Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults

This is an interventional prevention trial for Malaria focused on measuring PfSPZ Vaccine, Malaria, Plasmodium falciparum, Controlled human malaria infection Read More

Inclusion Criteria:

• Healthy adults (male or non-pregnant female) 18 to 50 years of age
• Able and willing to participate for the duration of the study
• Able and willing to provide written (not proxy) informed consent
• Physical examination and laboratory results without clinically significant findings
• Individuals of childbearing potential must agree to use effective means of birth control (e.g. oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) during the entire study. Female participants with a history of surgical or chemical sterilization (e.g. tubal ligation, hysterectomy, other) must provide written documentation of the procedure from a health care provider
• Willing to refrain from blood donation for 3 years following CHMI
• Agree not to travel to a malaria endemic region during the entire course of the trial

Exclusion Criteria:

• A history of malaria infection within 2 years prior to study participation or travel to a malaria endemic region within six months prior to first immunization
• Receipt of a malaria vaccine in a prior clinical trial
• History of a splenectomy or sickle cell disease
• History of a neurologic disorder (including non-febrile seizures or complex febrile seizures) or formal history of migraine headache
• Current use of systemic immunosuppressant pharmacotherapy
• Receipt of a live vaccine within 4 weeks of first immunization or of a non-live vaccine within 2 weeks of first immunization
• Individuals who are breast-feeding, pregnant or planning to become pregnant during the study period
• Known allergy to atovaquone-proguanil (Malarone®), artemether-lumefantrine (Coartem), or any component of the investigational products
• History of anaphylaxis or other life-threatening reaction to a vaccine
• Participation in any study involving investigational vaccine or drug within 4 weeks prior to enrollment
• Evidence of increased cardiovascular disease risk; defined as >10% five-year risk by non-laboratory method (Gaziano, 2008)
• Plan to participate in another investigational vaccine/drug research during the study
• Plan for major surgery between enrollment until 28 days post-CHMI
• Use or planned use of any drug with anti-malarial activity that would preceed or coincide with malaria challenge.
• Anticipated use of medications known to cause drug reactions with atovaquone-proguanil or artemether-lumefantrine such as cimetidine, metoclopramide, antacids, and kaolin
• Positive HIV, HBV or HCV infection
• An abnormal electrocardiogram, defined as one showing pathologic Q waves and significant ST-T wave changes; left ventricular hypertrophy; any non-sinus rhythm including isolated premature ventricular contractions, but excluding isolated premature atrial contractions; right or left bundle branch block; or advanced (secondary or tertiary) A-V heart block; or other clinically significant abnormalities on the electrocardiogram as determined by the consulting cardiologist
• Any clinically significant deviation from the normal range in biochemistry or hematology tests measured at screening and not resolving.
• Any medical, psychiatric, social, behavioral or occupational condition or situation (including active alcohol or drug abuse) that, in the judgment of the PI, impairs the volunteer's ability to give informed consent, increases the risk to the subject of participation in the study, affects the ability of the subject to participate fully in the study, or might negatively impact the quality, consistency, integrity or interpretation of data derived from their participation in the study