ACE527 Safety and Immunogenicity Study

This study has been completed.
Sponsor:
Collaborators:
Pierrel Research USA. Inc
Johns Hopkins University
Information provided by:
TD Vaccines A/S
ClinicalTrials.gov Identifier:
NCT00901654
First received: May 13, 2009
Last updated: January 28, 2010
Last verified: January 2010
  Purpose

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


Condition Intervention Phase
Enterotoxigenic E. Coli (ETEC) Infection
Biological: ACE527 vaccine
Biological: Placebo vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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

Further study details as provided by TD Vaccines A/S:

Primary Outcome Measures:
  • Adverse Events and determination of systemic immune response and mucosal immune response [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assessing intestinal colonization by the vaccine ACE527 [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: June 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACE527 Biological: ACE527 vaccine

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

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

Detailed Description:

The study is a phase I, single center, double-blind, placebo-controlled dose finding clinical study to evaluate the safety, tolerability and immunogenicity of the live attenuated, oral vaccine ACE527. The study is designed to evaluate 2 doses of the ACE527 in 2 cohorts. Each cohort will consist of approximately 18 subjects (healthy subjects), approximately 12 of them receiving ACE527 and approximately 6 receiving placebo.

Within a cohort, the second dose will only be given if safety and tolerability of the first dose is acceptable. This assessment will be based on evaluation of data up until Day 7 by the Independent Safety Committee (ISC) as per written guidance. The first dose of each cohort will be administered during an inpatient stay. Escalation to the next dose level will be dependent on an acceptable safety profile of the first dose at the previous dose level, based on evaluation of safety data by an Independent Safety Committee (ISC). The decision to administer the second dose at the higher level will also require review of the safety and tolerability of the second dose at the lower level.

The second dose will be administered at the outpatient clinic and the subjects will be observed for at least 60 minutes after vaccination prior to discharge from unit.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901654

Locations
United States, Maryland
Center for Immunization Research CIR
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
TD Vaccines A/S
Pierrel Research USA. Inc
Johns Hopkins University
Investigators
Principal Investigator: Clayton Harro, MD Johns Hopkins Bloomberg School of Public Health
  More Information

Additional Information:
No publications provided

Responsible Party: Ingelise Saunders/CEO, TD Vaccines A/S
ClinicalTrials.gov Identifier: NCT00901654     History of Changes
Other Study ID Numbers: ACE527-101
Study First Received: May 13, 2009
Last Updated: January 28, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by TD Vaccines A/S:
Vaccination
Diarrhea
Traveler's Diarrhea
ETEC
Enterotoxigenic E. coli

ClinicalTrials.gov processed this record on October 19, 2014