Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity

NCT00772954 | Terminated Phase 1 Results

• 1 other identifier: H-030-010
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

This Phase I, randomized, placebo-controlled, double-blinded, dose ranging study to assess the safety, tolerability, and immunogenicity of 2 dose levels of C. difficile vaccine. Population: healthy male and female adults, 18 to 55 years old.

Conditions

Clostridium Difficile Infection; Clostridium Difficile Diarrhea

Keywords

Clostridium difficile diarrhea; Clostridium difficile toxoid vaccine

Outcome Measures

Primary Outcomes (1)

• Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine.

  Day 0 up to 70 days post first vaccination

Study Arms (3)

Placebo vaccine group

PLACEBO COMPARATOR

Participants scheduled to receive a dose of placebo vaccine on Day 0, Day 28, and Day 56, respectively.

Biological: Vaccine diluent buffer

Clostridium Difficile Vaccine Group 1

EXPERIMENTAL

Participants scheduled to receive a dose of 50 μg Clostridium Difficile vaccine on Day 0, Day 28, and Day 56, respectively.

Biological: Clostridium difficile toxoid vaccine (50 μg)

Clostridium Difficile Vaccine Group 2

EXPERIMENTAL

Participants scheduled to receive a dose of 100 μg Clostridium Difficile vaccine on Day 0, Day 28, and Day 56, respectively.

Biological: Clostridium difficile toxoid vaccine (100 μg)

Interventions

Vaccine diluent buffer BIOLOGICAL

0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.

Placebo vaccine group

Clostridium difficile toxoid vaccine (50 μg) BIOLOGICAL

0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.

Clostridium Difficile Vaccine Group 1

Clostridium difficile toxoid vaccine (100 μg) BIOLOGICAL

0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.

Clostridium Difficile Vaccine Group 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult males or females, 18 - 55 years in good general health

You may not qualify if:

• Evidence of current C. difficile infection, as determined by a positive stool C. difficile cytotoxin assay at screening
• Evidence of any previous antibiotic-associated diarrhea caused by any etiology including C. difficile that required medical intervention or medication
• Active or inactive irritable bowel disease, chronic abdominal pain, chronic diarrhea of any etiology, or inflammatory bowel disease.

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Limitations and Caveats

This study was terminated early in light of issues with CTM stability. All other study procedures and visits were performed per protocol.

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Dennis N Morrison, D.O.

  Bio-Kinetic Clinical Applications, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2008
• First Posted: October 15, 2008
• Study Start: March 1, 2006
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: May 21, 2012
• Results First Posted: May 21, 2012

Record last verified: 2012-04