A Trial For The Study of Falciparum Malaria Protein 013 Administered Via Intramuscular Injection in Healthy Adults

Exclusion Criteria

• •1. History of malaria infection (any species) or residence in a malaria-endemic area for more than 5 years (includes previous participation in CHMI studies).
• •2. Previous travel to malaria endemic regions within the past 6 months before study enrollment defined as first vaccination or day of challenge (for infectivity controls) or planned travel to malaria endemic regions during the vaccination, CHMI and 28-day CHMI follow-up period; For Travel outside the US occurring 28 days post-challenge to a malaria endemic area exclusion will be at the discretion of the PI.
• •3. Any history of receiving a malaria vaccine.
• •4. Received an investigational product in the 30 days before enrollment, or planned to receive during the study period.
• •5. Concurrent participation in another clinical research study.
• •6. Any use of medications that prevent or treat malaria during the 1 month prior to challenge or planned use during the study (outside of the drugs provided by the study team).
• •7. Any serious medical illness or condition involving the heart, liver, lungs, or kidneys.
• •8. Any significant risk for developing heart disease in the next 5 years, assessed according to clinical Gaziano (NHANES I) criteria assessed at screening, and an ECG.
• •9. Receipt of immunoglobulins or blood products within 3 months before enrollment.
• •10. Any history of anaphylaxis.
• •11. History of sickle cell trait or disease, or any condition that could affect susceptibility to malaria infection, per subject verbal report.
• •12. Pregnancy, lactation, or intention to become pregnant during the study, and 3 months after malaria challenge, if applicable.
• •13. Contraindications or allergies to the use of all 3 proposed anti-malarial medications; Malarone (atovaquone/proguanil), Coartem (artemether/lumefantrine) and chloroquine; contraindication to 1 or 2 is not exclusionary.
• •14. History of active/recent cancer still within treatment or active surveillance follow-up (except basal cell carcinoma of the skin and cervical carcinoma in situ). Treated/resolved cancers with no likelihood of recurrence may be deemed acceptable at Principal investigator discretion
• •15. History of autoimmune disease.
• •16. Significant (eg systemic anaphylaxis) hypersensitivity reactions to mosquito bites (local reactions at the site of mosquito bites are not an exclusion criterion) requiring hospitalization.
• •17. Suspected or known current alcohol or drug abuse as defined by an alcohol intake of greater than 3 drinks a day on average for a man, and greater than 2 drinks a day on average for a woman.
• •18. Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to give informed consent, participate in the study, or impair interpretation of the study data, in the opinion of the Investigator.
• •19. Current anti-tuberculosis prophylaxis or treatment.
• •20. History of splenectomy.
• •21. History of confirmed or suspected immunodeficiency.
• •22. History of Hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema.
• •23. History of Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past 2 years.
• •24. History of Diabetes mellitus (type I or II), with the exception of gestational diabetes.
• •25. History of Thyroid disease (except for well controlled hypothyroidism).
• •26. History of Idiopathic urticaria within the past year.
• •27. History of hypertension that is not well controlled by medication or that is persistently greater than 150/95 at screening...
• •28. History of bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
• •29. History of chronic or active neurologic disease to include seizure disorder and chronic migraine headaches. Exceptions are: i) childhood febrile seizures, or ii) seizures secondary to alcohol withdrawal more than 3 years ago.
• •30. Subjects receiving any of the following substances:
• •* Systemic immunosuppressive medications or cytotoxic medications within 12 weeks before enrollment \[with the exception of a short course of corticosteroids (≤ 14 days duration or a single injection) for a self-limited condition at least 2 weeks before enrollment; inhaled, intranasal or topical steroids are not considered exclusionary\]
• •* Treatment with known immunomodulators (other than nonsteroidal anti-inflammatory drugs \[NSAIDs\]) for any reason.
• •* History of receipt of medication that prevent or treat malaria within 1 month of CHMI
• •* Live attenuated vaccines within 30 days before initial study vaccine administration
• •* Medically indicated subunit or killed vaccines, eg, influenza, pneumococcal, or allergy treatment with antigen injections, planned for administration 14 days before or after study vaccine administration
• •31. History of arthritis diagnosis other than osteoarthritis.
• •32. History of other diagnosed rheumatoid disorders.
• •33. Any history of psoriasis (itchy skin rash) or porphyria (rare disturbance of metabolism), since these conditions could get worse after treatment with chloroquine (a medication for treating malaria).
• •34. Subject must not have a fever in order to receive the study vaccine or participate in the malaria challenge.