Clinical trial: A Phase I Study to Evaluate the Safety and Immunogenicity of Heterologous Boost Immunizations With MVA-CMDR (NCT01889719)

Eligibility criteria:
Inclusion Criteria:

          -  Have completed protocol SSC-710 and received either DCVax-001 plus poly ICLC, poly
             ICLC only or sterile saline. If less than 6 volunteers who originally received placebo
             (poly ICLC only or sterile saline) under protocol SSC_710 are willing to participate
             and are found eligible to participate in this proposed study, new volunteers can be
             enrolled as long as they are eligible according to the remaining inclusion and
             exclusion criteria below.

          -  Healthy adult males and females, as assessed by a medical history, physical exam, ECG,
             and laboratory tests;

          -  Age of at least 18 years of age on the day of screening and no greater than 62 years
             at time of vaccination;

          -  Willing to comply with the requirements of the protocol and available for follow-up
             for the planned duration of the study (screening plus 12 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);

          -  Amenable to HIV risk reduction counseling, committed to maintaining behavior
             consistent with low risk of HIV exposure through the last required protocol clinic
             visit;

          -  Assessed by the clinic staff as being at "low risk" for HIV infection on the basis of
             sexual behaviors within the 12 months prior to enrollment defined as follows:

          -  Sexually abstinent OR

          -  Had two or fewer mutually monogamous relationships with partners believed to be
             HIV-uninfected and who did not use illicit drugs (illicit drug use or abuse that
             includes any injection drugs, methamphetamines (crystal meth), heroin, cocaine,
             including crack cocaine or chronic marijuana abuse) OR

          -  Had two or fewer partners believed to be HIV-uninfected and who did not use illicit
             drugs (as defined above) and with whom he/she regularly used condoms for vaginal and
             anal intercourse;

          -  If sexually active female, willing to use one effective method of contraception
             (combined oral contraceptive pill; injectable contraceptive; diaphragm; Intra Uterine
             Device (IUD); condoms; anatomical sterility in self or partner) at least until 3
             months after last immunization. All female volunteers must be willing to undergo urine
             pregnancy tests at time points as indicated in the Schedule of Procedures.

        Exclusion Criteria:

          -  Confirmed HIV-1 or HIV-2 infection

          -  Any clinically significant abnormality on history or examination including history of
             immunodeficiency or autoimmune disease; use of systemic corticosteroids
             immunosuppressive 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, myopericarditis, grand-mal
             epilepsy, rheumatologic illness, malignancy, substance abuse) that in the opinion of
             the investigator would preclude participation

          -  History of clinically significant eczema or chronic urticaria

          -  Any laboratory value outside of reference range, with the exception of any
             non-clinically significant Grade I elevations of liver function tests (AST, ALT,
             direct/total bilirubin), electrolytes (Na, K, Cl, CO2), CBC, urinalysis as determined
             by the Principal Investigator or his designee

          -  Baseline ECG with features that would interfere with interpretation of
             myo/pericarditis including significant repolarization abnormality, bundle branch
             block, and AV block

          -  Within the 12 months prior to enrollment, the volunteer has had excessive daily
             alcohol use or frequent binge drinking or chronic marijuana abuse or any other use of
             illicit drugs

          -  Within the 12 months prior to enrollment, the volunteer has a history of
             newly-acquired syphilis, gonorrhea, non-gonococcal urethritis, herpes simplex virus
             type 2 (HSV2), pelvic inflammatory disease (PID), mucopurulent cervicitis,
             epididymitis, proctitis, lymphogranuloma venereum, chancroid, hepatitis B (surface
             antigen, HbsAg) or hepatitis C (HCV antibodies);

          -  If female, pregnant, planning a pregnancy during the 3-month follow up period after
             last immunization, or lactating

          -  Receipt of a live attenuated vaccine within 30 days or other vaccine within 14 days
             prior to study vaccination

          -  Prior use of medications for HIV PrEP

          -  Receipt of an investigational product (not vaccine-related) within the last 12 months.
             Receipt of a non-HIV experimental vaccine(s) within the last 5 years in a prior
             vaccine trial. Exceptions may be made for vaccines that have subsequently undergone
             licensure by the FDA. For subjects who have received control/placebo in an
             experimental vaccine trial, or who have received an experimental vaccine(s) greater
             than 5 years ago, eligibility for enrollment will be determined by the investigators
             on a case-by-case basis.

          -  History of severe local or systemic reaction to vaccination defined as:

          -  Local: extensive, indurated redness and swelling involving most of the major
             circumference of the arm, not resolving within 72 hours;

          -  Systemic: fever > 39.5°C within 48 hours, anaphylaxis, bronchospasm, laryngeal edema,
             circulatory collapse, convulsions or encephalopathy within 72 hours

          -  History of immediate type hypersensitivity reaction to eggs or egg products

          -  Major psychiatric illness

          -  In the opinion of the investigator, unlikely to comply with protocol
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 62 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? Contradiction