| Eligibility |
Inclusion Criteria:
1. Male or non-pregnant female 18 through 55 years of age, inclusive, at the time of
consent.
2. Able and willing to participate for the duration of the study and able to understand
and comply with planned study procedures.
3. Able and willing to provide written (not proxy) informed consent.
4. 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.
5. 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 < 1 year of the last menses
6. Women of childbearing potential must have used an acceptable form of contraception* in
the 30 days prior to their first study product injection.
*Acceptable single forms of contraception include abstinence from sexual activity that
could lead to pregnancy, monogamous relationship with vasectomized partner who has
been vasectomized for six months or more prior to enrollment, successful Essure
placement (permanent, non-surgical, non-hormonal sterilization), intrauterine devices,
and hormonal methods, including the birth control patch, shot (Depo-Provera), pills,
the vaginal ring (NuvaRing), and the contraceptive implant (Nexplanon). Acceptable
barrier methods include diaphragm or cervical cap with spermicide and the
contraceptive sponge.
7. Women of childbearing potential must agree to continue use of an acceptable form of
contraception through 30 days after their last study product injection.
8. Weight >/= 50 kg and body mass index (BMI) < 35.0 kg/m2
9. Vital signs (oral temperature, pulse, and blood pressure) are all within normal
protocol-defined ranges.*
*The normal protocol-defined ranges for vital signs include (a) oral temperature less
than 38 degrees C (100.4 degrees F), (b) pulse no greater than 100 bpm, (c) systolic
blood pressure 85 to 150 mmHg, inclusive, and (d) diastolic BP </= 100 mmHg.
10. Screening clinical lab values are all within normal protocol-defined reference ranges.
- The normal protocol-defined ranges for laboratory tests include (a) ALT of < 47
IU/L, (b) creatinine less than or equal to the laboratory upper limit of normal,
(c) WBC >/=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:
1. 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.
2. Has been treated for schistosomiasis.
3. Has previous exposure to schistosome vaccines or experimental products containing
GLA-SE.
4. 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.
5. 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
6. Known atherosclerotic cardiovascular disease or history of myocardial infarction,
pericarditis, or myocarditis.
7. Diabetes mellitus
8. 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.
9. 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.
10. Autoimmune disease******
******autoimmune hypothyroidism with or without replacement therapy, and vitiligo or
mild eczema or psoriasis not requiring chronic therapy, are permissible
11. Known or suspected congenital or acquired immunodeficiency including anatomic or
functional asplenia******* or immunosuppression as a result of underlying illness or
treatment.
*******Any splenectomy is exclusionary.
12. Use of alcohol or drugs that, in the opinion of the investigator, may interfere with
ability to comply with the protocol or increase risk to subject's health during the
study period.
13. Active neoplastic disease********
********Subjects with a history of malignancy may be included if treated by surgical
excision, or by chemotherapy or radiation therapy and has been observed for a period
that in the investigator's estimation provides a reasonable assurance of sustained
cure (not less than 36 months). Cervical neoplasia under surveillance and non-melanoma
skin cancer are not exclusionary.
14. Chronic topical or systemic corticosteroid use*********
*********Corticosteroid nasal sprays for allergic rhinitis are permissible. Persons
using a topical corticosteroid for a limited duration for mild uncomplicated
dermatitis such as poison ivy or contact dermatitis prior to enrollment may be
enrolled the day after their therapy is completed. Oral or parenteral (intravenous,
IM, subcutaneous) corticosteroids given for non-chronic conditions not expected to
recur are permissible if, within the year prior to enrollment, the longest course of
therapy was no more than 14 days and no oral or parenteral corticosteroids were given
within 30 days prior to enrollment. Intraarticular, bursal, tendon, or epidural
injections of corticosteroids are permissible if the most recent injection was at
least 30 days prior to enrollment. Topical or systemic corticosteroid use for study
related AEs is not exclusionary.
15. Known contraindication to repeated phlebotomy**********
**********Such as minimal venous access or recent history of anemia
16. Receipt or planned receipt of inactivated vaccine or allergy desensitization injection
within 14 days before or after a study product injection.
17. Receipt or planned receipt of live attenuated vaccine within 28 days before or after a
study product injection.
18. Receipt of blood products or immunoglobulin within six months prior to, or donation of
a unit of blood within two months prior to, the first study product injection.
19. Receipt of any experimental agent*********** within 30 days prior to screening or
planned receipt prior to the last study visit-**.
***********Vaccine, drug, biologic, device, blood product, or medication.
**Receipt of experimental COVID-19 related products are not necessarily exclusionary
and will be evaluated on a case-by-case basis.
20. Plan to undergo surgery (elective or otherwise) within six months after study
enrollment.
21. Plans to enroll in another interventional clinical trial************ at any time
during the study period.
************Includes trials evaluating interventions such as a drug, biologic, or
device.
22. Positive confirmatory test for HIV infection.
23. Positive serologic test for hepatitis B surface antigen (HBsAg).
24. Positive confirmatory test for hepatitis C virus (HCV) infection.
25. Acute febrile illness (oral temperature = 38°C) or other acute illness within three
days prior to study product injection.*************
*************Note for afebrile, acute illness only: If a subject is afebrile, his/her
acute illness is nearly resolved with only minor residual symptoms remaining, and, in
the opinion of the site PI or appropriate sub-investigator, the residual symptoms will
not interfere with the ability to assess safety parameters as required by the
protocol, the subject may receive study product injection without further approval
from the DMID Medical Officer.
26. Not willing to avoid donating blood during the study.
27. Has any condition that would, in the opinion of the site investigator, place the
subject at an unacceptable risk of injury or render the subject unable to meet the
requirements of the protocol.
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