A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 To 85 Years, Who Will Each Receive 3 Doses Of Vaccine.

A Phase 1, Placebo-controlled, Randomized, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of An Adjuvanted Clostridium Difficile Vaccine Administered As A 3-dose Regimen In Healthy Adults Aged 50 To 85 Years

This study will investigate a clostridium difficile vaccine in healthy adults aged 50 to 85 years, who will each receive 3 doses of vaccine. Subjects will receive their vaccine doses at either months 0, 1, and 3 or days 1, 8, and 30. Subjects will be divided into 2 age groups (50-64 and 65-85 years of age). The study will assess how safe and tolerable the vaccine is, and also look at subjects' immune response to the vaccine.

Study Overview

• Status: Completed
• Conditions: Clostridium Difficile
• Intervention / Treatment: Biological: C. difficile vaccine with adjuvant; Biological: Placebo; Biological: C. difficile vaccine with adjuvant; Biological: placebo

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1W4R4
    • Clinique Medicale St-Louis (recherche) Inc.
  • Ontario
    • Toronto, Ontario, Canada, M9W 4L6
      • Manna Research Inc.
  • Quebec
    • Montreal, Quebec, Canada, H4N 3C5
      • Diex Research Montreal Inc
    • Sherbrooke, Quebec, Canada, J1H 1Z1
      • Diex Research Sherbrooke Inc.
• United States
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Vince & Associates Clinical Research
    • Overland Park, Kansas, United States, 66212
      • Vince & Associates Clinical Research, Inc.
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
    • Raleigh, North Carolina, United States, 27612
      • Carolina Phase I Research, LLC
  • Texas
    • Houston, Texas, United States, 77081
      • Texas Center for Drug Development, Inc.
  • Virginia
    • Annandale, Virginia, United States, 22003
      • Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male and female adults aged 50 to 85 years at enrollment

Exclusion Criteria:

• Proven or suspected prior episode of Clostridium difficile associated diarrhea.
• Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine.
• Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm Label: Month 0, 1 and 3 Schedule	Biological: C. difficile vaccine with adjuvant; C. difficile vaccine with adjuvant administered at Month 0, 1, and 3.; Biological: Placebo; Placebo administered at Month 0, 1, and 3.; Biological: C. difficile vaccine with adjuvant; C. difficile vaccine with adjuvant administered at day 1, 8, 30.
Experimental: Day 1, 8, and 30 Schedule	Biological: C. difficile vaccine with adjuvant; C. difficile vaccine with adjuvant administered at Month 0, 1, and 3.; Biological: C. difficile vaccine with adjuvant; C. difficile vaccine with adjuvant administered at day 1, 8, 30.; Biological: placebo; Placebo administered at Day 1, 8, and 30.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects reporting local reactions (pain, erythema, and induration) and their severity, as self reported on e-diaries.	7 days after vaccination
Proportion of subjects reporting systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) and their severity, as self reported on e-diaries.	7 days after vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects in each vaccine group with neutralizing antibody levels (in Neut units/mL) greater than or equal to specified threshold(s).	Up to 12 months post-dose 3
Proportion of subjects in each vaccine group with neutralizing antibody levels, expressed as geometric mean concentrations (GMCs) (in Neut units/mL).	Up to 12 months post-dose 3
Proportion of subjects in each vaccine group with a greater than or equal to 4 and higher fold-rises in neutralizing antibody levels (in Neut units/mL).	Up to 12 months post-dose 3

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2014
• Primary Completion (Actual): May 2, 2015
• Study Completion (Actual): May 5, 2015

Study Registration Dates

• First Submitted: December 17, 2013
• First Submitted That Met QC Criteria: January 30, 2014
• First Posted (Estimate): February 3, 2014

Study Record Updates

• Last Update Posted (Actual): December 4, 2018
• Last Update Submitted That Met QC Criteria: November 30, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Clostridium Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: B5091002