Clinical trial: DCVax Plus Poly ICLC in Healthy Volunteers (NCT01127464)

Eligibility criteria:
Inclusion Criteria:

          1. Healthy adult males and females, as assessed by a medical history, physical exam, and
             laboratory tests

          2. Age of at least 18 years of age on the day of screening and no greater than 60 years
             at time of vaccination

          3. Willing to comply with the requirements of the protocol and available for follow-up
             for the planned duration of the study (screening plus 15 months)

          4. 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)

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

          6. 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;

          7. If sexually active female, using an effective method of contraception (combined oral
             contraceptive pill; injectable contraceptive; diaphragm; Intra Uterine Device (IUD);
             condoms; anatomical sterility in self or partner) throughout the study period. All
             female volunteers must be willing to undergo urine pregnancy tests at time points as
             indicated

          8. If sexually active male, willing to use an effective method of contraception (such as
             condoms, anatomical sterility) from screening until 4 weeks after last vaccination
             (same as above) and will be advised not to get his partner(s) pregnant

        Exclusion Criteria:

          1. Confirmed HIV-1 or HIV-2 infection

          2. 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

          3. 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

          4. 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, CO2, CBC, urinalysis as determined by the
             Principal Investigator or his designee as well as creatinine if the estimated
             glomerular filtration rate is > 60 mL/min/1.73 m2

          5. 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

          6. 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), Chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent
             cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, hepatitis B
             (surface antigen, HbsAg) or hepatitis C (HCV antibodies)

          7. If female, pregnant, planning a pregnancy during the trial period, or lactating

          8. Receipt of a live attenuated vaccine within 30 days or other vaccine within 14 days
             prior to DEC-205 vaccination

          9. Receipt of another experimental HIV vaccine at any time

         10. Receipt of blood transfusion or blood products 6 months prior to vaccination

         11. Participation in another clinical study of an investigational product currently or
             within past 12 weeks, or expected participation during this study

         12. History of severe local or systemic reactogenicity to vaccination or history of severe
             allergic reactions

         13. Major psychiatric illness

         14. 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 60 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? 1