Safety, Immunogenicity and Efficacy Against of a Combined Malaria Vaccine in Healthy Malaria-naïve Adults

Exclusion Criteria

• •Use of any investigational or non-registered product within 30 days preceding the first dose of study vaccine, or planned use of any investigational or non-registered product other than the study vaccines during the study period.
• •Planned administration/ administration of a vaccine not foreseen by the study protocol within 7 days of the first dose of vaccines.
• •Prior receipt of an investigational malaria or adenovirus vaccine.
• •Chronic use of antibiotics with antimalarial effects.
• •History of malaria chemoprophylaxis within 60 days prior to vaccination.
• •Any history of malaria.
• •Planned travel to malaria endemic areas during the study period.
• •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s) including latex.
• •History of allergic disease or reactions likely to be exacerbated by chloroquine.
• •History of psoriasis and porphyria, which may be exacerbated after chloroquine treatment.
• •Current use of medications known to cause drug reactions to chloroquine, such as antacids and kaolin.
• •Any history of anaphylaxis in reaction to any previous vaccination.
• •History of severe reactions to mosquito bites.
• •Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
• •Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to first vaccine dose.
• •Any confirmed or suspected immunosuppressive or immunodeficient condition, including immunodeficiency virus (HIV) infection.
• •Family history of congenital or hereditary immunodeficiency.
• •History of splenectomy.
• •Major congenital defects or serious chronic illness.
• •History of any neurological disorders or seizures.
• •Acute disease and/or fever at the time of enrollment.
• •Acute disease is defined as the presence of a moderate or severe illness with or without fever. Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
• •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• •Any abnormal baseline laboratory screening tests.
• •Evidence of increased cardiovascular disease risk, "moderate" or "high", according to the NHANES I criteria.
• •An abnormal baseline screening electrocardiogram (EKG).
• •Hepatomegaly, right upper quadrant abdominal pain or tenderness.
• •Personal history of autoimmune disease.
• •Seropositive for hepatitis B surface antigen or Hepatitis C virus (antibodies to HCV).
• •Pregnant or lactating female.
• •Female who intends to become pregnant during the study or planning to discontinue contraceptive measures.
• •Suspected or known current alcohol abuse.
• •Chronic or active intravenous drug use.
• •History of blood donation within 56 days preceding enrolment.
• •Any other significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome from participating in this study.