PpPfs25/ISA51 and ScPvs25/ISA51 Vaccines for Malaria

Exclusion Criteria

• •Pregnancy as determined by a positive urine human chronic gonadotrophin (B-hCG), if female.
• •Volunteer unwilling to use reliable contraception methods for the duration of the trial, if female. (Reliable methods of birth control include: pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide, diaphragm with spermicide, surgical sterilization, intrauterine device, abstinence, and post-menopause)
• •Currently breast-feeding (if female).
• •Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the volunteer to understand and cooperate with the study protocol.
• •Laboratory evidence of liver disease (aspartate aminotransferase \[AST\] and/or alanine aminotransferase \[ALT\] greater than the upper limit of normal of the testing laboratory).
• •Laboratory evidence of renal disease (serum creatinine greater than the upper limit of normal of the testing laboratory).
• •Laboratory evidence of hematologic disease (absolute neutrophil count less than 1,500/mm(3); hemoglobin less than the lower limit of normal of the testing laboratory, by sex; or platelet count less than 140,000/mm(3)).
• •Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urinalysis (greater than trace protein, or any glucose on urine dip will be confirmed negative prior to enrollment).
• •Other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.
• •Participation in another investigational vaccine or drug trial within 30 days of starting this study, or while this study is ongoing.
• •Volunteer has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
• •History of a severe allergic reaction or anaphylaxis.
• •Positive ELISA and confirmatory Western blot tests for HIV-1.
• •Positive ELISA and confirmatory immunoblot tests for HCV.
• •Positive HBsAg by ELISA.
• •Known immunodeficiency syndrome.
• •Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of starting this study or while the study is ongoing.
• •Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to entry into the study.
• •History of a surgical splenectomy.
• •Receipt of blood products within the past 6 months.
• •Previous receipt of an investigational malaria vaccine.
• •History of a known allergy to nickel.