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

- 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.