Safety, Tolerability, and Immunogenicity Study of Sm-p80 + GLA-SE (SchistoShield(R)) Vaccine in Healthy Adults

Inclusion Criteria

• Male or non-pregnant female 18 through 55 years of age, inclusive, at the time of consent.
• Able and willing to participate for the duration of the study and able to understand and comply with planned study procedures.
• Able and willing to provide written (not proxy) informed consent.
• Is in good health, as judged by the investigator, and determined by medical history and physical examination*.

*Existing medical diagnoses or conditions (except those in the Subject Exclusion Criteria) must be deemed as stable. A stable medical condition is defined as no change in prescription medication, dose, or frequency of medication in the last three months (90 days) and health outcomes of the specific disease are considered to be within acceptable limits in the last six months (180 days). Any change due to change of health care provider, insurance company, or that is done for financial reasons, as long as in the same class of medication, will not be considered a violation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site PI or appropriate sub-investigator, will not be considered a violation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site PI or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of solicited events and immunogenicity. Topical, nasal, and inhaled medications (with the exception of some uses of corticosteroids as outlined in the Subject Exclusion Criteria), vitamins, and contraceptives are permitted.

• Women of childbearing potential* must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to each study product injection.

*Not sterilized via bilateral tubal ligation, bilateral oophorectomy, or hysterectomy, or, if menopausal, still menstruating or /= 50 kg and body mass index (BMI) /=3.80 x10^3/UL and </=13.00 x10^3/UL, (d) hemoglobin 11.5 g/dL or greater for females or 12.6 g/dL or greater for males, (e) platelets between 131 x10^3/UL and 415 x10^3/UL, inclusive.

Exclusion Criteria

• Has had known schistosomiasis infection or has traveled to an endemic area for schistosomiasis infection and, during that travel, was potentially exposed to a Schistosoma species.
• Has been treated for schistosomiasis.
• Has previous exposure to schistosome vaccines or experimental products containing GLA-SE.
• Female subjects who are breastfeeding a child ,or who plan to breastfeed a child from the first study product injection through 30 days after the last study product injection.
• Asthma, other than mild, well-controlled asthma*

*Cold or exercise-induced asthma controlled with inhaled medications other than inhaled corticosteroids is permissible. Subjects should be excluded if they require daily bronchodilator use, or have had an asthma exacerbation requiring oral/parenteral steroid use or have used theophylline or inhaled corticosteroids in the past year

• Known atherosclerotic cardiovascular disease or history of myocardial infarction, pericarditis, or myocarditis.
• Diabetes mellitus
• History of a psychiatric condition that may make study compliance difficult, such as schizophrenia, or poorly controlled bipolar disorder**

**Includes persons with psychoses or history of suicide attempt or gesture in the 3 years before study entry or an ongoing risk for suicide.

• Chronic or active neurologic condition (including seizures*** and migraine headaches****).

***Seizure within the past 5 years

****Four or more migraine headaches in the past 12 months that interfered with normal daily activity or any migraine headache in the past 5 years that required emergency or inpatient medical care.

• Autoimmune disease******

******autoimmune hypothyroidism with or without replacement therapy, and vitiligo or mild eczema or psoriasis not requiring chronic ther