Clinical trial NCT01169077 (phase 1, status: completed)
Conditions: plasmodium falciparum malaria
ICD codes: B50.9, B50.0, B50.8
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:

          -  Men and women, 18 through 40 years old, who deny exposure to or infection with malaria
             or prior participation in a malaria vaccine study.

          -  In good health, defined as a person who consents to participate in the trial, agrees
             to not donate blood until 6 months following the last blood draw in the protocol, and
             whose clinical laboratory assessments are within parameters as specified in this
             protocol in Appendix C, (Acceptable Screening Laboratory Ranges). (Women of
             childbearing potential (not surgically sterile or postmenopausal for >/= 1 year) must
             not be pregnant as indicated by a negative pregnancy test (urine or serum) within 24
             hours prior to vaccine administration.

          -  Women of childbearing potential who are at risk of becoming pregnant must agree to
             practice adequate contraception (i.e., barrier methods in conjunction with spermicidal
             gel, abstinence, monogamous relationship with vasectomized partner, intrauterine
             devices, Depo-Provera, Norplant, oral contraceptives, contraceptive patches or other
             licensed, effective methods) until 30 days following receipt of the last dose of
             vaccine.

          -  Able to understand and comply with planned study procedures.

          -  Able to provide informed consent prior to initiation of any study procedures and be
             available for all study visits.

          -  Have access to a telephone.

        Exclusion Criteria:

          -  Prior history of travel to a malaria-endemic area.

          -  History of previous malaria infection.

          -  Planned travel to a malaria-endemic area during the course of the study.

          -  History of splenectomy.

          -  Known hypersensitivity to components of the vaccine (deoxyribonucleic acid,
             phosphate-buffered saline, potassium dihydrogen phosphate, sodium hydrogen phosphate)
             or to kanamycin or other aminoglycoside antibiotics.

          -  Is female of child-bearing potential who is breastfeeding or intends to become
             pregnant during the study period up to 30 days following receipt of the last dose of
             vaccine.

          -  Has immunosuppression as a result of an underlying illness or treatment with
             immunosuppressive or cytotoxic drugs, or use of anticancer radiation therapy within
             the preceding 60 months.

          -  History of significant cardiac abnormality and/or abnormal baseline electrocardiogram
             (ECG) readout, and/or history of arrhythmia, including any cardiac pre-excitation
             syndromes (such as Wolff Parkinson White) or other cardiac syndromes or diseases (such
             as congestive heart failure) associated with arrhythmias, a history of syncopal
             episodes, and/or family history of prolonged QTc syndrome.

          -  Subjects with a seizure disorder, except for those who have been seizure free for 5
             years or are felt to be at low risk for seizure as determined by their neurologist
             (the effects of electric field generation near sites where the threshold of field
             sensitivity is low is unknown).

          -  Subjects with hemophilia, thrombocytopenia, bleeding or clotting disorders, muscular
             atrophy or muscular/neuromuscular degenerative disorders.

          -  Presence of any implanted any electronic stimulation device, such as cardiac demand
             pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep
             brain stimulators.

          -  Individuals in which a skin-fold measurement of the cutaneous and subcutaneous tissue
             for all eligible injection sites (deltoid muscles with intact lymph drainage) exceeds
             40 millimeters.

          -  Presence of surgical or traumatic metal implant in the upper limb and/or upper torso.

          -  Subjects with tattoos, lesions, rashes, scars or tumors at the proposed sites of
             administration.

          -  Has an active neoplastic disease (excluding non-melanoma skin cancer or prostate
             cancer that is stable in the absence of therapy) or a history of any hematologic
             malignancy. Active is defined as: no neoplastic disease or treatment for neoplastic
             disease within the past 5 years.

          -  Has long-term use (greater than 2 weeks) of oral or parenteral steroids, or high-dose
             inhaled steroids (greater than 800 micrograms per day of beclomethasone dipropionate
             or equivalent) within the preceding 6 months (nasal and topical steroids are allowed).

          -  Has a history of receiving immunoglobulin or other blood products within the 3 months
             prior to enrollment in this study.

          -  Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or
             4 weeks (for live vaccines) prior to enrollment in this study, or plans to receive any
             other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live
             vaccines) following each study vaccination.

          -  Has an acute or chronic medical condition that, in the opinion of the investigator,
             would render vaccination unsafe or would interfere with the evaluation of responses
             (this includes, but is not limited to: known cardiac arrhythmia or coronary artery
             disease, known chronic liver disease, significant renal disease, unstable or
             progressive neurological disorders, diabetes mellitus, and transplant recipients,
             bleeding disorders, or skin conditions, e.g. psoriasis).

          -  Has a history of severe reactions suggesting anaphylaxis following any previous
             vaccination.

          -  Has an acute illness or has an oral temperature greater than 99.9 degrees Fahrenheit
             (37.7 degrees Celsius) within 3 days prior to enrollment.

          -  Has received an experimental agent (vaccine, drug, biologic, device, blood product, or
             medication) within 1 month prior to enrollment in this study, or expect to receive an
             experimental agent during the study period.

          -  Has any condition that would, in the opinion of the site principal investigator, place
             the subject at an unacceptable risk of injury or render the subject unable to meet the
             requirements of the protocol.

          -  Has a diagnosis of schizophrenia, bipolar disease or other severe (disabling) chronic
             psychiatric diagnosis.

          -  Has been hospitalized for psychiatric illness, history of suicide attempt or
             confinement for danger to self or others.

          -  Is receiving psychiatric drugs (aripiprazole, clozapine, ziprasidone, haloperidol,
             molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone,
             mesoridazine, quetiapine, trifluoperazine, trifluopromazine, chlorprothixene,
             chlorpromazine, perphenazine, olanzapine, carbamazepine, divalproex sodium, lithium
             carbonate or lithium citrate). Subjects who are receiving a single antidepressant drug
             and are stable for at least 3 months prior to enrollment without decompensating are
             allowed enrollment into the study.

          -  Positive serology for human immunodeficiency virus, hepatitis B, or hepatitis C
             infection.

          -  Abnormal values on clinical safety laboratory tests obtained during screening.

          -  Has a history of alcohol or drug abuse in the 5 years prior to enrollment.

          -  Has a history of Guillain-Barré syndrome.

          -  Has any condition that the investigator believes may interfere with successful
             completion of the study.

          -  Plans to enroll in another clinical trial at any time during the study period.