Clinical trial NCT01018459 (phase 1, status: completed)
Conditions: malaria
ICD codes: B54, B53.0, P37.3, P37.4, B50.9, Z86.13, B51.9
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:

          -  Provision of informed consent before any protocol procedures are performed.

          -  Males and non-pregnant, non-lactating females between the ages of 18 and 45 years,
             inclusive.

          -  Females and males must agree to practice adequate contraception until at least 28 days
             following their last immunization dose (including abstinence; hormonal contraception;
             condoms with spermicidal agents; post-menopausal; or surgical
             sterilization/vasectomy).

          -  Participants must agree to avoid high risk sexual behavior for exposure to human
             immunodeficiency virus (HIV).

          -  In good health as determined by screening medical history, physical examination (PE),
             and laboratory assessments.

          -  Willingness to comply with protocol requirements.

          -  Willingness to be contacted for one year for assessment of serious adverse events.

          -  Must be a permanent resident of the Saponé health district (villages around Balonghin)
             in Burkina Faso.

        Exclusion Criteria:

          -  Current or recent (within the last four weeks) treatment with parenteral, inhaled, or
             oral corticosteroids (intranasal steroids are acceptable), or other immunosuppressive
             agents, or chemotherapy.

          -  History of splenectomy.

          -  Abnormal screening laboratory values. Any abnormal screening value for any screening
             test will exclude the subject from the study. Abnormal screening labs will not be
             repeated with the exception of high glucose levels will be repeated at a fasting
             state.

          -  History of intravenous (IV) drug abuse.

          -  History of, or current medical, occupational, social or family problems as a result of
             alcohol or illicit drug use.

          -  History of moderate to severe mental illness, as defined by symptoms interfering with
             social or occupational function or suicidal thoughts/attempts.

          -  History of receiving blood or blood products (such as blood transfusion, platelet
             transfusion, immunoglobulins, hyperimmune serum) in the previous 6 months.

          -  Vaccination with a live vaccine within the past 30 days or with a nonreplicating,
             inactivated, or subunit vaccine within the last 14 days.

          -  Known hypersensitivity to components of the vaccine.

          -  History of acute or chronic medical conditions including, but not limited to,
             disorders of the liver, kidney, lung, heart, or nervous system, or other metabolic or
             autoimmune/inflammatory conditions.

          -  History of coagulation defect or bleeding from (bruising at) multiple sites that
             cannot be linked to trauma or surgery.

          -  History of anaphylaxis or severe hypersensitivity reaction.

          -  Severe asthma, as defined by an emergency room visit or hospitalization within the
             last 12 months.

          -  Pregnant or breastfeeding women.

          -  Acute illness, including temperature >37.8 degrees Celsius within one week prior to
             vaccination.

          -  Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or
             hepatitis B surface antigen (HBsAg).

          -  Concurrent participation in other investigational protocols or receipt of an
             investigational product within the previous 30 days or planned receipt of an
             investigational product within 28 days following the last immunization dose.

          -  Identification of any condition that, in the opinion of the investigator, would affect
             the ability of the subject to understand or comply with the study protocol or would
             jeopardize the safety or rights of a subject participating in the study.

          -  History of malignancy, including hematologic and skin cancers (except for a localized
             basal cell carcinoma), or known immunodeficiency syndrome.

          -  History of previous receipt of a malaria vaccine.

          -  Pre-medication with analgesic or antipyretic agents in the 6 hours prior to
             vaccination, or planned medication with analgesic or antipyretic in the 24 hours
             following vaccination. This criterion should not preclude subjects receiving such
             medication if the need arises.

          -  Receipt of a recombinant adenovirus vector vaccine in a prior study.