Efficacy, Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Evaluating Different Dose Schedules in a Sporozoite Challenge Model in Healthy Malaria-naïve Adults

Exclusion Criteria

• •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day -29 to Day 0), or planned use during the study period.
• •Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
• •Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
• •Administration of long-acting immune-modifying drugs at any time during the study period.
• •Chronic use of antibiotics with antimalarial effects.
• •Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting seven days before the first dose.
• •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
• •Seropositive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
• •Documented HIV-positive subject.
• •Previous vaccination against malaria.
• •History of malaria chemoprophylaxis within 60 days prior to vaccination.
• •Any history of malaria (for the vaccine groups).
• •Planned travel to malaria endemic areas during the study period.
• •History of splenectomy.
• •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• •Family history of congenital or hereditary immunodeficiency.
• •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
• •History of anaphylaxis post-vaccination.
• •Hypersensitivity to latex.
• •History of any reaction or hypersensitivity 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.
• •History of severe reactions to mosquito bites.
• •Major congenital defects.
• •Serious chronic illness.
• •History of any neurological disorders or seizures.
• •Acute disease and/or fever at the time of enrolment. Fever is defined as temperature ≥ 37.5°C/99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C/100.4°F for rectal route.
• •\- 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: alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, hemoglobin, platelet count, total white blood cells (WBC), out of normal range as defined in the protocol.
• •Evidence of increased cardiovascular disease risk, "moderate" or "high", according to the National health and nutrition examination survey I criteria.
• •Hepatomegaly, right upper quadrant abdominal pain or tenderness.
• •Personal history of autoimmune disease.
• •Administration of immunoglobulins and/or any blood products during the period starting three months before the first dose of study vaccine or planned administration during the study period.
• •Pregnant or lactating female.
• •History of chronic alcohol consumption and/or drug abuse.
• •Female planning to become pregnant or planning to discontinue contraceptive precautions.
• •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.