The purpose of this study is to evaluate the safety and immune response to ACE527.
Biological: ACE527 vaccine
Biological: Placebo vaccine
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Locations near you
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Full eligibility criteria for NCT00901654
Ages eligible for Study
18 Years to 50 Years
Genders eligible for Study
Accepts Healthy Volunteers
Male or female age ≥18 and ≤50 years.
General good health, without clinically significant medical illness, physical examination findings or laboratory abnormalities, as determined by the Principal Investigator (PI) or PI in consultation with the medical monitor (MM) and sponsor.
Negative serum pregnancy test at screening and a negative urine pregnancy test before immunization for female subjects of childbearing potential. Females of childbearing potential must not be breastfeeding and must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable. Female subjects unable to bear children (e.g. tubal ligation or hysterectomy) must have negative pregnancy tests.
Working as a food handler, in child-care or as a healthcare worker with direct patient contact.
Have household contacts who are <2 years old or >80 years old or infirm or immunocompromised (for reasons including corticosteroid therapy, HIV infection, cancer chemotherapy, or other chronic debilitating disease)
Pregnancy, risk of pregnancy, or lactation (female subjects only).
Abnormal stool pattern (fewer than 3 per week or more than 3 per day).
Regular use of laxatives, antacids, or other agents to lower stomach acidity.
Use of any medication known to affect the immune function (e.g., corticosteroids and others) within 30 days preceding the first vaccination or planned use during the active study period. (Topical and intra-articular steroids will not exclude subjects).
Known allergy to quinolones, trimethoprim-sulfamethoxazole or penicillins.
Symptoms consistent with Traveller's Diarrhea concurrent with travel to countries where ETEC infection in endemic (most of the developing world) within 2 years prior to vaccination.
Received vaccination against, or ingestion of, ETEC, cholera toxin, or LT toxin within 3 years prior to vaccination.
Use of antibiotics during the 7 days prior to vaccination and/or proton pump inhibitors, H2 blockers, or antacids within 48 hours prior to vaccination.
History of diarrhea in the 7 days prior to vaccination (outpatient diarrhea is defined as ≥ 3 unformed loose stools in 24 hours).
All locations for NCT00901654
United States (1)
Center for Immunization Research CIR
Baltimore, Maryland, United States, 21224
View full eligibility
Tris trial is registered with FDA with number: NCT00901654. The sponsor of the trial is TD Vaccines A/S and it is looking for 36 volunteers for the current phase.
Official trial title: A Phase I, Single Center, Double-Blind, Placebo-controlled Dose Finding Clinical Study to Evaluate the Safety and Immunogenicity of the Live Attenuated, Oral Vaccine ACE527
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