Clinical trial NCT02315703 (phase 1/phase 2, status: active, not recruiting)
Conditions: healthy
ICD codes: Z76.3, Z76.2
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:

          -  Participant must be healthy on the basis of physical examination, medical history,
             electrocardiogram (ECG) and laboratory criteria, and vital signs measurement performed
             at Screening

          -  Participants are negative for human immunodeficiency virus (HIV) infection at
             Screening

          -  All female participants of childbearing potential must have a negative serum (beta
             human chorionic gonadotropin) at Screening, and a negative urine pregnancy test
             pre-dose on Week 0, 12, 24, and 48

          -  A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted
             reproduction until 3 months after receiving the last dose of study vaccine. A man must
             agree not to donate sperm until 3 months after receiving the last dose of study
             vaccine

          -  Participants are assessed by the clinic staff as being at low risk for HIV infection

        Exclusion Criteria:

          -  Participant has chronic active hepatitis B or active hepatitis C, active syphilis
             infection, chlamydia, gonorrhea, or trichomonas. Active syphilis documented by exam or
             serology unless positive serology is due to past treated infection

          -  In the 12 months prior to enrollment, participant has a history of newly acquired
             herpes simplex virus type 2 (HSV-2), syphilis, gonorrhea, non-gonococcal urethritis,
             chlamydia, pelvic inflammatory disease, trichomonas, mucopurulent cervicitis,
             epididymitis, proctitis, lymphogranulomavenereum, chancroid, or hepatitis B

          -  Participant has any clinically significant acute or chronic medical condition that in
             the opinion of the investigator would preclude participation (for example, history of
             seizure disorders, bleeding/clotting disorder, autoimmune disease, active malignancy,
             poorly controlled asthma, active tuberculosis or other systemic infections)

          -  Participant has had major surgery within the 4 weeks prior to study entry or planned
             major surgery through the course of the study

          -  Participant has had a thyroidectomy, or thyroid disease requiring medication during
             the last 12 months

          -  Participant has a history of myocarditis, pericarditis, cardiomyopathy, congestive
             heart failure with permanent sequelae, clinically significant arrhythmia (including
             any arrhythmia requiring medication, treatment, or clinical follow up)

          -  Participant has an ECG (per examination and interpretation of a cardiologist) with
             clinically significant findings, or features that would interfere with the assessment
             of myo/pericarditis, including any of the following: a) conduction disturbance
             (complete left or complete right bundle branch block or nonspecific intraventricular
             conduction disturbance with QRS >=120 millisecond [ms], PR interval >=220 ms, any 2nd
             or 3rd degree AV block, or QTc prolongation [>450 ms]); b) significant repolarization
             (ST segment or T wave) abnormality; c) significant atrial or ventricular arrhythmia,
             frequent atrial or ventricular ectopy (for example frequent premature atrial
             contractions, 2 premature ventricular contractions in a row); d) ST elevation
             consistent with ischemia, or evidence of past or evolving myocardial infarction

          -  Participant has a history of anaphylaxis or other serious adverse reactions to
             vaccines or vaccine products, or neomycin or streptomycin or egg products