Clinical trial: Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA) HIV Vaccine in HIV Uninfected Adults (NCT00252148)

Eligibility criteria:
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"
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years

Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? Entailment