Trial to Evaluate L9LS in Healthy Adults

INCLUSION CRITERIA

A volunteer must have met all of the following criteria to be included:

• Able and willing to complete the informed consent process
• Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
• Available for clinical follow-up through the last study visit
• 18 to 50 years of age
• In good general health without clinically significant medical history
• Physical examination without clinically significant findings within the 56 days prior to enrollment
• Weight 10% five-year risk by the non-laboratory method (except Group 6)

Criteria Specific to Women:

• Postmenopausal for at least 1 year, post-hysterectomy or bilateral oophorectomy, or if of childbearing potential:
• Negative beta-human chorionic gonadotropin (beta-HCG) pregnancy test (urine or serum) on day of enrollment, and prior to product administration and CHMI, and
• Agrees to use an effective means of birth control through the duration of study participation

EXCLUSION CRITERIA

A volunteer would have been excluded if one or more of the following conditions applied:

• Woman who is breast-feeding or planning to become pregnant during study participation
• Previous receipt of a malaria vaccine or anti-malaria monoclonal antibody
• History of malaria infection
• Any history of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis prior to enrollment that has a reasonable risk of recurrence during the study
• Hypertension that is not well controlled
• Receipt of any investigational study product within 28 days prior to enrollment/product administration (Note: SARS-CoV-2 vaccines approved by emergency use authorization are not exclusionary)
• Receipt of any live attenuated vaccines within 28 days prior to enrollment/product administration
• Receipt of any vaccine within 2 weeks prior to enrollment/product administration
• Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with intramuscular injections or blood draws
• History of a splenectomy, sickle cell disease or sickle cell trait
• History of skeeter syndrome or anaphylactic response to mosquito-bites (except Group 6)
• Known intolerance to chloroquine phosphate, atovaquone or proguanil (except Group 6)
• Use or planned use of any drug with antimalarial activity that would coincide with study product or CHMI (except Group 6)
• History of psoriasis or porphyria, which may be exacerbated after treatment with chloroquine (except Group 6)
• Anticipated use of medications known to cause drug reactions with chloroquine or atovaquone-proguanil (Malarone) such as cimetidine, metoclopramide, antacids, and kaolin
• History of Sjogren's Syndrome
• History of chronic or recurrent salivary gland disorder diagnosed by a clinician (note: an isolated occurrence of parotitis, sialadenitis, sialolithiasis, or of a salivary gland tumor is not exclusionary)
• History of therapeutic head or neck radiation
• Any other chronic or clinically significant medical condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer, including but not limited to: diabetes mellitus type I, chronic hepatitis; OR clinically significant forms of: drug or alcohol abuse, asthma, autoimmune disease, infectious diseases, psychiatric disorders, heart disease, or cancer