Safety, Tolerability and Immune Response of IMVAMUNE (MVA-BN)Smallpox Vaccine in HIV Infected Patients

Exclusion Criteria

• •Pregnant or breast-feeding women.
• •Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
• •History of any serious medical condition (other than HIV infection).
• •History of or active autoimmune disease.
• •Known or suspected impairment of immunologic function (other than HIV infection).
• •History of malignancy.
• •History or clinical manifestation of clinically significant and severe haematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
• •Clinically significant mental disorder not adequately controlled by medical treatment.
• •Any condition which might interfere with study objectives.
• •History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor.
• •History of an immediate family member with onset of ischemic heart disease before age 50.
• •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.
• •History of chronic alcohol abuse and/or intravenous drug abuse.
• •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• •Known previous allergic reaction to immunoglobulins.
• •Known allergies to cidofovir or probenecid.
• •History of anaphylaxis or severe allergic reaction.
• •Acute disease (illness with or without a fever) at the time of enrollment.
• •Temperature \>100.4°F at the time of enrollment.
• •Subjects undergoing treatment for tuberculosis infection or disease.
• •Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior or after study vaccination.
• •Having received any vaccinations or planned vaccinations with a killed vaccine within 14 days prior or after study vaccination.
• •Chronic administration of immuno-suppressant or immune-modifying drugs.
• •Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy.
• •Administration or planned administration of immunoglobulins and/or any blood products.
• •Use of any investigational or non-registered drug or vaccine.