Study of Controlled Human Malaria Infections to Evaluate Protection After Intravenous or Intramuscular Administration of PfSPZ Vaccine in Malaria-Naive Adults

Exclusion Criteria

• •A volunteer will be excluded if one or more of the following conditions apply:
• •1. Woman who is breast-feeding or planning to become pregnant during the time interval needed to complete the study.
• •2. Receipt of a malaria vaccine in a prior clinical trial.
• •3. Any history of malaria infection.
• •4. Evidence of increased cardiovascular disease risk; defined as \>10% five year risk by the non-laboratory method.
• •5. Current use of systemic immunosuppressant pharmacotherapy.
• •6. History of a splenectomy, sickle cell disease or sickle cell trait.
• •7. Plan for major surgery between enrollment and challenge.
• •8. Known allergy to any component of the vaccine formulation; history of anaphylactic response to mosquito-bites; or known allergy to chloroquine phosphate, atovaquone or proguanil.
• •9. Participation in any study involving another investigational vaccine or drug within 12 weeks prior to enrollment, or plan to participate in another investigational vaccine/drug research during the study.
• •10. Personal beliefs that prohibit the receiving of vaccine product containing human serum albumin within the diluent.
• •11. Use or planned use of any drug with anti-malarial activity that would coincide with study vaccination or challenge.
• •12. History of psoriasis or porphyria, which may be exacerbated after treatment with chloroquine.
• •13. Anticipated use of medications known to cause drug reactions with chloroquine or atovaquone-proguanil (Malarone) such as cimetidine, metoclopramide, antacids, and kaolin.
• •14. Psychiatric condition that precludes compliance with the protocol; past or present psychoses; disorder requiring lithium; or within five years prior to enrollment, history of a suicide plan or attempt.
• •15. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer s ability to give informed consent or to comply with the protocol schedule.