Clostridium Difficile Vaccine Safety, Tolerability, and Immunogenicity Study in Japanese Adults

NCT02725437 | Completed Phase 1 DMC

• 1 other identifier: B5091010
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The first-in-Japanese study B5091010 has been designed to evaluate the safety, tolerability, and immunogenicity of 2 antigen dose levels of C difficile vaccine when administered as one of two 3-dose regimens to healthy Japanese adults aged 65 to 85 years.

Conditions

Clostridium Difficile Associated Disease

Outcome Measures

Primary Outcomes (5)

• Proportions of subjects reporting local reactions (pain, erythema, and induration) and their severity, as self-reported on e-diaries

  Up to 14 days after each vaccination

• Proportions 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

  Up to 14 days after each vaccination

• Proportions of subjects reporting AEs (categorized according to the Medical Dictionary for Regulatory Activities [MedDRA])

  From the first vaccination up to 28 days after the last vaccination

• Proportions of subjects reporting SAEs (categorized according to the Medical Dictionary for Regulatory Activities [MedDRA])

  From the first vaccination until 6 months after the last vaccination

• Proportions of subjects with abnormal hematology and blood chemistry laboratory assessments

  7 days or 14 days after each vaccination

Secondary Outcomes (8)

• Toxin A- and toxin B-specific neutralizing antibody levels, expressed as geometric mean concentrations

  Up to 6 months after dose 3

• Geometric mean fold rises in toxin A- and toxin B-specific neutralizing antibody levels

  Up to 6 months after dose 3

• Proportions of subjects in each vaccine group with toxin A-specific neutralizing antibody level ≥ the specified threshold for toxin A

  Up to 6 months after dose 3

• Proportions of subjects in each vaccine group with toxin B-specific neutralizing antibody level ≥ the specified threshold for toxin B

  Up to 6 months after dose 3

• Proportions of subjects in each vaccine group with both toxin A- and toxin B-specific neutralizing antibody levels ≥ the specified threshold for toxin A and the specified threshold for toxin B, respectively

  Up to 6 months after dose 3

Study Arms (6)

Low-dose C. difficile Vaccine (accelerated schedule)

EXPERIMENTAL

Biological: Clostridium difficile Vaccine

High-dose C. difficile Vaccine (accelerated schedule)

EXPERIMENTAL

Biological: Clostridium difficile Vaccine

Placebo (accelerated schedule)

PLACEBO COMPARATOR

Biological: Placebo

Low-dose C. difficile Vaccine (non-accelerated schedule)

EXPERIMENTAL

Biological: Clostridium difficile Vaccine

High-dose C. difficile Vaccine (non-accelerated schedule)

EXPERIMENTAL

Biological: Clostridium difficile Vaccine

Placebo (non-accelerated schedule)

PLACEBO COMPARATOR

Biological: Placebo

Interventions

Clostridium difficile Vaccine BIOLOGICAL

0.5 mL intramuscular injection

High-dose C. difficile Vaccine (accelerated schedule); High-dose C. difficile Vaccine (non-accelerated schedule); Low-dose C. difficile Vaccine (accelerated schedule); Low-dose C. difficile Vaccine (non-accelerated schedule)

Placebo BIOLOGICAL

0.5 mL intramuscular injection

Placebo (accelerated schedule); Placebo (non-accelerated schedule)

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Healthy male and female adults
• Aged 65 to 85 years

You may not qualify if:

• Proven or suspected prior episode of Clostridium difficile associated diarrhea
• Unstable chronic medical condition
• Disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine
• Serious chronic medical disorders
• Bleeding diathesis or condition associated with prolonged bleeding time that may contraindicate intramuscular injection
• Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components
• Subjects with congenital or acquired immunodeficiency disorders
• Subjects with rheumatologic disorders or other illnesses requiring chronic treatment with known immunosuppressant medications
• Active or treated leukemia or lymphoma or bone marrow disorder
• Residence in a nursing home or other long-term care facility, or requirement for semiskilled nursing care or assisted living
• Abnormality in screening hematology and/or blood chemistry laboratory values

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

SOUSEIKAI Sumida Hospital (formerly Medical Co. LTA Sumida Hospital)

Sumida-ku, Tokyo, 130-0004, Japan

Location

SOUSEIKAI PS Clinic (formerly Medical Co. LTA PS Clinic)

Fukuoka, 812-0025, Japan

Location

Related Publications (1)

• Inoue M, Yonemura T, de Solom R, Yamaji M, Aizawa M, Knirsch C, Pride MW, Jansen KU, Gruber W, Webber C. A phase 1 randomized study assessing safety and immunogenicity of two 3-dose regimens of a Clostridium difficile vaccine in healthy older Japanese adults. Vaccine. 2019 May 1;37(19):2600-2607. doi: 10.1016/j.vaccine.2019.03.014. Epub 2019 Apr 5.

  PMID: 30962095 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.
• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: April 1, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: July 13, 2018

Record last verified: 2018-07

Locations

JP (2)