.nhlbi.nih.gov/atpiii/calculator.asp).
• •NOTE: This criterion applies only to subjects 20 years of age and older AND only if at least one of the following applies:
• •a) have smoked a cigarette in the past month, and/or b) have hypertension (defined as systolic blood pressure greater than 140 mm Hg) or are on antihypertensive medication, and/or c) have a family history of coronary heart disease in male first-degree relative (father or brother) less than 55 years of age or a female first-degree relative (mother or sister) less than 65 years of age.
• •Household contacts/sexual contacts with, or frequent and/or prolonged exposure to any of the following:
• •a) Children less than 12 months of age b) Pregnant women or women who are breast feeding c) Individuals with a history of eczema or atopic dermatitis d) Individuals with chronic exfoliative skin disorders or skin disorders of large magnitude (greater than 2x2 centimeters) e) Individuals with an immunosuppressive disorder such as HIV infection, organ transplantation, or a condition requiring prolonged corticosteroid therapy
• •Electrocardiogram (ECG) with clinically significant findings, or features that would interfere with the assessment of myo/pericarditis as determined by the consulting cardiologist, including any of the following: (1) Conduction disturbance (complete left or incomplete right bundle branch block or nonspecific intraventricular conduction disturbance with waves of ventricular activity of the heart traced on an ECG (QRS) greater than 120 millisecond (ms), atrioventricular (AV) block of any degree, or QTc prolongation (greater than 440 ms); (2) Repolarization (ST segment or T wave) abnormality; (3) Significant atrial or ventricular arrhythmia; (4) Frequent atrial or ventricular ectopy (e.g. frequent premature atrial contractions, 2 premature ventricular contractions in a row); (5) ST elevation consistent with ischemia; (6) Evidence of past or evolving myocardial infarction.
• •Known or suspected allergy to any component of the vaccine or diluent.
• •Allergy to eggs or blood products \[including immunoglobulin (IgG) or vaccinia immunoglobulin\].
• •Serious adverse reactions to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. Not excluded: A participant who had an adverse reaction to pertussis vaccine as a child is not excluded.
• •Autoimmune disease.
• •Immunodeficiency.
• •Asthma that is unstable, e.g., use of oral or intravenous corticosteroids, hospitalization or intubation during the past 2 years a) Inhaled steroids are not permissible
• •Diabetes mellitus type I or type II including cases controlled with diet alone. Not excluded: A participant with past gestational diabetes is not excluded.
• •Bleeding disorder diagnosed by a doctor, e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions. Not excluded: A participant who states he/she has easy bruising or bleeding, but does not carry a formal diagnosis and has had intramuscular (IM) injections and blood draws without any adverse experience, is not excluded.
• •Seizure disorder not excluded: A participant with a remote history (over 3 years ago) of seizure who has not required medications for over 3 years is not excluded if (a) the seizures were febrile seizures under the age of 2, or (b) secondary to alcohol withdrawal, or (c) if the seizure only occurred once.
• •Asplenia. Any condition resulting in the absence or removal of the spleen.
• •Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with one or more of the following:
• •a) Psychoses within the past 5 years. b) Suicidal ideation occurring within 2 years prior to enrollment. Not excluded: A participant with a remote history (greater than 3 years) of a suicide attempt or suicide gesture is not excluded if the investigator finds the participant (a) to be of sound mental health; and (b) the suicide attempt was a well-defined, isolated event; and (c) the cause or inciting factor(s) no longer has relevance to the individual. A participant currently in therapy, due to a suicide attempt or gesture, or suicidal ideation, may be enrolled only when the participant's current therapist or health care provider provides documentation that the participant currently is not suicidal.
• •Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence or a participant's ability to give informed consent.
• •Female participants: Participant is pregnant and/or breast-feeding.
• •A history of the following:
• •1. Excessive scarring
• •2. Known or suspected allergy to any component of the vaccine or diluent including polymyxin B sulfate, dihydrostreptomycin sulfate, chlorotetracycline hydrochloride, neomycin, and phenol.
• •3. Known allergy to cidofovir or probenecid -Abnormal renal function:
• •a) A calculated creatinine clearance less than 80 mL/min based on the following formulas: i) Males: \[(140 - age in years) X weight in kilograms (kg)\]/(72 X serum creatinine) ii) Females: 0.85 X \[(140 - age in years) X weight in kg\]/(72 X serum creatinine)