Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA) HIV Vaccine in HIV Uninfected Adults

Inclusion Criteria:

• Healthy adult males and females, as assessed by a medical history, physical exam, and laboratory tests;
• Age of at least 18 years of age on the day of screening and no greater than 40 years on the day of first vaccination;
• Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study (screening plus 18 months);
• In the opinion of the principal investigator or designee has understood the information provided. Written informed consent needs to be given before any study-related procedures are performed;
• Willing to undergo HIV Testing and counseling, and receive HIV test results;
• If sexually active female, using an effective method of contraception from screening until at least 4 months after last vaccination. All female volunteers must be willing to undergo urine pregnancy tests.
• If sexually active male, willing to use an effective method of contraception from screening until 4 months after the last vaccination and will be advised not to get his partner pregnant.

Exclusion Criteria:

• Confirmed HIV-1 or HIV-2 infection;
• Reported high-risk behavior for HIV infection defined as:

Within 6 months before vaccination, the volunteer has:

• Had unprotected vaginal or anal sex with a known HIV infected person or with a casual partner.
• Engaged in sex work for money or drugs
• Used injection drugs (illicit), or
• Acquired an STD;
• Any clinically significant abnormality on history or examination including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive, antiviral, anticancer, or other medications considered significant by the trial physician within the last 6 months;
• Any clinically significant acute or chronic medical condition requiring care of a physician (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that in the opinion of the investigator would preclude participation;
• Any of the following abnormal laboratory parameters listed below:
• Hemoglobin: <9.0 g/dL
• Absolute Neutrophil Count (ANL): ≤ 999/mm3
• Absolute Lymphocyte Count (ALC): ≤ 500/mm3
• Platelets: ≤ 90,000 ≥ 550,000/mm3
• Creatinine: > 1.4 x ULN
• AST: >3.0 x ULN
• ALT: >3.0 x ULN
• Urine dipstick: blood = 2+ or more (except in menstruating females); protein = 2+or more
• Cardiac troponin I: > ULN;
• Confirmed diagnosis of hepatitis B (surface antigen, HbsAg); hepatitis C (HCV antibodies) or active syphilis;
• If female, pregnant or planning a pregnancy within 4 months after last vaccination or lactating;
• Receipt of a live attenuated vaccine (other than influenza) within 30 days or other vaccine within 14 days of vaccination;
• Receipt of blood transfusion or blood products 6 months prior to vaccination;
• Participation in another clinical study of an investigational product currently or within past 12 weeks or expected participation during this study;
• Receipt of another experimental HIV vaccine at any time;
• History of severe local or systemic reactogenicity to vaccination or history of severe allergic reactions;
• Major psychiatric illness including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, suicidal attempt or ideation in the previous 3 years;
• In the opinion of the investigator, unlikely to comply with protocol;
• ECG with clinically significant findings or features that would interfere with the assessment of myo/pericarditis including:
• conduction disturbance (atrioventricular or intraventricular condition, left or right bundle branch block, AV block of any degree, or QTc prolongation)
• repolarization (ST segment or T wave) abnormality
• significant atrial or ventricular arrhythmia
• frequent atrial or ventricular ectopy (e.g. frequent premature atrial contractions, 2 premature ventricular contractions in a row)
• ST elevation consistent with ischemia
• evidence of past or evolving myocardial infarction;

History of, or known active cardiac disease including:

• previous myocardial infarction (heart attack)
• angina pectoris
• congestive heart failure
• valvular heart disease including mitral valve prolapse
• cardiomyopathy
• pericarditis
• stroke or transient ischemic attack
• chest pain or shortness of breath with activity (such as walking up stairs)
• other heart conditions under the care of a doctor;

Have 3 or more of the following risk factors:

• high blood pressure diagnosed by a doctor
• high blood cholesterol diagnosed by a doctor
• diabetes or high blood sugar diagnosed by a doctor
• a first degree relative (for example, mother, father, brother, sister) who had a heart condition before the age of 50
• smoke cigarettes now.
• History of allergy to aminoglycosides (e.g. gentamycin)
• History of severe allergy to eggs or egg products e.g., "rash or breathing difficulties"