Clinical trial NCT00500747 (phase 1, status: completed)
Conditions: hepatitis c
ICD codes: B18.2, B17.10, B17.11, B19.20, B19.21, B15.0, B15.9
Drugs: placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, hepatitis C virus (HCV) negative.

          -  18-45 year old healthy adults. Insufficient data are available in adults to judge risk
             in children.

          -  In good general health as determined by medical history, physical examination and the
             following screening labs:

          -  Complete Blood Count (CBC): Total WBC (White Blood Cell): 3.5-14 thousand/microliter
             (MCL); Hemoglobin (Hgb): Men: 12.2-18 g/dl and Women: 10.5-17 g/dl.

          -  Creatinine: Men: less than or equal to 1.4 mg/dl; Women: less than or equal to 1.2
             mg/dl.

          -  Glucose: 50 mg/dl to less than or equal to 109 mg/dl.

          -  Alanine Aminotransferase (ALT): Men 2-60 units/litre (U/I): Women: 3-40 U/I.

          -  Aspartate Aminotransferase (AST): Men: 2-50 U/I, Women 2-35 U/I.

          -  Total bilirubin: Men: less than or equal to 1.5 mg/dl: Women: less than or equal to
             1.3 mg/dl.

          -  Urinalysis: negative or trace protein, negative glucose, less than or equal to 3 Red
             Blood Cells (RBC)/High Power Field (HPF) and less than or equal to 5WBC/HPF (in
             nonmenstruating females).

          -  Negative serum cryoglobulin

          -  Hepatitis B: negative Hepatitis B Surface Antigen (HBsAg) (using standard Food and
             Drug Administration FDA approved tests, e.g. Abbott or Organon).

          -  Hepatitis C: Anti-Hepatitis C Virus (HCV) negative and HCV Ribonucleic Acid (RNA)
             negative (using standard FDA approved tests, e.g. Abbott or Organon).

          -  HIV ELISA negative (using standard FDA approved tests, e.g. Abbott or Organon)
             (Written informed consent for HIV antibody testing will be obtained before obtaining
             the HIV sample.) Note: HIV vaccine volunteers who test positive by HIV ELISA and HIV
             western blot testing due to receipt of HIV vaccine may participate if they test
             negative by HIV DNA Polymerase Chain Reaction (PCR).

          -  Negative urine pregnancy test (females of child bearing potential) obtained at
             screening and at the day of each immunization.

          -  The ability to understand and sign a written informed consent document. Available for
             16 months after the first injection so that follow-up may be completed.

        Exclusion Criteria:

          -  Diabetes.

          -  Cancer other than squamous cell skin cancer which has been excised.

          -  History of myocardial infarction or arrhythmia requiring hospitalization.

          -  Syncope requiring hospitalization.

          -  Unconsciousness other than a simple concussion.

          -  Seizures other than febrile seizures as a child <5 years of age.

          -  Current liver disease (not including Gilbert's disease).

          -  Autoimmune disease (does not include thyroid disease or vitiligo).

          -  Splenectomy.

          -  Uncontrolled hypertension [blood pressure (BP) >150/90; anti-hypertensive medications
             are acceptable).

          -  Subjects with identifiable high-risk behavior for HCV infection as characterized by
             the following: injection drug use (IVDU) or cocaine snorting within the last year.

          -  Subject had a tattoo or body piercing within the past 6 months and/or is planning to
             acquire any tattoos or body piercing during the period of the study.

          -  Subjects with tattoos at the bilateral sites of needle insertion.

          -  Pregnant or lactating women. Women of child bearing potential must be using effective
             contraception for at least 30 days prior to initial immunization, unless for
             religious, social, or medical reasons they do not intend to have children and are
             practicing sexual abstinence. Subjects using birth control must agree to do so for the
             entire 64 week study period. Acceptable method of birth control is defined as hormonal
             contraceptives, intrauterine device (IUD), diaphragm with spermicide, condoms, a
             vasectomized partner or abstinence.

          -  Concomitant drug exclusion: corticosteroids (other than intranasal sprays or topical
             creams) or other known immunosuppressive drugs (such as chemotherapy for cancer); any
             experimental agent; any anti-tuberculosis medication, e.g., isoniazid (INH).

          -  Personnel engaged in the blinding of this study.

          -  Subjects who for any reason cannot adhere to the schedule of this protocol should not
             be enrolled in the study.

          -  Subjects who in the judgment of the investigator would not be good candidates due to
             medical, psychiatric, or social conditions which may interfere with or serve as a
             contradiction to adherence to the study protocol.

          -  Subjects with sex partners with known active Hepatitis B virus (HBV), HCV, or HIV
             infection.

          -  Currently abuses alcohol. Alcohol abuse is defined as requiring hospital admission for
             detoxification and therapy or alcohol use that has had a significant impact on
             personal relationships or ability to work productively.

          -  Not accessible by telephone or pager.

          -  Live attenuated immunization within 4 weeks of each vaccination.

          -  Inactivated immunization within 2 weeks of each vaccination.

          -  Febrile illness within 3 days of study entry based on verbal report by the subject.