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

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.

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

What this study is about

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

What this study is about