Safety Study of Chimeric Vaccine to Prevent ETEC Diarrhea
Condition: Escherichia Coli Infection
MeSH terms: Escherichia coli Infections
Intervention: Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5; Recombinant fimbrial adhesin dscCfaE; Modified E. coli heat labile enterotoxin LTR192G
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to determine if immunization with a chimeric E. coli protein,
      dsc14CfaE-sCT2/LTB5, is safe and immunogenic when administered by vaccination under the skin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, adult, male or female, age 18 to 45 years (inclusive) at the time of
             enrollment.

          -  Completion and review of comprehension test (achieved > 70% accuracy).

          -  Signed informed consent document.

          -  Available for the required follow-up period and scheduled clinic visits.

          -  Women: Negative pregnancy test with understanding (through informed consent process)
             to not become pregnant during the study or within three (3) months following study
             completion.

        Exclusion Criteria:

          -  Health problems (for example, chronic medical conditions such as psychiatric
             conditions, diabetes mellitus, hypertension or any other conditions that might place
             the subjects at increased risk of adverse events. Study clinicians, in consultation
             with the PI, will use clinical judgment on a case-by-case basis to assess safety risks
             under this criterion. The PI will consult with the Research Monitor as appropriate.

          -  Clinically significant abnormalities on physical examination.

          -  Use of immunosuppressive medications (systemic corticosteroids or chemotherapeutics
             that may influence antibody development), or immunosuppressive illness, including IgA
             deficiency (defined by serum IgA below the detectable limit).

          -  Women who are pregnant or planning to become pregnant during the study period plus 3
             months beyond the last study safety visit and currently nursing women.

          -  Participation in research involving another investigational product (defined as
             receipt of investigational product or exposure to invasive investigational device) 30
             days before planned date of first vaccination or anytime through the last study safety
             visit.

          -  Positive blood test for HBsAg, HCV, HIV-1.

          -  Clinically significant abnormalities on basic laboratory screening.

          -  Exclusionary skin history/findings that would confound assessment or prevent
             appropriate local monitoring of AEs, or possibly increase the risk of an AE.

          -  History of chronic skin disease (clinician judgment).

          -  History of atopy such as active eczema.

          -  Acute skin infection/eruptions on the upper arms including fungal infections, severe
             acne or active contact dermatitis.

          -  Allergies that may increase the risk of AEs.

          -  Regular use (weekly or more often) of antidiarrheal, anti-constipation, or antacid
             therapy.

          -  Abnormal stool pattern (fewer than 3 stools per week or more than 3 stools per day) on
             a regular basis; loose or liquid stools on other than an occasional basis.

          -  Prior exposure to ETEC or Vibrio cholera.

          -  History of microbiologically confirmed ETEC or cholera infection.

          -  Travel to countries where ETEC or V. cholera or other enteric infections are endemic
             (most of the developing world) within two years prior to dosing clinician judgment).

          -  Received previous experimental ETEC or V. cholera vaccine or live ETEC or V. cholera
             challenge.

          -  Occupation involving handling of ETEC or V. cholera currently, or in the past 3 years.