Safety and Immunogenicity of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in HIV Infected Patients

A Multicenter, Open-label, Controlled Phase II Study to Evaluate Safety and Immunogenicity of MVA-BN® (IMVAMUNE) Smallpox Vaccine in 18-55 Year Old Naive and Previously Vaccinated HIV Infected Subjects With CD4 Counts >200 - 750/µl.

The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in HIV infected populations. Subjects will receive two vaccinations

• Genders eligible for Study: Both
• Age: between 18 and 55 years
• Healthy volunteers are accepted

Inclusion Criteria:

• Subjects tested positive for HIV-1 infection (HIV-infected subjects).
• Subjects that are tested negative for HIV (Healthy subjects).
• Either on stable antiretroviral therapy or not on antiretroviral therapy.
• CD4 cells > = 200 - 750/µl.
• Subjects must be in good general health except for HIV infection.
• Women must not be pregnant and use an acceptable method of contraception.

Exclusion Criteria:

• Impairment of immunologic function (other than HIV infection).
• History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure.
• Uncontrolled serious infection.
• History of or active autoimmune disease.
• History or clinical manifestation of clinically significant and severe hematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
• History of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before the age of 50 years.
• High risk of developing a myocardial infarction or coronary death.
• History of intravenous drug abuse (within the last 12 months).
• Known allergy to egg or aminoglycoside (gentamicin).
• History of anaphylaxis or severe allergic reaction.
• Subjects undergoing treatment for tuberculosis infection or disease.
• Chronic administration of systemic immuno-suppressants.