Evaluation of Safety, Reactogenicity and Immunogenicity of Fractional-dose Inactivated Polio Vaccine (fIPV) Given Intradermally With Double Mutant Enterotoxigenic Escherichia Coli Heat Labile Toxin (dmLT) Adjuvant

This is an interventional prevention trial for Polio focused on measuring inactivated polio vaccine (IPV), fractional-dose inactivated polio vaccine (fIPV), double mutant [LT(R192G/L211A)] Enterotoxigenic E coli heat toxin (dmLT) Read More

Inclusion Criteria:

1. Adult male or female age 18-45 years, inclusive
2. Signed informed consent form prior to initiation of any study activity
3. Good general health as determined by review of medical history and physical exam
4. Agrees to complete all study visits and procedures for the duration of the study
5. Receipt of childhood vaccine series of Inactivated Polio Vaccine with verification of immunization record. American College of Immunization Practices (AICP) required that OPV use be discontinued by January 2000. Therefore, polio vaccines given after January 2000 in the U.S. are known to be IPV. If the documentation is unclear of the type of polio vaccine given between 1998 and 2000, additional confirmation of the type should be attempted to determine eligibility.
6. Agrees to storage of specimens for future research
7. Females of child bearing potential only: willing to use effective contraception from the following reliable methods through the first 28 days of the study: hormonal birth control, condoms with spermicide, diaphragm with spermicide, surgical sterilization, and intrauterine device. All female subjects will be considered as having childbearing potential except for those who have had a hysterectomy or tubal ligation or have no internal female organs. Transgender men who have internal female organs will be considered of childbearing potential and should be willing to use effective contraception during the trial. Exception: females who have sex with females (exclusively) and have no intention of conceiving a child during the study will not be required to use contraception.

Exclusion Criteria:

1. History of receipt of any oral polio vaccine. Subjects will be required to present their childhood immunization record during the screening process. Subjects will be excluded if the immunization record indicates receipt of any dose of oral polio vaccine or if only 'polio vaccine' is listed on the record without specifying whether oral or inactivated polio vaccine was administered.
2. Currently lactating, breastfeeding or pregnant.
3. Clinical laboratory values ≥ Grade 2 on hematology or comprehensive metabolic panel, as defined in this protocol.
4. Febrile illness (≥38.0°C (100.4°F) or acute gastroenteritis within 48 hours prior to administration of IP
5. History of antimicrobial treatment in the 2 weeks before administration of IP
6. Receipt of a live vaccine within 28 days or a killed vaccine within 14 days prior to inoculation, or anticipated receipt of any vaccine during the 28 days following inoculation.
7. History of a severe allergic reaction or anaphylaxis
8. History of Guillian-Barre Syndrome
9. Known history of hypersensitivity to any component of IPV to include: 2-phenoxyethanol, formaldehyde, neomycin, streptomycin, and polymyxin B
10. Self-reported or suspected immunodeficiency, or receipt of immunosuppressive therapy within the preceding 6 months, or long-term systemic corticosteroid therapy. An immunosuppressive dose of corticosteroids (excluding topical or nasal) is defined as >10 mg of prednisone equivalent per day for >14 days.
11. Asplenia
12. Receipt of blood products within the past 6 months, including transfusions or immunoglobulin, or anticipated receipt of any blood products or immunoglobulins during the 28 days following inoculation
13. Anticipated receipt of any investigational agent in the 28 days before or after receipt of investigational product
14. Abnormal routine bowel habits as defined by fewer than three stools per week in the past 6 months
15. Regular use (weekly or more often) of laxatives, anti-diarrheal, anti-constipation, or antacid therapy
16. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease based on history and physical exam. This includes any chronic medical condition (examples include diabetes mellitus, hypertension, autoimmune disorders, cardiovascular and renal diseases).
17. Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the subject's ability to understand and cooperative with the requirements of the study protocol.
18. Any other condition that, in the opinion of the study clinician, would jeopardize the safety or rights of a subject participating