| Eligibility |
Inclusion Criteria:
1. Provide written informed consent prior to any study procedures.
2. Able to understand and comply with planned study procedures and be available for all
study visits.
3. Male or non-pregnant female aged 18 to 50, inclusive at the time of enrollment.
4. Are in good health, as determined by vital signs (oral temperature, pulse, and blood
pressure), medical history, and brief physical examination at screening.
-Existing medical diagnoses or conditions (except those in the Subject Exclusion
Criteria) must be deemed as stable chronic medical conditions. A stable chronic
medical condition is defined as no change in prescription medication, dose, or
frequency of medication in the last 3 months (90 days) and health outcomes of the
specific disease are considered to be within acceptable limits in the last 6 months
(180 days). Any change due to change of health care provider, 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 principal investigator or
appropriate sub-investigator, will not be considered a violation of this inclusion
criterion. Subjects may be on chronic or as needed medications if, in the opinion of
the site principal investigator or appropriate sub-investigator, they pose no
additional risk to subject safety or assessment of reactogenicity and immunogenicity.
Topical, nasal, and inhaled medications (with the exception of corticosteroids as
outlined in the Subjects Exclusion Criteria), vitamins, and contraceptives are
permitted.
5. 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 38.0 degrees celsius, (b) pulse 50 to 100 bpm, inclusive, (c) systolic blood
pressure 85 to 150 mmHg, inclusive, and (d) diastolic blood pressure 55 to 90 mmHg,
inclusive. Pulse rate <50 is acceptable for 2nd and 3rd vaccinations if the subject is
otherwise healthy with documented sinus bradycardia at baseline.
6. Laboratory tests (alanine aminotransferase, creatinine, white blood cell count,
hemoglobin, and platelets) are all within protocol-defined reference ranges.
-The protocol-defined ranges for laboratory tests include (a) alanine aminotransferase
(ALT) of less than 1.25-times the upper reference limit, (b) creatinine less than 1.25
times the upper reference limit (c) white blood cells (WBC) between 3.3 x10^3/uL and
10.4 x10^3/uL, inclusive, (d) hemoglobin 11.4 g/dL or greater for females or 12.1 g/dL
or greater for males, (e) platelets greater than 130 x10^3/uL. Laboratory test results
for 2nd and 3rd vaccinations may be at Grade 1 if considered unrelated to study
product.
7. Urinalysis with no greater than trace protein and negative for glucose.
8. Female subjects of childbearing potential must agree to practice highly effective
contraception for a minimum of 30 days prior to study product exposure and for 30 days
after last vaccination.
- Female subjects who are surgically sterile via tubal sterilization, bilateral
oophorectomy or hysterectomy or who have been postmenopausal for greater than 1
year are not considered to be of childbearing potential.
- Highly effective methods of contraception are defined as having low failure rates
(i.e. less than 1% per year) when used consistently and correctly and may
include, but are not limited to, abstinence from intercourse with a male partner,
monogamous relationship with a vasectomized partner, male condoms or diaphragm
with spermicide, intrauterine devices, and licensed hormonal methods.
9. Female subjects of childbearing potential must have a negative urine or serum
pregnancy test within 24 hours prior to study vaccination.
10. Able to correctly answer all questions on the informed consent comprehension
questionnaire.
Exclusion Criteria:
1. Has the intention to become pregnant within 5 months after enrollment in this study.
2. Female subjects who are breastfeeding or plan to breastfeed at any given time from the
first study vaccination until 30 days after their last study vaccination.
3. Has an acute illness, including a documented oral temperature of 38.0 degrees celsius
or greater, within 72 hours prior to vaccination.
4. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic,
rheumatologic, autoimmune, diabetes, or renal disease by history, physical
examination, and/or laboratory studies.
5. Is immunosuppressed as a result of an underlying illness or treatment.
-Causes for immunosuppression may include, but are not limited to, poorly-controlled
diabetes mellitus, cirrhosis, renal insufficiency, active neoplastic disease or a
history of any hematologic malignancy, connective tissue disease, organ transplant.
6. Using or intends to continue using oral or parenteral steroids, high-dose inhaled
steroids (>800 µg/day of beclomethasone dipropionate or equivalent) or other
immunosuppressive or cytotoxic drugs.
7. Positive hepatitis B surface antigen (HBsAg)
8. Positive confirmatory test for HIV infection
9. Positive confirmatory test for hepatitis C virus (HCV) infection
10. Volunteer has had a history of alcohol or illicit drug abuse during the past 24
months.
11. Received immunoglobulin or other blood products (with exception of Rho D
immunoglobulin) within 90 days prior to study vaccination.
12. History of a severe allergic reaction or anaphylaxis to known components of the study
vaccines.
13. Has an acute or chronic medical condition that, in the opinion of the investigator,
would render participation in this study unsafe or would interfere with the evaluation
of responses.
-This includes, but is not limited to: known liver disease, renal disease,
neurological disorders, visual field defects, cardiac disorders, pulmonary disorders,
diabetes mellitus, and transplant recipients.
14. History of splenectomy
15. Is participating or plans to participate in another clinical trial with an
interventional agent during the duration of the study.
-This may include other licensed or unlicensed vaccines, drugs, biologics, devices,
blood products, or medications.
16. Received any licensed live vaccine within 30 days or any licensed inactivated vaccine
within 14 days prior to the first study vaccination.
17. Planned receipt of any vaccine from the first study vaccination through 28 days after
the last study vaccination.
18. Has any diagnosis, current or past, of schizophrenia, bipolar disease, or other
psychiatric diagnosis that may interfere with subject compliance or safety
evaluations.
19. 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.
20. Anti-Sm-TSP-2 IgE antibody level above ELISA reactivity threshold.
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