ACE527 Safety and Immunogenicity Study

Completed · Phase 1 · Has a placebo group

Conditions studied: Enterotoxigenic E. Coli (ETEC) Infection

In brief

The purpose of this study is to evaluate the safety and immune response to ACE527.

Key facts

Study ID

NCT00901654

Run by

TD Vaccines A/S

People needed

36

Starts

2009-06-01

Expected to finish

2009-11-01

Last updated by the study team

2010-01-29

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Center for Immunization Research CIR — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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