Safety of Sublingual dmLT for ETEC

Who cannot join

• Women who are pregnant or lactating or have a positive serum pregnancy test at screening or positive urine pregnancy test prior to vaccination. - Abnormal vital signs, defined as: -- Hypertension (systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg) at rest on 2 separate days; or -- Palpated heart rate <55 or >100 beats/minute at rest on 2 separate days*; or *If heart rate between 45 and 55, subjects may be enrolled with an EKG that demonstrates normal sinus rhythm and does not document conduction disorders. --Temperature >/= 38.0 degrees C (100.4 degrees F) - Symptoms of an acute self-limited illness, including a temperature >/= 38.0 degrees C (100.4 degrees F), such as an upper respiratory infection or gastroenteritis within 7 days of administration of dmLT. - Positive hepatitis C, or HIV serology or positive hepatitis B serology not consistent with prior hepatitis B immunization. - Have a positive urine drug screen for opiates. - Subjects who are unwilling or unable to cease smoking for the duration of the overnight stay. - History of antimicrobial treatment in the 2 weeks before administration of dmLT. - Received previous experimental E. coli, LT, or cholera vaccines or live E. coli or Vibrio cholera challenges; or previous infection with cholera or diarrheagenic E. coli. - Abnormal routine bowel habits as defined by fewer than three stools per week or more than two stools per day in the past 6 months. - History of chronic gastrointestinal illness, including severe dyspepsia (mild or moderate heartburn or epigastric pain occurring no more than three times per week is permitted), or other significant gastrointestinal tract disease. - Regular use (weekly or more often) of laxatives, anti-diarrheal, anti-constipation, or antacid therapy. - History of major gastrointestinal surgery, excluding uncomplicated appendectomy or cholecystectomy. - Long-term use, defined as longer than 14 days, of oral steroids, parenteral steroids, or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. (Nasal and topical steroids are allowed). - Have a diagnosis of schizophrenia or other major psychiatric diagnosis. - Are receiving the following psychiatric drugs: aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, chlorprothixene, chlorpromazine, perphenazine, trifluopromazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate, or lithium citrate. NOTE: Subjects who are receiving a single antidepressant drug and are stable for at least 3 months before enrollment without de-compensating symptoms are allowed to be enrolled in the study. - History of receiving Ig or other blood product within the 3 months before enrollment in this study. - Traveled to ETEC-endemic areas, defined as Africa, Middle East, South Asia, or Central or South America within the past 3 years or raised in a cholera or ETEC endemic area. - Received any licensed vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) before enrollment in this study or plans to receive any licensed vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) after any study vaccination. - An acute or chronic medical condition that, in the opinion of the investigator, would render administration of dmLT unsafe or would interfere with the evaluation of responses. This includes, but is not limited to: known or suspected immunodeficiency, known chronic liver disease, significant renal disease, unstable or pr ogressive neurological disorders, history of diabetes, cancer (other than a healed skin lesion), heart disease (in the hospital for a heart attack, history of irregular heart beat or fainting caused by an irregular heartbeat), unconsciousness (other than a single brief "concussion"), seizures (other than with fever when subject was a child <5 years old), asthma requiring treatment with inhaler or medication in the prior 2 years, autoimmune disease or eating disorder, and transplant recipients. - Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month before enrollment in this study or expects to receive an experimental agent during the study. - History of alcohol or drug abuse in the last 5 years. - Plans to travel outside of the USA in the time between study vaccination and 28 days following the final vaccination. - Unable to spend up to 48 hours at an overnight facility following the administration of Dose 1. - 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. - Use of prescription or over-the-counter (OTC) medications that contain acetaminophen, aspirin, ibuprofen, and other non-steroidal anti-inflammatory drugs within 48 hours prior to receiving the investigational product. - Use of prescription acid suppression medication or OTC antacids within 72 hours of investigational product administration. - Subjects with autoimmune disorders, chronic inflammatory disorders or neurological disorders with a potential autoimmune correlation. - Subjects who planned to travel to an ETEC-endemic area, defined as Africa, Middle East, South Asia, or Central or South America, during the long-term safety follow-up period (6 months) of the study. - Known allergies to study compound. - Special populations, e.g., non-English speakers, children, illiterate or non-writing individuals, vulnerable populations. - Any abnormality of the palate.