ACE527 Safety and Immunogenicity Study

NCT00901654 | Completed Phase 1 DMC

• 1 other identifier: ACE527-101
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Enterotoxigenic E. Coli (ETEC) Infection

Keywords

Vaccination; Diarrhea; Traveler's Diarrhea; ETEC; Enterotoxigenic E. coli

Outcome Measures

Primary Outcomes (1)

• Adverse Events and determination of systemic immune response and mucosal immune response

  13 weeks

Secondary Outcomes (1)

• Assessing intestinal colonization by the vaccine ACE527

  13 weeks

Study Arms (2)

ACE527

EXPERIMENTAL

Biological: ACE527 vaccine

Placebo comparator

PLACEBO COMPARATOR

Biological: Placebo vaccine

Interventions

ACE527 vaccine BIOLOGICAL

First cohort: Two doses, each of 3x10\^9 cfu of each strain (9x10\^9 cfu total per dose) administered on Days 0 and Day 21 (out-patient). Second cohort: Two doses, each of 3x10\^10 cfu of each strain (9x10\^10 cfu total per dose) administered on Days 0 and Day 21

ACE527

Placebo vaccine BIOLOGICAL

First and second cohort: The placebo vaccine will be administered at Days 0 and Days 21.

Placebo comparator

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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).

Sponsors & Collaborators

• TD Vaccines A/S: lead
• Pierrel Research USA, Inc.: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

Center for Immunization Research CIR

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Infections; Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clayton Harro, MD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 13, 2009
• First Posted: May 14, 2009
• Study Start: June 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 29, 2010

Record last verified: 2010-01

Locations

US (1)