| Eligibility |
Inclusion Criteria:
-Male or female age 18-45, inclusive. -Healthy as judged by the Principal Investigator (PI)
and determined by medical history, physical examination, vital signs, screening
laboratories, and medication history. -Capable of understanding, consenting and complying
with the entire study protocol including the inpatient period. -Female subjects must be of
non-childbearing potential, or if of childbearing potential (as determined by the
investigator) must be practicing abstinence or using an effective licensed method of birth
control (e.g., oral contraceptives; diaphragm or condom in combination with contraceptive
jelly, cream, or foam; intrauterine contraceptive device, or Depo-Provera; skin patch;
vaginal ring or cervical cap) for 30 days prior to vaccination and must agree to continue
such precautions during the study and for 30 days after the Day 28 study visit. -Male
subjects must agree not to father a child during the study and for 90 days after the Day 0
study visit. -Provide voluntary written informed consent and attained at least 70% on an
examination about the study on the first attempt. -Have normal screening laboratories for
serum glutamic pyruvic transaminase (SGPT) alanine aminotransferase (ALT), creatinine,
sodium, potassium, total white blood count (WBC), hemoglobin, neutrophils, lymphocytes,
platelets, urine protein, urine glucose and urine red blood cells (RBC).
Exclusion Criteria:
-Women who are pregnant or lactating or have a positive serum pregnancy test at screening
or upon admission to inpatient facility. -Subjects who are immunocompromised or
immunodeficient, or have had a prior malignancy (exception: a history of basal cell or
squamous cell carcinoma in remission without treatment for more than 5 years prior to study
entry). -History of clinically significant chronic illness or other condition requiring
chronic medication therapy. -History of malabsorption or maldigestion disorder (e.g.,
celiac sprue), major gastrointestinal (GI) surgery, or any other chronic GI disorders that
would interfere with the study or the investigational product. -Any current or past use of
immunosuppressive medications including inhaled steroids (e.g., for asthma) within 6 months
of screening. -Recent (e.g., within 5 years) history of travel to a cholera or
Enterotoxigenic Escherichia coli (ETEC) endemic area, raised in a cholera or ETEC endemic
area or a history of raising a child from an endemic area for cholera or ETEC. Individuals
who may work with Vibrio (V) cholerae or ETEC in the laboratory are also excluded.
-Vaccination against or infection with cholera or E. coli, or participation in a clinical
trial using cholera or ETEC vaccine or organisms at any time. -History of drug or alcohol
abuse any time in the last 6 months. -Presence of HIV antibody, hepatitis C antibody, or
positive hepatitis B surface antigen. -Clinically abnormal screening electrocardiogram
(ECG) defined as pathologic Q waves and significant ST-T wave changes; criteria for left
ventricular hypertrophy; and any non-sinus rhythm excluding isolated premature atrial
contractions. -Presence of bacterial or parasitic pathogens in stool culture in a screening
stool examination. -IgA (immunoglobulin) deficiency. -A change in subject's normal stool
pattern within 3 months of screening visit. A normal stool pattern is defined as 3 to 21
stools per week. -Any known allergy or sensitivity to Ciprofloxacin. -Have any known
allergy to components of the vaccine [M9 minimal salts, glycerin, dextrose anhydrous,
sodium chloride, peptone (vegetable) acid hydrolysate, magnesium sulfate heptahydrate, and
aspartame] or placebo/bicarbonate buffer (water, sodium bicarbonate, ascorbic acid, and
aspartame). -Any medical illness requiring a new prescription medication or hospitalization
during the screening period or having a temperature greater than or equal to 38.0 degrees
Celsius during the 2 weeks prior to investigational product administration (Day 0).
-Administration of any vaccine, licensed or investigational, or any investigational product
within 30 days of investigational product administration (Day 0) or any plan for
participation in another investigational trial during this study. -Use of antibiotics
within 7 days of investigational product administration (Day 0). -Use of laxatives for hard
or infrequent stools one or more times in a month in any of the 3 months prior to
enrollment. -Use of any H2 receptor antagonists (e.g., Tagamet®, Zantac®, and Pepcid®),
proton pump inhibitors (e.g., Prilosec® over the counter (OTC), Protonix®, and Prevacid®),
or prescription acid suppression medication or OTC antacids within 72 hours of
investigational product administration. -Use of prescription and OTC medications that
contain acetaminophen, aspirin, ibuprofen, and other nonsteroidal anti-inflammatory drugs
within 48 hours prior to investigational product administration. -Employment as a
commercial food handler, day care worker, or health care worker involved in direct patient
contact. Subjects with children less than 2 years old at home or with household contacts
that are immunocompromised, pregnant or breast-feeding. -Any other condition or
responsibili ty, such as a medical, psychiatric, or social condition or occupational
responsibility that, in the judgment of the investigator, would interfere with or serve as
a contraindication to the subject's participation in the protocol or assessment of the
investigational product. -Subjects who are unwilling or unable to cease smoking for the
duration of the inpatient stay. -Subjects who are unable to pass a test that describes
cholera and ETEC diarrhea and explains the requirements of the clinical trial. Subjects
must score a minimum of 70 percent upon the first attempt. -Subjects will be excluded if
their screening laboratory test results fall outside of the laboratory normal; however,
transaminase levels [alanine aminotransferase (ALT)] and creatinine levels (Cr) below the
lower limit of "normal" will not be an exclusion criterion. -Subjects with Phenylketonuria
(PKU) will be excluded because the investigational product (vaccine) bicarbonate buffer
contains aspartame.
|
